Clinical trial NCT04068493: A Dissonance-Based Obesity Intervention
Official title: Enhanced Project Health: A Dissonance-Based Intervention for Obesity in Young Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of eligible young adults that agree to participate in the study
timeFrame: Up to 1 month
measure: Time for recruitment
timeFrame: Up to 1 month
measure: Attendance rate of participants
timeFrame: Assessed at 2 months
measure: Retention rate of participants
timeFrame: Assessed at 2 months
measure: Program Evaluation Questionnaire - Each Group Session
timeFrame: Assessed from week 1 to week 8
measure: Program Evaluation Questionnaire - Overall Program
timeFrame: Assessed at week 8
Secondary outcomes:
measure: Body Mass Index (kg/m^2)
timeFrame: Baseline to 2 months
measure: International Physical Activity Questionnaire-Short Form (IPAQ-S)
timeFrame: Baseline to 2 months
measure: Actigraph GT3XP-BTLE
timeFrame: Baseline to 2 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to 2 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Neuropsychiatric Institute, University of Illinoist at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sylvia Herbozo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: