Capstone Design Paper Portion from revised paper

Capstone Design Paper: Management of Weight Gain in Adults with Schizophrenia on Second-

Generation Antipsychotic

Weight gain and obesity are problems prevalent in patients with schizophrenia compared

to the general population. The prevalence of obesity in people with schizophrenia has been

reported to be anywhere from 1.5 to 4 times higher than in the general population (Faulkner,

2010). Even though weight gain and obesity may be a problem for individuals with

schizophrenia before the start of treatment with antipsychotics, studies indicate that use of

second-generation antipsychotics (SGA) leads to significant weight gain in this population

(Manu et al., 2015; Panariello, De Luca, & de Bartolomeis, 2010; Vieweg, & Hasnain, 2012).

The SGA-induced weight gain and obesity in patients with schizophrenia has become a

nationwide epidemic that lurks in the American population and a global problem as well.

Therefore, the purpose of this change project is to delineate the exercise program and education

on dietary strategies as evidence-based practice interventions which will address the weight and

obesity problem in patients with schizophrenia on SGA.

Problem of Interest

The use of SGAs has revolutionized the treatment of patients with psychotic features,

particularly in those with schizophrenia. With advancement in scientific research on

psychopharmacology, SGAs have become the first line of treatment for mood disorders and

psychosis in patients with schizophrenia, and other related disorders, such as Bipolar (Vieweg, &

Hasnain, 2012). Although excess body weight in patients on antipsychotics has been

documented for over 40 years, with 40-80% of such individuals experiencing weight (Maayan, &

Corell, 2012), this side effect is especially problematic in patients with schizophrenia who are

taking SGA.

While SGAs were initially thought to have fewer side effects than the first-generation

(Vieweg, & Hasnain, 2012), it quickly became evident that these medications were associated

with rapid increase in weight in the first few months, and was the major cause of obesity for

patients with schizophrenia ((Fenton & Chavez,2006; Keltner, 2006). The increase in weight for

a patient with schizophrenia is due in part to SGA's induced-hypermetabolic state that may have

an adjuvant role in increased appetite, which causes an increase in caloric intake due to

frequently eating at night (Manu et al., 2015). This behavior greatly contributes to the weight

gain.

Panariello, De Luca, and de Bartolomeis, (2010) reported that significant weight gain

related to the use of SGAs may affect the compliance of pharmacotherapy in patients with

schizophrenia because of the stigma associated with obesity and negative body image. Vieweg

and Hasnain, (2012) and Weiden, Mackell, and McDonnell, (2004) also posit that there is a

significant, positive association between obesity and subjective distress from weight gain and

medication noncompliance. Maayan and Corell, (2012) and Joe and Lee, (2016) indicated that

medication noncompliance is a major barrier to better health outcomes for people with

schizophrenia, and is a major risk factor for relapse. Relapse often leads to the reoccurrence of

psychotic symptoms. This eventually may lead to hospitalization, which further complicates the

treatment of patients with schizophrenia. Weight gain and obesity also increase the risk of onset

of type 2 diabetes mellitus and cardiovascular disorders, which affect the quality of life in this

population (Manu et al., (2015).

Studies also indicated that the medical service utilization by patients with schizophrenia

who were non-adherent to medication, was related to a higher number of medical comorbidities,

and was found to be responsible for 60% of premature deaths in patients with schizophrenia (Joe

and Lee, 2016; Manu et al., (2015). The chronic medical conditions related to weight gain and

obesity such as diabetes mellitus, hypertension, and hyperlipidemia in patients with

schizophrenia on SGA have also been associated with an increased annual health care costs for

their treatment and management (Chwastiak et al., 2009). Therefore, weight gain and obesity in

patients with schizophrenia is a significant clinical problem that warrants the need for an

evidence-based practice (EBP) intervention.

Review of the Literature

In order to guarantee that the uppermost quality of healthcare is being provided along

with producing best patient outcomes, EBP is the most relied delivery care system (Melnyk and

Fineout-Overholt, 2015). Patients with schizophrenia have a higher propensity for weight gain

and obesity compared to the general population (Vella and Pai, 2011). Weight gain and obesity

have been associated with increased risk of health-related complications, which contribute

significantly to the poor quality of life and increased risk of death in patients with schizophrenia

on SGAs (Vandyk & Baker, 2012). Based on the identified clinical problem of weight gain in

patients with schizophrenia on SGAs, a literature review identified strong evidence that supports

healthy lifestyles changes in weight management.

Findings from several studies indicate that healthy lifestyle change through exercise and

dietary strategies are the interventions of choice to help with weight management in patients

with schizophrenia on SGAs (Faulkner, Cohn, and Remington, 2010; Manu et al., 2015; Poulin

et al., 2007; Usher, Park, Foster, and Buettner, 2013). Faulkner, Cohn, and Remington (2010)

conducted a systematic review of randomized controlled trials (RTCs) to determine the effects

of both pharmacological (excluding medication switching) and non-pharmacological strategies

for reducing weight gain in patients with schizophrenia. The authors reported that there was

significantly greater weight reduction in the cognitive behavioral interventions group involving

lifestyle changes (n=129, 3RCTs, weighted mean difference (WMD) -1.69kg, fixed 95% CI[ -

2.8 TO -0.6]) compared with standard care, while no significant change in weight reduction

was found with pharmacological intervention(n=112, WMD, -0.27, fixed 95% CI [-2.2 to

1.6]). Faulkner, Cohn, and Remington (2010) concluded that initiating and maintaining a low-

cost exercise program and discussions on healthy eating as a healthy lifestyle change had a

better outcome in weight management compared to pharmacological interventions for patients

with schizophrenia on SGAs.

Manu et al. (2015) conducted a meta-analysis of RCTs published between 2005 and 2014. The

authors reported that following behavioral interventions of exercise and dietary management in

810 patients in the meta-analysis, the results indicated a significant reduction in weight (-3.13kg;

BMI (-0.94kg/m²), waist circumference (-3,6cm) and body fat (-2.82%). The authors concluded

that intensive lifestyle interventions with increased physical activity involving walking 2-3 times

per week for 30minutes, with endurance activities and, adherence to diet management of reduced

caloric intake, the amount of weight loss was enhanced and maintained.

Usher, Park, Foster, and Buettner, (2013) conducted an experimental randomized control

trial on 104 participants (mean BMI of 33.71kg/m²) with schizophrenia (84.2%) and other mental

disorders (15.8%), to measure weight loss and medication compliance. The authors concluded

that multi-modal approaches which include a combination of education, healthy lifestyle,

behavioral, and exercise intervention with diet strategies are more likely to be effective in

reducing weight in the longer term than any of the interventions on their own.

In another study by Poulin et al. (2007), the authors conducted a prospective,

comparative, open and naturalistic; a descriptive and qualitative study and concluded that body

weight and metabolic risk profile in patients with schizophrenia receiving SGAs can be managed

with a weight control program including physical activity. Dietary strategies were not included in

this study. Therefore, these studies indicate that there is a strong EBP research to support healthy

lifestyle changes through exercise program and education on dietary strategies as an efficacious

intervention to manage weight gain in patients with schizophrenia on SGA.

Based on the rigorous review of the literature, the EBP interventions of an exercise program

and education on dietary strategies will be implemented for the practice change project in a six

weeks periods to address the weight gain and obesity problem at the clinical site for patients with

schizophrenia treated with SGA.

Purpose of Project

This is an evidence-based practice (EBP) change project that is based on research

findings that strongly support the use of an exercise program and education on dietary strategies

to manage weight gain problem in patients with schizophrenia on SGAs, with the ultimate goal

of improving medication adherence and overall treatment goals in this population. The practice

change project will involve providing education on the modalities of engaging in an exercise

program and dietary strategies as an EBP intervention to improve weight management and

enhance body image in patients with schizophrenia treated with SGAs.

In the practice change project the shorter version of the Body Shape Questionnaire (BSQ-

14) (Dowson and Henderson, 2001) and Body Mass Index (BMI) (Arterburn et al. 2010) tools

will be used as pre-intervention measures used to evaluate the perception of body shape which

greatly affects the body image in relation to weight. The focus will be to measure the effect of

weight gain and obesity on the body image as a subjective parameter in relation to weight pre-

intervention, followed by EBP implementation of an exercise program and education on dietary

strategies for the purpose of weight management. The intended outcomes of the intervention will

be the following: 1) weight loss; 2) and enhanced body image, which will lead to improved

medication adherence, all of which will contribute to improved overall treatment outcomes.

There will be other benefits tied to these outcomes, such as increased knowledge for weight

management, improved mental well-being, improved sleep, and decreased risks for chronic

diseases, such as diabetes type 2, hypertension and dyslipidemia which contribute to

cardiovascular-related deaths.

Project Management

Readiness for change.

The leadership in the organization where the change project will be implemented has

been very supportive to the project manager's ideas from the initial phase since this will be the

first change project of its kind in this organization to address the problem of weight gain and

obesity in patients with schizophrenia. All of the stakeholders; the top management, chief

psychiatrist, the director of the program, and also two other psychiatric nurse practitioners in the

clinical site were on board and approved the suggested interventions to the change project to

address the clinical problem. The organization is ready for the change because the top

management have fully embraced the change project and is willing to apportion resources

towards the success of this change project since its goal and outcomes will not only help the

clients stay healthy and reduce medical conditions related to weight gain and obesity but also

will eventually be cost-effective in treating patient with schizophrenia and other patients

psychotics treated with second-generation antipsychotics. The director of the chief operation

officer agreed to equip the gym and provide all of the necessary materials and any official

guidance needed for implementation of the intervention.

Interdisciplinary Collaboration.

Successful implementation of a change project is based on the collaboration between a

project manager/implementer and a team of inter-professional who will work together to ensure

that the goals set at the beginning of the project are achieved with best outcomes (Harris,

Roussel, Dearman and Thomas,2016). Harris et al. (2016) also posit that “a team is formed based

on the needs of the project to be completed” (p.148). According to Ogrinc et al. (2012), "a team

is not just a group of individuals assembled; teams require proper formation and management”

(p.30). Therefore, to form an inter-professional team required the project implementer to create

an executable work plan which delineates the goals of the project, taking into consideration of

the stakeholders, and defines what role each of the team members will play for the success of the

project. The team formed for the practice change project includes the Project Implementer (PI),

the Director of the Program, the Chief Psychiatrist of the facility, a Doctor of Nurse Practice

Psychiatric Nurse Practitioner (NP), the facility dietician, the facility Information Technology

(IT) personnel coordinator, the units’ therapists and the gym attendant who is in charge of the

facility gym. The gym attendant is a licensed and certified trainer and will be coordinating all the

exercise programs within the gym during the implementation phase.

The program director will be the point person for the execution of various administrative

issues and also liaise with the facility's top management for any direction on the change project.

The chief psychiatrist and the DNP NP will be in charge of checking the progress of the project

and contributing to the ongoing planning and ultimate execution of the project. The dietician will

be the point person who will be involved in dietary strategies education and planning, and also

ensure that the client's participating in the change project receive right portions during the meal

time for dietary management portion of the intervention. The units' therapists will organize and

guide the selected clients during the educational sessions and exercise program and will keep the

record of the participants once they are out of the unit and liaise with project implementer to

confirm such records. The IT personnel will be involved in coordination of data management;

storage and retrieval of protected patients' information after the consent of the patient. The PI

will be the project manager who is involved in the planning and execution of the project. The

plan for collaboration will include ongoing meetings as needed and when scheduled by the team,

conference call and staff updates as the implementation process is being executed.

Risk assessment.

For a successful implementation of a practice change project, it is critical to conduct a risk

assessment in order to provide context and direction for the project. Identifying “strengths,

weaknesses, opportunities and threats” (SWOT analysis) (Harris et al. 2016, p.149) will be used

in collaboration with the team members, taking into consideration all of the stakeholders.

Strengths. The strength of this practice change project is the formation of a motivated

team of inter-professional, who are highly trained and knowledgeable in providing care to

individuals with psychiatric and mental illness in the clinical site. The task of ensuring that this

team works cohesively for the success of the project is through the project implementer (PI)

providing succinct goals and objectives and strategies with a clear timeline, and matching project

tasks to available resources (Harris et al. 2016). A good communication skill is a great asset and

strength of the PI in managing the project process by involving all the stakeholders. The

willingness by the stakeholders particularly, the facility’s director, the agency’s chief executive

officer, the chief psychiatrists and the PI’s preceptor to work closely with the PI for the success

of this project is a great strength and an asset.

Weaknesses.

The weaknesses identified in this practice change project include the challenge of

motivating participants to engage in exercise and dietary strategies to manage weight. Studies

indicate that one of the greatest challenges with weight management in patients with mental

illness, particularly those with schizophrenia, is a lack of motivation to engage in meaningful

physical activities (Manu et al., 2015; Poulin et al., 2007). This is one weakness which will need

to be addressed before and during the implementation process. Another weakness is limited

space in the facility where the participants can engage in warm-up exercises involving walking

and stretching. The space can only accommodate ten participants; therefore, the PI will have to

divide the participants into three groups, which will be time-consuming.

Opportunities.

One opportunity that this practice change project will avail to patients with schizophrenia

is the time to engage in meaning physical activities which will also increase their socialization

skills as well as enhance their moods, thereby improving their effect. Engaging in physical

exercise and dietary strategies will help alter and improve participants' lifestyle from sedentary

status to a more active lifestyle. This is different from the traditional encouragement by the

providers to engage in physical activities, without a follow up of whether such activities are

carried out after the patients leave the program by the end of the day. The positive outcomes

from the change project can be disseminated to other facilities under the umbrella of this agency.

This will be a great opportunity to apply the EBP interventions to help other clients/patients with

the same problem. Another opportunity will be the chance to utilize the facility gym which has

not been utilized in the past and only very few patients use it. This will avail more hours for the

certified gym attendant who is currently underutilized in the facility since not many patients use

the gym.

Threats.

Time management is another weakness which might impact on this project. Working in

this facility, it is evident that clients take their time to move from one task to another and some

may not even follow the instruction due to the disease process. It may, therefore, take time to

mobilize the participants during the changing time from one group to another. Some participants

may want to extend more than the apportioned time, and thus interfere with the time

management during the different shifts of the exercise program. Other weaknesses identified in

the project is the possibility of the participants dropping from the intervention process due to

inability to endure the exercise program, and also some patients choosing dietary strategies and

not exercise. This will be a barrier as well as a treat to the intended outcomes.

Another threat is in the area of funding the upgrade of the gym with additional equipment

and paying the gym attendant for additional hours for the supervision and training of the

participants. Even though the director was promised the funds would be made available, the

timing of the funds may be a threat to the project. Teamwork is vital to the success of change

project implementation. If the goals of the team are not met, this can be another threat which can

adversely affect the outcome of the project.

Strategies to overcome barriers.

Collaboration and proper communication with the stakeholders and all of the team

members (Harris et al. 2016) will be critical in order to minimize any threat of team

cohesiveness. The PI will have to plan and involve all the stakeholders of the timeline of the

implementation and provide clear goals and objective, and strategies for achieving them in the

time allocated for the practice change project. The PI will also have to have regular meetings

with the director of the facility to ensure that all the required funding for the upgrade is done

before the project implementation. For the participants not following instructions, and the

possibility of sustaining injuries, a close supervision by both the PI and the gym certified

attendant will be maintained. Providing bi-weekly reviews and celebrations will encourage the

participants to continue as they share and learn from other participants the success and benefits

of the exercise program and dietary strategies.

Organizational Approval.

The approval process in the organization will involve and include a general consensus of

all of the stakeholders being in agreement with all the major decisions being made for the

purpose of project implementation. Before the implementation, all the team members and

stakeholders will need to compromise on ideas and strategies used in the planning of the project

prior to the start. The project manager will present a detailed planning and implementation

strategies; "considering all the overall aims, goals, outcomes, costs and budgets simultaneously"

(p.148) (Harris et al. 2016). This will help in brainstorming on any issues which may arise as a

barrier or a threat. The site where the change project will be implemented has a director who is

in-charge of the facility. The PI will liaise with the facility director for the organizational

approval.

Information Technology

According to Hebda and Czar (2013), for healthcare professionals to “provide safe,

efficient, quality care,” (p.5), good information technology management will be required in order

to provide necessary resources for the providers to use. Therefore, the information technology

will play a key role in the practice change project in the formation, gathering data, analysis, and

synthesis of the outcomes to determine the success of the project. The information technology

will be used to download important documents, such as informed consent forms to be signed by

the participants, waiver forms, medical clearance forms and fliers to sensitize patients and staff

within the facility about the project goals and objectives. The PI will work in collaboration with

IT personnel to coordinate the safety of data handling and management. The IT personnel will be

in-charge as an honest broker to work on de-identification of participants’ identity in order to

ensure privacy and confidentiality (Hebda & Czar 2013). This process will be important during

the data analysis where the participants’ identity will not be disclosed.

Plans for Institutional Review Board Approval

An expedited type review proposal will be requested from Institutional Review Board

(IRB). The IRB approval will be sought from Chatham University. The project implementation

date will be from May 2018 (See Appendix: A) for IRB proposal.

Materials Needed for Project

The materials needed to implement this project will include the printed shorter version of

Body Shape Questionnaires (BSQ-14) tool, papers, and pencils/pens to conduct the survey. 8X10

sheets of paper will be required to print the BSQ-14 tool, a minimum of 30 copies and a

maximum of 40 depending on the number of participants anticipated based on the census of

patients with schizophrenia on SGAs. Also, approximately 60 handouts will need to be included

to explain the BSQ-14, and its guideline and purposes. In order to recruit candidates for the

practice change project flyers will need to be printed and made available. Approximately 60

flyers will be printed for distribution to patients and staff. Other materials needed are printed

handouts of an educational PowerPoint presentation which will be used to disseminate

information on exercise program and education on dietary strategies. These handouts will be

used in conjunction with PowerPoint presentation in the recreational room where the participants

will be meeting for briefing and educational sessions. About 40 printed copies of the PowerPoint

presentation will be required. Also after the six weeks of the implementation, each participant

will need one self-appraisal form (See Appendix: I), which will assess participants’ motivation

and satisfaction in the exercise program and dietary strategies. A laptop computer with office

2010 program will be needed for the data collection, data storage, preparation for PowerPoints,

preparation of flyers, analysis of data, and computation of the results and expected outcomes. An

external hard drive and or flash drive will be needed to store data and only available to the PI. A

lockable file cabinet will also be needed to store all the surveys collected and only PI will have

access to the key. Finally, a gym equipped with necessary exercise equipment such as five

stationary bicycles, five treadmills, and five stretching mats for warm up before exercise and

warm down at the end of the exercise program. A digital weighing scale will also be part of

equipment needed for weighing participants pre and post-intervention.

Plan for Project Evaluation

Outcomes Measurement.

Harris et al. (2016) described project evaluation as the “effort made to measure the

impact of project-based change” (p.216) and may involve constant evaluation during the

implementation process in order to provide feedback to the stakeholders on how the project is

progressing. For this practice change project there will be two measurable outcomes which will

be evaluated for the success of the project; 1) Weight loss, and 2) enhanced body image

measured through the BSQ-14, which will lead to improved medication adherence, all of which

will contribute to improved overall treatment outcomes.

Weight.

Participants will be weighed during the first week following recruitment to participate in

the practice change project. A digital weighing scale will be used. The weight will be recorded

pre-intervention as (Pre Weight) prior to implementation of the exercise program. At the end of

the sixth week, the participants will be weighed again and weight recorded post intervention as

(Post Weight).

Body Image.

Body image will be measured by the Body Shape Questionnaire-14(BSQ-14). The BSQ-

14 was developed as a modification of the original Body Shape Questionnaire which was 34

items (Dowson and Henderson, 2001). The BSQ-14 has been shown to have a high construct and

convergent validity and also has demonstrated a high reliability with an internal consistency

(Cronbach’s Alpha 0.93) and also high test-retest reliability (Dowson and Henderson, 2001;

Kapstad, Nelson, Overas, and Ro, 2015). The survey has 14 items, which use 1-6-Likert scale:

Never, rarely, sometimes, often, very often and always, and takes about 15minutes to complete

using a pencil/pen. The perception of the body shape which affects the body image will be

compared pre and post intervention (See Appendix: H)

Data Management.

The PI will be responsible for data management and safety in collaboration with IT

personnel. An external hard drive and or flash drive will be needed to store data and only

available to the PI and may be made accessible to IT for the de-identification process during the

data analysis. A lockable file cabinet will also be needed to store all the surveys collected and

only PI will have access to the key.

Data Analysis.

The results from both outcomes pre and post will be reported and analyzed using

descriptive statistics, such as mean and standard deviations. Using the t-test will further look at

the differences between the two groups of means from the two samples. To compare the two pre

and post data, a benchmark score of 30 % decrease in the BSQ-14 (which will assess the body

image outcome), and also 20 % decrease in weight will be set by the PI. If a patient achieves

either of these or both of these benchmarks, the intended outcome(s) will have been met and will

show a positive direction into the weight management or enhancement of body image, with the

eventual improvement in medication adherence as a long-term goal.

Planned implementation steps

Setting.

The practice change project will be implemented in a facility with a population of about

150 patients with varied mental and psychiatric illness. This an outpatient partial day program in

a suburban area of Newark, New Jersey which is partially funded by the state and also a private

agency whose services are for profit. The agency has several other facilities in the northern part

of New Jersey which serve a similar population. This facility will act as the prototype whose

implementation steps will be disseminated to these other facilities as EBP protocols for weight

management.

Population.

For this project, the population will include adults either male or female. The age will be

18 years and older since, in the clinical site where the practice change project will be

implemented, the majority of the patients' ages are in the range of 19 to 65, with less than 20

patients in the senior unit with ages 65 and above. Three patients in the senior unit are above 75

years old. The participating population in this EBP will be individuals whose weight falls within

the BMI > 25 and are patients with schizophrenia being treated with SGAs. Patients with

BMI>25 which falls within overweight range have a higher propensity of becoming obese which

predispose them to increased risks for chronic diseases associated with weight gain and obesity

(Panariello, De Luca, & de Bartolomeis, 2010).

Recruitment.

The individuals will be recruited within the facility. There will be an announcement

being made by units’ leaders to patients regarding the project for those interested. This will be

done after all the units' leaders have been briefed by the PI about the change project, its goals,

and objectives. Flyers will also be distributed explaining the purpose of the practice change

project. The flyers will container a telephone number which the patients can call and get more

information about the specific details on how to proceed with EBP project participation. All

those interested will be given identifier numbers unique to each person for identification to

ensure privacy and confidentiality of the participants. Patients will be selected once they meet

inclusion criteria for weight based on (Body Mass Index) BMI range, and also having

schizophrenia and treated with SGA. The selected patients will also be required to get medical

clearance to participate in physical exercise. Other criteria will be that patient must be free from

other medical problems, such as hypertension, diabetes Mellitus and heart diseases which may be

compromised by physical exercise. This is where the medical clearance will be needed besides

being medically certified to participate in physical exercise. The facility has a medical section

which has a medical doctor and two family nurse practitioners. The PI will provide a medical

clearance form to the medical section of the facility which will be used by the examining medical

doctor or Advanced Practicing Nurse to clear the participants to engage in physical activities

(See Appendix E).

Once an individual is selected, an information letter and a consent form will be provided

to each participant as soon as they meet with the project manager. The units' therapists will assist

in ensuring that the consent forms are duly completed and signed before the patients can

participate in the implementation on May 14th, 2018. Once the implementation starts, there will

be no other participants who will be entering the EBP project.

Implementation Steps

Week one.

The selected participants will sign in on a sheet of paper which will be provided and will

select their three preferred days depending on their schedules on the selected days of the week,

Mondays, Tuesdays, and Thursdays. The participants will have approximately 30 minutes during

the week one in the recreational room to complete pre-intervention survey of BSQ-14 using a

pencil/pen. The participants will also be weighed using an electronic weighing scale for the

baseline weight. The participants will meet between the hours of 11:00 am and 12:00 pm for the

first day. After completing BSQ-14 and also having their weight taken, the subsequent meetings

will be from 10.30am to 12 pm for the second and third day of week one. The BSQ-14 survey

will only be completed during the week one and also in week six. The second day, the

participants will meet in the recreational room and educational sessions on an exercise program

and dietary strategies will be provided for one hour with a fifteen minutes questions and answers

(Q&A) session. This time will be from 10.30am to 11.45am. Participants will then tour the gym

and have a brief introduction by the gym attendant. During the third day, the participants will

have another educational session on exercise and dietary management followed by a Q&A

session for a total of forty-five minutes. During remaining forty-five minutes, the participants

will be introduced to the usage of the equipment in the gym, rules, and regulations, and protocols

of using the gym the gym attendant and the PI.

Week two.

During the second week, the participants will meet three days per week for an hour each

of the days selected. The hour will be divided into 15minutes-30minutes-15 minutes sessions.

The first 15 minutes will be for the warm-up exercise and stretch. This will involve walking on a

specified hallway within the facility for approximately 10 minutes and stretching on training

mats for 5 minutes. This will be followed by 30 minutes of an exercise program in the gym using

a combination of treadmills, stationary bicycles and simple weight lifting using dumbbells under

the direction and supervision of the gym attendant and the PI. The last 15 minutes will be for

cooling down and sharing feedback. At the end of week two, there will be celebration time after

the exercise program where the participants will enjoy a one-hour lunchtime session to share a

bowl of fruits and vegetables as they interact and share their experiences about the change

project progress.

Week 3.

The participants will meet three days of the week for an hour on each of the days

selected. The hour will be divided into 15mins of warm up by walking along the hallways,

followed by half hour of exercise program and 15mins of cooling during which they will receive

a pep talk on dietary strategies and also share feedback about the project goals and objectives for

the week.

Week 4.

The participants will meet three days of the week for an hour each of the days selected.

The hour will be divided into 15minutes-30minutes-15 minutes session similar to weeks two and

three. During the third day of week four, there will be another celebration time after the exercise

program where the participants will enjoy a one-hour lunchtime session to share a bowl of fruits

and vegetables as they interact and share their experiences about the change project progress.

Week 5.

The participants will meet three days of the week for an hour each of the days selected.

The hour will be divided into 15minutes of warm up by walking along the hallway and stretching

on training mats in the gym, followed by 30 minutes of exercise program in the gym, and 15mins

of cooling during which they will receive a pep talk on dietary strategies and also share feedback

about the project goals and objectives for the week.

Week 6.

The participants will meet two days of the week for an hour on each of the days selected.

The hour will be divided into 15minutes of warm up by walking along the hallways, followed by

30minutes of an exercise program in the gym, and 15minutes of cooling down during which they

will receive a pep talk on dietary strategies and also share feedback. During the third day, the

participants will have approximately 30 minutes in the recreational room to complete the post-

intervention survey of BSQ-14 using a pencil/pen. The participants will also be weighed using an

electronic weighing scale for the post-intervention weight. After completing the BSQ-14 survey,

the participants will also complete a self-appraisal form to self-evaluate the exercise program and

the dietary strategies (See Appendix: I). The items in the self-appraisal form will seek to

encourage the client to continue participating in an exercise program and dietary management

post-project time. There will be Q&A session. The team members will also be invited to attend

the session to hear the feedback from the participants as of periodical feedbacks. This will be

followed by celebration time with a healthy lunch for the participants and all the team members

who will be in attendance. The total time commitment requested for the participants in this

change project is approximately 3 hours 45 minutes per week, which will be a total of 22 hours

and 30 minutes for the period of six weeks.

Conclusion

Weight gain and obesity in the United State have become an epidemic. SGA-induced

weight gain and obesity in patients with schizophrenia have become a nationwide epidemic that

lurks in the American population, and also a global problem as well. This leads to other medical

problems such as diabetes mellitus, hypertension, and hyperlipidemia, as well as nonadherence

to medications. In this practice change project, an exercise program and dietary strategies will

be implemented to help patients with schizophrenia manage weight related to SGA.

The facility where the practice change project will be implemented has a high number of

patients with schizophrenia on second-generation antipsychotics. Most of these patients live

alone or with families in the community within a short radius of this facility. The major problem

cited by providers treating these patients is the medication adherence. At the beginning of the

treatment, the patients adhere to the medication regimen and improve greatly within a short

period of time. Consequently, as the patient's cognitive functions improve, the patients become

aware of the serious side effects associated with the use of SGA, which is rapid weight gain and

increasing shift towards obesity (Nielsen et al., 2016; Panariello, De Luca, and de Bartolomeis,

2010). About 75% of these patients often come back to the provider with complaints of

increased weight and a subjective feeling of “being fat.”

Through the implementation of the exercise program and dietary strategies, the expected

outcome will be a decrease in weight for the period of six weeks. This will help to enhance body,

with a resultant increase in medication adherence. A Body Image Questionnaire (BIQ) tool will

be used pre and post-intervention. Participants will also manage a dietary log indicating the type

of foods and portions for the period of six weeks. There will also be biweekly celebrations to

review the progress and also share a simple healthy diet of fruits and vegetables. The post-

intervention weight and results from BSQ-14 will be analyzed using statistical measures in order

to help interpret the outcome of the implementation of the intervention.

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Faulkner, G. (2010). Interventions to reduce weight gain in schizophrenia. Cochrane Database of

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Fenton, W., and Chavez, M. (2006). Medication-induced weight gain and dyslipidemia in a

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Joe, S., & Lee, J. S. (2016). Association between non-compliance with psychiatric treatment and

non-psychiatric service utilization and costs in patients with schizophrenia and related

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Appendix: A

Expedited IRB Proposal

Principal Investigator: Kimani, Joseph, DNP, [email protected]

Faculty EBP project advisor: Dr. Susan Sterrett, EdD, MSN, MBA

Title of Evidence-Based Practice Project: Weight Management for Patients with Schizophrenia

on Second-Generation-Antipsychotic

Funding: Self: $1000 and also funds through the Director of the program at the Clinical Site

Type of research: Evidence-based Practice

Previous or similar IRB project: No

Description of the proposal: Independent Study/Tutorial

Project Narratives

1. The purpose of the proposed project including specific objectives:

This is an evidence-based practice (EBP) change project that is based on the literature

review that strongly supports the use of exercise program and education on dietary strategies to

manage weight gain problem in patients with schizophrenia on SGAs, with the ultimate goal of

improving medication adherence and overall treatment goals in this population. The practice

change project will involve providing education on the modalities of engaging in an exercise

program and dietary strategies as an EBP intervention to improve weight management and

enhance body image in patients with schizophrenia treated with SGAs. Evidenced-based

practice (EBP) need to be the primary method of delivering care in order to guarantee that

uppermost quality of healthcare is provided, while producing the best patient outcomes Melnyk

and Fineout-Overholt, 2015).

Weight gain and obesity are problems prevalent in patients with schizophrenia compared

to the general population. The prevalence of weight gain and obesity in people with

schizophrenia has been reported to be anywhere from 1.5 to 4 times higher than in the general

population (Faulkner, 2010). Even though weight gain and obesity may be a problem for

individuals with schizophrenia before the start of treatment with antipsychotics, studies indicate

that use of second-generation antipsychotics (SGA) leads to significant weight gain in this

population (Manu et al., 2015; Panariello, De Luca, and de Bartolomeis, 2010; Vieweg, and

Hasnain, 2012). Although excess body weight in patients on antipsychotics has been

documented for over 40 years, with 40-80% of such individuals experiencing weight gain

(Maayan, and Corell, 2012), this significant side effect of SGA is particularly problematic in

patients with schizophrenia. Therefore, there is a need to address this problem due to its negative

health implications, such as increased risks for the onset of chronic diseases such as type 2

diabetes mellitus, hypertension and dyslipidemia, which are risk factors for cardiovascular

disorders which affect the quality of life in this population including premature death (Manu et

al., (2015).

In the practice change project the shorter version of Body Shape Questionnaire (BSQ-14)

(Dowson and Henderson, 2001) tool will be used as pre-intervention and post-intervention to

measure the perception of body shape which greatly affects the body image in relation to

weight, followed by EBP implementation of an exercise program and education on dietary

strategies for the purpose of weight management. Findings from several studies indicate that

healthy lifestyle change through exercise and dietary strategies are the interventions of choice

to help with weight management in patients with schizophrenia on SGAs (Faulkner, Cohn, and

Remington, 2010; Manu et al., 2015; Poulin et al., 2007; Usher, Park, Foster, and Buettner,

2013). Faulkner, Cohn, and Remington (2010) conducted a systematic review of randomized

controlled trials (RTCs) to determine the effects of both pharmacological (excluding

medication switching) and non-pharmacological strategies for reducing weight gain in patients

with schizophrenia. The authors reported that there was significantly greater weight reduction

in the cognitive behavioral interventions group involving lifestyle changes (n=129, 3RCTs,

weighted mean difference (WMD) -1.69kg, fixed 95% CI[ -2.8 TO -0.6]) compared with

standard care, while no significant change in weight reduction was found with pharmacological

intervention(n=112, WMD, -0.27, fixed 95% CI [-2.2 to 1.6]). Faulkner, Cohn, and

Remington (2010) concluded that initiating and maintaining a low-cost exercise program and

discussions on healthy eating as a healthy lifestyle change had a better outcome in weight

management compared to pharmacological interventions for patients with schizophrenia on

SGAs.

Manu et al. (2015) conducted a meta-analysis of RCTs published between 2005 and

2014. The authors reported that following behavioral interventions of exercise and dietary

management in 810 patients in the meta-analysis, the results indicated a significant reduction in

weight (-3.13kg; BMI (-0.94kg/m²), waist circumference (-3,6cm) and body fat (-2.82%). The

authors concluded that intensive lifestyle interventions with increased physical activity involving

walking 2-3 times per week for 30minutes, with endurance activities and, adherence to diet

management of reduced caloric intake, the amount of weight loss was enhanced and maintained.

Usher, Park, Foster, and Buettner, (2013) conducted an experimental randomized control

trial on 104 participants (mean BMI of 33.71kg/m²) with schizophrenia (84.2%) and other mental

disorders (15.8%), to measure weight loss and medication compliance. The authors concluded

that multi-modal approaches which include a combination of education, healthy lifestyle,

behavioral, and exercise intervention with diet strategies are more likely to be effective in

reducing weight in the longer term than any of the interventions on their own.

In another study by Poulin et al. (2007), the authors conducted a prospective,

comparative, open and naturalistic; a descriptive and qualitative study and concluded that body

weight and metabolic risk profile in patients with schizophrenia receiving SGAs can be managed

with a weight control program including physical activity. Dietary strategies were not included in

this study. Therefore, these studies indicate that there is a strong EBP research to support healthy

lifestyle changes through exercise program and education on dietary strategies as an efficacious

intervention to manage weight gain in patients with schizophrenia on SGA.

These outcomes will contribute to improved overall treatment outcomes, with other

benefits tied to these outcomes, such as increased knowledge for weight management, improved

mental well-being, improved sleep, and decreased risks for the chronic diseases. The outcome

measures with BSQ-14 will display an improvement in body image which has a direct

relationship to decreased weight. Therefore, the purpose of this change project is to delineate the

exercise program and education on dietary strategies as evidence-based practice interventions

which will address the weight and obesity problem in patients with schizophrenia on SGA. This

EBP change project is to help patients with schizophrenia on second-generation antipsychotics

(SGA) manage weight, leading to weight loss, which will enhance their body image, and

ultimately lead to an improved medication adherence.

References

Dowson, J., and Henderson, L. (2001). The validity of a short version of the Body Shape

Questionnaire. Psychiatry Research, 102(1), 263-271. Retrieved from

http://ezproxy.chatham.edu:2127/science/article/pii/S0165178101002542