A Dissonance-Based Obesity Intervention

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04068493
• Other study ID #: 2019-0892
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 18, 2022

Study information

• Verified date: June 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Young adults of ages 18 to 25.

2. Enrolled as a college student.

3. Body mass index of 25 or more (overweight/obese) based on measured height and weight.

Exclusion Criteria:

1. Diagnosis of bulimia nervosa according to DSM-5 criteria.

2. Diagnosis of obstructive sleep apnea.

3. Participation in interventions for weight loss or disordered eating behaviors.

4. Current use of prescription drugs for weight loss or disordered eating behaviors.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Enhanced Project Health
A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).

Locations

Country	Name	City	State
United States	Neuropsychiatric Institute, University of Illinoist at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of eligible young adults that agree to participate in the study	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
Primary	Time for recruitment	This will be defined as time (weeks and days) from initial contact with research staff to randomization into the study.	Up to 1 month
Primary	Attendance rate of participants	This will be defined as the percentage of participants attending 75% of the group sessions.	Assessed at 2 months
Primary	Retention rate of participants	This will be defined as the percentage of participants remaining in the study at the post-intervention assessment.	Assessed at 2 months
Primary	Program Evaluation Questionnaire - Each Group Session	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
Primary	Program Evaluation Questionnaire - Overall Program	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
Secondary	Body Mass Index (kg/m^2)	Body Mass Index will be calculated using measured weight and height (kg/m^2)	Baseline to 2 months
Secondary	International Physical Activity Questionnaire-Short Form (IPAQ-S)	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
Secondary	Actigraph GT3XP-BTLE	An accelerometer will record physical activity for a 1 week period	Baseline to 2 months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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