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Phase 1 N=10 Supportive Care

Weight Management Program for Patients With First Episode Psychosis

Diet, Healthy · Psychotic Disorders

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Weight — -6; -3; -5; -4 Lbs

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Family Based weight management program (Behavioral)
Age
Pediatric, Adult · 14+ yrs
Sex
All
Sponsor
State University of New York at Buffalo
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Weight
-6; -3; -5; -4; 11; 5

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.

Eligibility Criteria

Inclusion Criteria

Participant:

  • Age 14-26 years
  • Enrolled in NAVIGATE, a clinical program for patients with first episode of psychosis.
  • Prescribed antipsychotic medication for a first break psychotic episode
  • Availability of household family member to collaborate in the weight management program.

Family Member:

  • Lives in the same household as participant (e.g., parent, guardian, grandparent, aunt or uncle)
  • Able to attend weekly meetings with a case manager

Exclusion Criteria

Participant & Family Member:

  • Personal or Family history or evidence of current eating disorders (bulimia or anorexia or binge eating disorder)
  • Current alcohol or drug abuse,
  • Unable to read at 8th grade level
  • Unable to use technology.
  • Unable to weigh themselves daily due to existing medical condition
  • Pregnant or planning on becoming pregnant during the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05207982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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