CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Family Based weight management programbehavioral
Likely dose
Not stated in record
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Search/NCT05207982
NCT05207982Phase 1Completed

Weight Management Program for Patients With First Episode Psychosis

State University of New York at Buffalo·interventional·Posted Jan 26, 2022·Updated Jan 14, 2025

In Brief

A Phase 1 clinical trial evaluating Family Based weight management program for Diet, Healthy and Psychotic Disorders. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJan 26, 2022
Enrollment StartJul 15, 2022
Primary CompletionMay 21, 2023
Study CompletionJul 5, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.4 years ago

Interventions

Family Based weight management programbehavioral

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.