Effectiveness Trial of a Dissonance-Based Obesity Prevention Program

NCT ID: NCT01680224

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-01
• Study Completion Date: 2018-05-31

Brief Summary

Obesity is a major US public health problem. Few obesity prevention programs have reduced risk for weight gain over follow-up and those that have are very intensive, making dissemination difficult and costly. A brief 3-hr selective prevention program (Healthy Weight) targeting young adults with body dissatisfaction involving participant-driven healthy dietary and physical activity lifestyle changes significantly reduced increases in body mass index (BMI) and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up, though effects were small in magnitude. To enhance efficacy, the investigators added dissonance-inducing activities regarding unhealthy dietary and activity practices, drawing from a highly efficacious dissonance-based eating disorder prevention program. A pilot trial found that this new Project Health intervention significantly reduced increases in BMI relative to both the Healthy Weight intervention and an educational brochure condition from pre to post. The investigators propose to conduct a rigorous multisite effectiveness trial that will test whether adding the dissonance-induction elements to the originally Healthy Weight intervention improves weight gain prevention effects. 360 college students at risk for future weight by virtue of their age and weight concerns will be randomized one of three conditions: (1) a refined 6-hr group-based dissonance-based Project Health, (2) a 6-hr group-based Healthy Weight intervention, or (3) a psychoeducational video ("Weight of the World") condition. Participants will complete assessments of % body fat, mediators (including objectively measured physical activity), moderators, and other outcomes at pre, post, and 6, 12, and 24 month follow-ups.

Detailed Description

Aim 1 will test the hypothesis that Project Health significantly reduces increases in % body fat relative to the Healthy Weight intervention and video control condition during a 2-yr follow-up; secondary outcomes are BMI, depressive symptoms and eating disorder symptoms. The investigators will also compare Healthy Weight to video controls.

Aim 2 will test the hypothesis that Project Health participants will experience increased cognitive dissonance (an uncomfortable psychological state) regarding eating unhealthy foods and engaging in sedentary behaviors, and that changes in dissonance mediate the program's weight gain prevention effects. The investigators will also test whether reduced calorie intake and increased physical activity mediate the effects of Project Health on change in % body fat.

Aim 3 will test the hypothesis that intervention effects are amplified for participants with elevated body dissatisfaction (which should increase motivation change) and preference for consistency (which should maximize dissonance induction) and mitigated for participants who report emotional eating and substance use (because these factors increase risk for overeating).

Conditions

Obesity; Weight Gain; Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Weight

The main goal of the Healthy Weight intervention is to make small, sustainable changes to input and output on a weekly basis to achieve a balance between caloric intake and output. All sessions begin with a brief review of what was covered in the previous session, presentation of educational handouts, careful review of previous behavior change goals, and the development of healthy behavior change plans for the next session. Home exercises for all sessions consist of following individualized diet and exercise goals, and keeping a food and exercise log to determine areas for future healthy changes.

Group Type: ACTIVE_COMPARATOR

Healthy Weight

Intervention Type: BEHAVIORAL

Project Health

Project Health adds dissonance-inducing activities, discussions, and homework activities to the Healthy Weight basic intervention. Each session begins with a verbal commitment to participate (to underscore the voluntary nature of participation), includes discussions of completed home practice assignments and in-session writing/sharing exercises (to create accountability), and concludes with home exercises (to increase level of effort). Completed home assignments are videotaped in subsequent sessions to increase accountability.

Group Type: EXPERIMENTAL

Project Health

Intervention Type: BEHAVIORAL

Control

Some participants will be randomized to control condition whereby they will be given an psychoeducational video ("Weight of the World")to view.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: BEHAVIORAL

Participants will view a video on overweight and obesity

Interventions

Healthy Weight

Intervention Type: BEHAVIORAL

Project Health

Intervention Type: BEHAVIORAL

Placebo Control

Participants will view a video on overweight and obesity

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• University student
• Presents with self-reported "weight concerns"

Exclusion Criteria

• Diagnosis of Eating Disorder
• Obese
• Underweight
• Non-english speaking

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Stice, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Paul Rohde, PhD

Role: STUDY_DIRECTOR

Oregon Research Institute

Heather Shaw, PhD

Role: STUDY_DIRECTOR

Oregon Research Institute

Kyle Burger, PhD

Role: STUDY_DIRECTOR

Oregon Research Institute

Nathan Marti, PhD

Role: STUDY_DIRECTOR

Oregon Research Institute

Locations

Oregon State University

Corvallis, Oregon, United States

University of Oregon

Eugene, Oregon, United States

Oregon Research Institute

Eugene, Oregon, United States

University of Texas, Austin

Austin, Texas, United States

Countries

United States

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Other Identifiers

HD071900

Identifier Type: -

Identifier Source: org_study_id