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临床试验/NCT04068493
NCT04068493终止不适用

Enhanced Project Health: A Dissonance-Based Intervention for Obesity in Young Adults

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
2
主要终点
Percentage of eligible young adults that agree to participate in the study

研究概览

简要总结

This project will examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention, and whether this intervention results in significantly greater reductions in weight and improvements in lifestyle behaviors than an assessment only condition. Participants will be young adults enrolled in college.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will be blind to the condition that participants are assigned to.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Young adults of ages 18 to
  • Enrolled as a college student.
  • Body mass index of 25 or more (overweight/obese) based on measured height and weight.

排除标准

  • 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.

结局指标

主要结局

Percentage of eligible young adults that agree to participate in the study

时间窗: 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.

Program Evaluation Questionnaire - Overall Program

时间窗: 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.

Time for recruitment

时间窗: Up to 1 month

This will be defined as time (weeks and days) from initial contact with research staff to randomization into the study.

Attendance rate of participants

时间窗: Assessed at 2 months

This will be defined as the percentage of participants attending 75% of the group sessions.

Retention rate of participants

时间窗: Assessed at 2 months

This will be defined as the percentage of participants remaining in the study at the post-intervention assessment.

Program Evaluation Questionnaire - Each Group Session

时间窗: 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.

次要结局

  • Body Mass Index (kg/m^2)(Baseline to 2 months)
  • International Physical Activity Questionnaire-Short Form (IPAQ-S)(Baseline to 2 months)
  • Actigraph GT3XP-BTLE(Baseline to 2 months)
  • Pittsburgh Sleep Quality Index (PSQI)(Baseline to 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvia Herbozo

Associate Professor

University of Illinois at Chicago

研究点 (2)

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