Weight Management Program for Patients With First Episode Psychosis
Condition: Diet, Healthy; Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Severe mental illnesses (SMI), such as schizophrenia, are associated with increased morbidity
      and mortality in large part due to obesity and concomitant metabolic disorders. People with
      SMI have twice the risk of becoming obese, driven by the use of antipsychotic medications.
      These antipsychotic medications are dopamine antagonists, which reduce brain dopamine levels,
      leading to an increase in food reinforcement, which leads to weight gain. This weight gain
      occurs very rapidly with the initiation of these medications, as do increases in LDL
      cholesterol, insulin, and leptin.

      While there have been attempts to develop weight loss programs, a recent meta-analysis
      concluded that these interventions led to statistically significant weight loss that was of
      no clinical significance and did not last beyond the intervention. Given the rapid weight
      gain/metabolic changes and the findings that it is easier to prevent weight gain than to lose
      weight, interventions targeting the early phases of a first episode of psychosis (FEP) are
      critical. However, the very few attempts have failed to address two key aspects of first
      episode psychosis. First, antipsychotic medications increase the reinforcing value of food
      and interventions have not included strategies to provide alternative reinforcements. Second,
      most patients experiencing FEP live with and are dependent on their parents, but existing
      interventions have not utilized parents in support of exercise and dietary changes.

      The purpose of this project is to assess the feasibility and acceptability of, and to provide
      preliminary evidence for the efficacy of a Family-Based Treatment (FBT) that includes both
      the patient and the parent in the intervention and provides structured help in developing
      alternative reinforcements that support exercise and dietary changes. The specific aims of
      this project are:

        1. Recruit and provide FBT to 12 FEP patients and their parents using a multiple baseline
           single case experimental design;

        2. Evaluate participation, attrition, and satisfaction of the patients and their families
           across the three month treatment period;

        3. Examine the hypothesis that weight and food reinforcement will be significantly reduced
           during the treatment and follow-up phases in contrast to the baseline period.
    

Detailed description: 
      C. Overview Study Sample: Twelve families will be recruited from NAVIGATE, a program for
      first episode psychosis patients. Patients in the program and who have been prescribed
      antipsychotic medications will be eligible. In addition, to be eligible, one of the parents
      must agree to work with the patient, and agree to modify their eating, exercise and if obese,
      their own weight. Patients and parents must be able to read at the 8th grade level. Patients
      or parents with a history or evidence of current eating disorders (bulimia or anorexia or
      binge eating disorder) or a current alcohol or drug use disorder will be excluded.

      The NAVIGATE program admits 2 to 3 patients per month. At the beginning of the study, we
      anticipate that there would be approximately 40-45 patients in the program with the requisite
      use of antipsychotic medications, and over the next five months, we would expect an
      additional 10-15 patients. Assuming that 50% of the patients are eligible and interested, we
      would have approximately 25-30 patients available for the study.

      Assessments: Participants will have a baseline session in which they complete the Behavioral
      Choice Questionnaire that assesses the reinforcing value of food. Parents and the patients
      will also complete questionnaires regarding parenting, time perspective, consideration of
      future consequences, and have their height and weight measured. Following the baseline
      assessment, baseline data will be collected over a two month period, and then families will
      be randomized to staggered initiation of treatment in blocks of 4 families. At the end of
      treatment, the patient and the participating parent will receive the same assessment battery
      that they completed for the baseline session. They will also provide information on the
      implementation of the diet, exercise, and alternative reinforcement procedures. After an
      additional 2 months, the patient and parent will return for the final assessment using the
      same assessment battery, as well as the implementation data.

      During the baseline, treatment and follow-up period, patients will take their weight daily
      with a Bluetooth scale provided by the project.

      Intervention: Families will receive a 12-week FBT adapted for first episode psychosis. This
      will be delivered in 12 weekly meetings with a trained case manager and two "eating plan"
      education sessions. Both the patient with psychosis and parents are targeted for eating and
      activity/exercise change to ensure a change in the shared family environment, which will also
      help weight control in both sets of participants, as well as medical issues that accompany
      obesity, including glycemic control, hypertension and hyperlipidemia. If parents are not
      overweight/obese, they will still target improved health behaviors. They will learn about
      GREEN, YELLOW, and RED foods (healthy vs. unhealthy foods), energy density, glycemic index of
      foods, reducing serving sizes, eating less, healthy lifestyle and programmed activity
      programs and recording their diets and activity. Weekly sessions will involve discussion of
      weight loss principles presented in modules in the weight control manual, and coaching
      parents and patients how to implement the Traffic Light Eating Plan and healthy lifestyle
      techniques. At each session, participants meet with staff and attend a brief problem solving
      session with their case manager where they will troubleshoot any expected or encountered
      issues with implementing the program. As part of treatment, participants will weigh
      themselves daily with a Bluetooth scale.

      An innovative aspect of this treatment is helping patients develop alternative reinforcements
      that do not involve food that can reduce the motivation to eat for the hedonic or reinforcing
      motivations. The first step is to identify alternative activities that have a higher
      reinforcement value than the patients' favorite foods. First, participants will identify
      potential alternatives from the 139 behaviors on the Pleasant Activities List. The therapist
      then works with the patient to better specify the behavior, ensure its feasibility and
      describe the parameters of the behavior (e.g. duration). After the participant and case
      manager agree on a list of alternatives (at least 5), the participant will complete the
      Behavioral Choice Questionnaire that assesses the reinforcing value of that activity in
      comparison to food. The most reinforcing food to be used to assess behavioral substitutes
      will be chosen from a list of usual meals that can be obtained from home cooked, fast food or
      casual dining restaurants. These alternative reinforcements are used non-contingently by the
      patients/parents to provide highly desirable activities that compete with excessive food
      consumption.

      Design and analysis: The project is a multiple baseline single case experimental design, with
      a 2 month baseline data collection. Families will then be randomized to staggered initiation
      of treatment in blocks of 4 families. We anticipate having 8 participating families at the
      beginning of the project and would randomly assign them to start the baseline assessment
      between 1 and 9 weeks into the project, with the treatment then beginning between weeks 9 and
      17. Treatment completion for this initial cohort would be between weeks 21 and 29, and the
      final follow-up would occur between weeks 29 and 37. Families entering NAVIGATE after the
      recruitment of the first cohort will be randomly assigned to start the baseline from 1 to 9
      weeks after entry. This will provide a significant baseline (2 months) for all participants
      with different initial points for the study.

      Analysis of the daily weights will involve discontinuous growth curve analysis using
      multi-level modeling. Separate models are developed for each participant which include the
      daily weights from the baseline (60 days), treatment (90 days) and follow-up (60 days)
      phases. Given the nature of the data, we would hypothesize significantly different slopes for
      the baseline vs treatment phases. We would also expect no significant differences between the
      slopes for the treatment phase and the follow-up phase. The primary analysis involves
      modeling each individual as a level one variable. This data may be examined at the individual
      level to provide information regarding the number of individuals responding to the treatment,
      as well as through meta-analysis to provide more specific effect sizes.
    

Intervention name(s): Family Based weight management program
Intervention type(s): Behavioral
Intervention description(s): Weight management program that involve the patient AND a family member or a care taker. Families will receive a 12-week FBT adapted for first episode psychosis. This will be delivered in 12 weekly meetings with a trained case manager and two "eating plan" education sessions. Both the patient with psychosis and parents are targeted for eating and activity/exercise change to ensure a change in the shared family environment, which will also help weight control in both sets of participants, as well as medical issues that accompany obesity, including glycemic control, hypertension and hyperlipidemia. If parents are not overweight/obese, they will still target improved health behaviors. They will learn about GREEN, YELLOW, and RED foods (healthy vs. unhealthy foods), energy density, glycemic index of foods, reducing serving sizes, eating less, healthy lifestyle and programmed activity programs and recording their diets and activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care