NCT01680224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

3.8 years

First QC Date

August 29, 2012

Last Update Submit

September 19, 2018

Conditions

ObesityWeight GainEating Disorders

Keywords

ObesityWeight GainDissonanceCollege,University StudentsEating DisordersObesity PreventionSelective PreventionEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Body Fat Percentage

    We will use air displacement plethysmography (ADP) via the Bod Pod S/T to assess % body fat. Two measures will be averaged. Body density, calculated as body mass divided by estimated body volume, is used to calculate age- and gender-adjusted body fat percentile scores, based on normative reference data (McCarthy et al., 2006). A pilot validity study (N = 30) revealed that direct DEXA measures of % body fat correlates much more strongly with ADP estimates of body fat (r = .88) than with BMI (r = .23). Change in age- and gender-adjusted body fat percentile over the 2-year follow-up will be the primary outcome. This assessment takes 3-5 minutes to complete.

    Changes in body fat from baseline to 2-year follow up

Secondary Outcomes (3)

  • Eating Pathology

    Baseline and post intervention (6 weeks); 6/12/24 month follow-up

  • Negative Affect

    Baseline and post intervention (6 weeks); 6/12/24 month follow-ups

  • Food Craving/Liking

    Baseline, 6 weeks (post intervention), 6/12/24 month follow ups

Other Outcomes (2)

  • Weighing Habits

    Baseline and post intervention (6 weeks); 6/12/24 mo follow-ups

  • Physical Activity

    Baseline and post-intervention (6 weeks); 6/12/24 month follow-ups

Study Arms (3)

Healthy Weight

ACTIVE COMPARATOR

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.

Behavioral: Healthy Weight

Project Health

EXPERIMENTAL

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.

Behavioral: Project Health

Control

PLACEBO COMPARATOR

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

Behavioral: Placebo Control

Interventions

Healthy WeightBEHAVIORAL
Healthy Weight
Project HealthBEHAVIORAL
Project Health
Placebo ControlBEHAVIORAL

Participants will view a video on overweight and obesity

Control

Eligibility Criteria

Age17 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

University of Oregon

Eugene, Oregon, 94703, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

University of Texas, Austin

Austin, Texas, 78713, United States

Location

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  • Call CC, D'Adamo L, Butryn ML, Stice E. Examining weight suppression as a predictor and moderator of intervention outcomes in an eating disorder and obesity prevention trial: A replication and extension study. Behav Res Ther. 2021 Jun;141:103850. doi: 10.1016/j.brat.2021.103850. Epub 2021 Mar 29.

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    PMID: 28290744DERIVED

MeSH Terms

Conditions

ObesityWeight GainFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesSigns and Symptoms, DigestiveMental Disorders

Study Officials

  • Eric Stice, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

  • Paul Rohde, PhD

    Oregon Research Institute

    STUDY DIRECTOR

  • Heather Shaw, PhD

    Oregon Research Institute

    STUDY DIRECTOR

  • Kyle Burger, PhD

    Oregon Research Institute

    STUDY DIRECTOR

  • Nathan Marti, PhD

    Oregon Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

June 30, 2016

Study Completion

May 31, 2018

Last Updated

September 21, 2018

Record last verified: 2018-09

Locations

US(4)