A Dissonance-Based Obesity Intervention
Enhanced Project Health: A Dissonance-Based Intervention for Obesity in Young Adults
研究概览
详细说明
Approximately 34% of college students are overweight/obese. However, few behavioral weight loss (BWL) interventions have been developed for young adults in college. Research suggests that standard BWL interventions are not addressing the needs of young adults as they have shown poorer retention rates and weight loss compared to older adults in BWL trials. Standard BWL interventions are also time-intensive and are not conducive to inexpensive dissemination.
The primary aim of this project is to examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention for young adults enrolled in college. Enhanced Project Health is based on Project Health, a dissonance-based obesity prevention program, which has been shown to significantly decrease weight gain and future overweight/obesity onset compared to a matched intervention and minimal intervention control condition in young adults. The current intervention was expanded to consist of eight weekly group sessions and to address sleep, in addition to diet and physical activity. The secondary aim is to test the hypothesis that Enhanced Project Health will result in significantly greater reductions in weight and improvements in lifestyle behaviors compared to an assessment only condition.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、606012
- Neuropsychiatric Institute, University of Illinoist at Chicago
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Young adults of ages 18 to 25.
- Enrolled as a college student.
- Body mass index of 25 or more (overweight/obese) based on measured height and weight.
Exclusion Criteria:
- Diagnosis of bulimia nervosa according to DSM-5 criteria.
- Diagnosis of obstructive sleep apnea.
- Participation in interventions for weight loss or disordered eating behaviors.
- Current use of prescription drugs for weight loss or disordered eating behaviors.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dissonance-based obesity intervention
Participants in this arm will receive Enhanced Project Health.
|
A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).
|
|
无干预：Assessment Only
Participants in this arm will only complete the baseline assessment and 2 month assessment.
They will not receive Enhanced Project Health.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of eligible young adults that agree to participate in the study
大体时间：Up to 1 month
|
This will be defined as a percentage of young adults that agree to participate in study out of the young adults screened for the study.
|
Up to 1 month
|
|
Time for recruitment
大体时间：Up to 1 month
|
This will be defined as time (weeks and days) from initial contact with research staff to randomization into the study.
|
Up to 1 month
|
|
Attendance rate of participants
大体时间：Assessed at 2 months
|
This will be defined as the percentage of participants attending 75% of the group sessions.
|
Assessed at 2 months
|
|
Retention rate of participants
大体时间：Assessed at 2 months
|
This will be defined as the percentage of participants remaining in the study at the post-intervention assessment.
|
Assessed at 2 months
|
|
Program Evaluation Questionnaire - Each Group Session
大体时间：Assessed from week 1 to week 8
|
This questionnaire was developed for this study. It will assess the acceptability of the intervention and will be administered at the end of each group session. Participants will be asked to rate the usefulness of the session on one item with a scale ranging from 1 to 5. Total scores range from 1 to 5. Higher scores indicate more usefulness. Participants will also be asked to respond to open-ended questions about each group session. These questions will assess the most favorable aspects, least favorable aspects, and areas of improvements. Responses will be coded using a variation of the long table approach emphasizing frequency, specificity, emotion, and extensiveness. Codes will be examined to identify themes. |
Assessed from week 1 to week 8
|
|
Program Evaluation Questionnaire - Overall Program
大体时间：Assessed at week 8
|
This questionnaire was developed for this study.
It will assess the program with regard to effectiveness and satisfaction as well as characteristics of the group leaders (clarity, knowledge, experience, respect) using a scale ranging from 1 to 5. Total scores range from 8 to 40.
Higher scores indicate more favorable responses.
This questionnaire will be administered at the end of the last group session.
|
Assessed at week 8
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Mass Index (kg/m^2)
大体时间：Baseline to 2 months
|
Body Mass Index will be calculated using measured weight and height (kg/m^2)
|
Baseline to 2 months
|
|
International Physical Activity Questionnaire-Short Form (IPAQ-S)
大体时间：Baseline to 2 months
|
The International Physical Activity Questionnaire-Short Form will assess walking, moderate-intensity activity, and vigorous-intensity activity.
The scores for each type of physical activity are converted to MET-minutes/week as defined by the following: Walking MET-minutes/week = 3.3 * walking minutes * walking days; Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days; Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days; Total physical activity MET-minutes/week = sum of Walking + Moderate + Vigorous MET-minutes/week scores.
The total score will be computed by summing the duration (in minutes) and frequency (days) of each activity.
Higher duration and frequency indicate more engagement in physical activity.
The pattern of physical activity can also be classified as low, moderate, or high based on the total score.
|
Baseline to 2 months
|
|
Actigraph GT3XP-BTLE
大体时间：Baseline to 2 months
|
An accelerometer will record physical activity for a 1 week period
|
Baseline to 2 months
|
|
Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline to 2 months
|
The Pittsburgh Sleep Quality Index will assess the quality and patterns of sleep using a scale ranging from 0 to 3. Total scores range from 8 to 57.
Higher scores indicate greater sleep disturbances.
|
Baseline to 2 months
|
合作者和调查者
调查人员
- 首席研究员：Sylvia Herbozo, Ph.D.、University of Illinois at Chicago
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Enhanced Project Health的临床试验
-
University of MichiganNational Institute of Mental Health (NIMH)完全的
-
London School of Hygiene and Tropical MedicineChildren's Investment Fund Foundation; Splash完全的
-
University of North Carolina, Chapel HillCenters for Disease Control and Prevention完全的