Weight Management Program for Patients With First Episode Psychosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
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:
- Recruit and provide FBT to 12 FEP patients and their parents using a multiple baseline single case experimental design;
- Evaluate participation, attrition, and satisfaction of the patients and their families across the three month treatment period;
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 26 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Weight
时间窗: 7 months
Change in weight will be assessed at baseline, weekly during study period, end point, and follow up.
次要结局
未报告次要终点
研究者
Daniel Antonius
Associate Professor
State University of New York at Buffalo
