The International Journal of Psychosocial Rehabilitation
Second Generation Neuroleptic Weight Gain:
Evaluating Early Intervention Strategies –
A Feasibility Study

 Donna E. Tweedell, RN, MSN, CPRP
Assistant Clinical Professor, School of Nursing, McMaster University

 Angelica Sutter RN(EC), BScN, PHCNP, CPMHN(c)
Nurse Practitioner, St. Joseph's Healthcare Hamilton

 Saundra Dunphy, BASc(Hon), RD
Clinical Dietitian, St. Joseph’s Healthcare Hamilton

 Janet Landeen, RN, PhD
Nurse Practitioner, St. Joseph's Healthcare Hamilton

  Citation:
Tweedell D.E.,  Sutter A., Dunphy S.,  & Landeen J.(2004).  Second Generation Neuroleptic Weight Gain:Evaluating Early
 Intervention Strategies – A Feasibility Study.    International Journal of Psychosocial Rehabilitation. 9,41-46.

Corresponding author:  
Donna Tweedell
Family Nursing Consultants
32 Chedoke Avenue
Hamilton, Ontario  L8P 4N9
CANADA
Email:  tweedell@mcmaster.ca


Acknowledgments:
This study was supported by Eli Lilly (Zyprexa Research Fund) #F1D-CA-O142, Novartis Pharma Canada Inc., the Father Sean O’Sullivan Research Centre of St. Joseph’s Healthcare Hamilton, the Hamilton Chapter-Schizophrenia Society of Ontario, and the Volunteer Association of the former Hamilton Psychiatric Hospital.

Presented as a poster at “The Art, the Science, and the Ethics of Psychiatric and Mental Health Nursing”, Canadian Federation of Mental Health Nurses, Toronto, Ontario, October 30 – November 1, 2003.

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Abstract
Objective:  This case series study evaluated the feasibility of a six-month weight prevention program, involving nutritional counseling and an individualized exercise program monitored by a personal fitness trainer, for individuals with serious mental illness.
Methods:  Fourteen adults with a serious mental illness, who were inpatients at a specialized tertiary care psychiatric facility, entered the study.  All had begun taking a second generation neuroleptic within the previous four months and were overweight.  Primary outcome measures included weight, waist-hip ratio, and body mass index.  Secondary outcome measures included several diet and fitness instruments.  Data were collected at baseline, three and six months.
Results:  Six individuals fully completed the program and eight dropped out.  There were no statistically significant differences on any measures.  Although there were no statistically significant differences between the dropouts and the completers on age, duration of illness, or initial weight or BMI, the older age of the completers neared statistical significance.  The completers experienced a variety of interruptions, which caused them to disengage temporarily from the study.  Follow-up at one year indicated that all six subjects were involved in some form of physical activity on a regular basis.Conclusions:  This study highlights the challenges of weight prevention and lifestyle change in this population and suggests directions for further research.

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Introduction
Weight gain has been a side effect of many antipsychotic medications.  While the newer second generation antipsychotics offer advantages over conventional neuroleptics in the treatment of schizophrenia and mood disorders, weight gain remains a problem (Taylor & McAskill, 2000).  Anecdotally, evidence suggests that antipsychotic-induced weight gain increases the risk of medication nonadherence, and thus the return of psychotic symptoms.  Weight gain associated with second generation antipsychotics has been particularly linked to glucose intolerance and non-insulin-dependent diabetes mellitus (NIDDM) (McIntyre, McCann, & Kennedy, 2001).  Despite recommendations for early interventions to prevent weight gain in this population (McIntyre et al., 2001; Baptista, 1999), research has been sparse.  One recent study reported that a 12-week weight control program incorporating exercise, dietary, and behavioural interventions is feasible and effective with this population (Vreeland et al., 2003).  However, the gold standard of the effectiveness of weight loss programs indicate that interventions should be of at least 6 months duration to determine if they are truly effective in maintaining the desired outcomes (Committee to Develop Criteria for Evaluating the Outcomes of Approaches to Prevent and Treat Obesity, 1995).

We conducted three discussion groups with individuals living in the community on second generation antipsychotics who had maintained or lost weight.  Based on their recommendations (reported elsewhere) we developed an intervention to prevent weight gain for the inpatient population of a specialized tertiary care psychiatric facility in south central Ontario.  The purpose of this study was to address the following research questions:

1) Is an early weight prevention program feasible with this population?

2) What changes occur in the participants over the course of the study?

The weight prevention program consisted of dietary counseling with a registered dietitian and an individualized exercise program.  To address the unique challenges of our population, a personal trainer provided ongoing, individualized support and motivation to participants in the exercise program.  Participants met with the personal trainer at the hospital gym or at a YMCA.  Both the dietitian and the fitness trainer continued to provide support and encouragement when participants were discharged from hospital.

Methods
This case series feasibility study used the following outcome measures at baseline, three, and six months.  Primary outcome measures included weight, waist-hip ratio, and body mass index (BMI).  Secondary measures were a 24-hour dietary recall, the Food Frequency Questionnaire (Block et al., 1986; Advisory Committee on the Dietary Guidelines for Americans, 1995), the Rockport VO2 Max Walking Test, and a number of cardiac fitness, strength and flexibility tests (Cotton, 1997).  Demographic information and measures of fasting blood sugar level and fasting lipid profile were also completed.  The dietitian, personal trainers, and the research assistant kept anecdotal records regarding feasibility issues.

All subjects were new starts on second generation antipsychotics ie. Clozapine, Olanzapine, Risperidone, or Quetiapine.  Additional inclusion criteria were:  a diagnosis of schizophrenia, schizo-affective or bipolar affective disorder; 18 to 55 years old; BMI < 27; medically cleared to participate in an exercise program; and able to comprehend English.  Exclusion criteria were:  on a second generation antipsychotic > one month; on multiple neuroleptics; BMI > 27; a DSM IV diagnosis of an eating disorder, drug/alcohol related psychosis, or mania; diagnosis of a major medical illness; an abnormal electrocardiogram; pregnancy; or current enrolment in a fitness program.  Approval was obtained for this study from the ethics review board of the participating institution and all participants provided informed consent.  

Results
Feasibility.  Subjects were recruited from a population of 160 potential subjects who were taking one of the target medications.  These included 96 men and 64 women, whose ages ranged from 18 to 55 and whose BMIs ranged from 19.4 to 66.8 kg/m².  Of this group, 37% were diagnosed with schizophrenia, 11% with major depressive disorder, 13% with dual diagnoses, and the remainder had complex, multiple diagnoses.  Subjects were recruited from April 2001 to November 2002.  Nineteen individuals were eligible for our study.  Five declined to participate:  two were too ill to commit, one declined traveling the distance once discharged, and two were not interested.  Twelve months into the study, we amended inclusion criteria to include patients who had been on a second generation antipsychotic for up to one year, and had a BMI of up to 30.  When we had initially designed this research, many of the potential subjects had just started taking second generation antipsychotics.  However, by the time we began the study, very few individuals were eligible using our original inclusion criteria, as many had been on the medications longer than one month.  Other reasons for exclusion included initial medication nonadherence with repeated restarts, concurrent substance abuse, BMI over 30, or presence of physical conditions such as diabetes or neurological disorders.

Fourteen individuals, who were all in-patients at the tertiary care hospital at recruitment, entered the study.  Fifty seven percent (n=8) was male, 43% (n=6) was female.  Marital status was: 71.5% (n=10) single, 21.5% (n=3) separated or divorced, and 7% (n=1) married.  Following discharge from hospital, six individuals (43%) were living with their family of origin, seven (50%) were living in supported housing with meals provided, and one was living independently.
Six individuals completed the full six months of the intervention and all outcome measures.  However, three experienced interruptions due to physical illness or injury, one experienced disruption due to an increase in symptoms, one needed to take time out to focus on family, and one temporarily disengaged from the study during discharge from hospital.

Of the eight individuals who dropped out, the average number of days of participation was 56.5, with a standard deviation of 26.28, and a range of 30 to 100 days.  Reasons for withdrawal included:  ceasing to take one of the study medications; being discharged outside the region of the facility; having a treatment conflict; and being non-adherent and using illicit substances.  There were no statistically significant differences between the drop-outs and the completers on age, duration of illness, or initial weight or BMI, although the older age of the completers neared statistical significance using t-test for analysis (see Table 1).



Observations by the dietitian and personal trainers highlighted some issues related to participation in the intervention.  The nature of the relationships between the subjects and the clinicians influenced the subjects’ commitment to the program, including remaining in the study.  While the subjects were in the controlled hospital environment, adherence to all aspects of the intervention was easier.  The personal trainers were based in the hospital, which facilitated initial rapport building.  All subjects experienced difficulty adhering to physical activity programs in the weeks immediately following discharge.  Contact with the clinicians after discharge tended to become more sporadic.  The personal trainers and dietitian had to actively develop strategies to overcome communication challenges.  Six months to one year following completion of the intervention, subjects reported that they continued with some form of physical activity.

The experience with the various measurement tools was a mixture of benefits and challenges.  With the Food Frequency Questionnaire and the 24 hour dietary recall, subjects were required to remember what they had eaten.  Items may often have been missed, which may have reduced the accuracy of the data.  However, the use of food models was helpful in assisting participants to visualize foods and in accurately showing food amounts.  Outside of the controlled environment of the hospital, subjects’ dietary patterns were more difficult to assess.  Several subjects displayed increased anxiety prior to formalized fitness tests.  The location of the fitness testing presented a challenge for some subjects.

Changes in Subjects.  All completers remained on their prescribed medication for the duration of the study.  Repeated measures ANOVA were used to compare outcomes in the primary outcome variables (weight and BMI) and the lifestyle or dietary outcome variables (total calories, carbohydrates, proteins, and fats consumed daily).  There were no statistically significant differences on any measures over time, indicating that the participants did not significantly increase in their weight or BMI over the course of the six months of the study (See Table 2).

Table 2 Comparisons of Outcome Measures over Time using Repeated Measures ANOVA

 

Discussion and conclusions
On average, there was a 7.6 kg weight gain over six months.  Most of the weight gain occurred in the first three months.  While not statistically significant, the likelihood of a type II statistical error is high, given the extremely small sample size.  Although the purpose of this study was one of feasibility, rather than a comparison over time, it is interesting to note that while some weight gain occurred, the reported total daily calories consumed decreased.  Either there were flaws in the dietary assessment, or the weight gain was not directly related to an increase in caloric intake.

Our results highlight the challenges of implementing a weight gain prevention program for individuals with severe mental illness who are beginning second generation antipsychotics.  Given that lifestyle changes are difficult even for the regular population, we acknowledge the immense challenges faced by individuals with severe mental illness who undertake such commitments.  The difficulties we experienced in recruiting individuals for this study may in part reflect these challenges.  Recruitment was a struggle due to the need to accommodate staff rotation.  For individuals who entered the study, a variety of factors—including physical illness, discontinuation of medication, family priorities, and relocation after discharge—intervened in and delayed study participation.  In particular, subjects’ participation in the study consistently waned after discharge, as the immediate needs of making the transition to living in the community took precedence.  Our experience suggests that allowing a period of recovery once an individual has started on the medication may improve commitment to healthy lifestyle changes.  It was notable that our recruitment flyer drew many requests from interested outpatient young men and middle-aged women who had been on their medications for one year or longer.  The relative cost of healthy food choices given a limited budget may have resulted in consumption of less expensive empty calories.  Given the discrepancy between weight gain and reported total calories consumed, dietary recall may be especially challenging in this population.  Daily contact with the dietitian might have ensured greater compliance with and accuracy of the nutritional measures.  The commitment to make lifestyle changes may also be facilitated by support provided by a full-time, mobile fitness trainer. 

Our feasibility study indicates that more research on diet and exercise interventions with this population is needed.  The focus of this research needs to expand from weight prevention to include healthy weight management after significant weight gain has occurred.

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