Effectiveness Trial of a Dissonance-Based Obesity Prevention Program (Project Health)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Oregon Research Institute
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01680224
First received: August 29, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Obesity
Weight Gain
Eating Disorders
Behavioral: Healthy Weight
Behavioral: Project Health

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness Trial of a Dissonance-Based Obesity Prevention Program

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Body Fat Percentage [ Time Frame: Changes in body fat from baseline to 2-year follow up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Eating Pathology [ Time Frame: Baseline and post intervention (6 weeks); 6/12/24 month follow-up ] [ Designated as safety issue: No ]
    The Eating Disorder Diagnostic Interview, a brief semi-structured interview, will assess eating disorder symptoms. It provides diagnoses for anorexia nervosa, bulimia nervosa, and binge eating disorder, which will allow us to exclude participants with these disorders. It also provides a continuous measure of overall eating disorder symptoms.

  • Negative Affect [ Time Frame: Baseline and post intervention (6 weeks); 6/12/24 month follow-ups ] [ Designated as safety issue: No ]
    The 20-item Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS: Watson et al., 1988) measures general negative affectivity and depressive symptoms. Using a Likert rating system, participants choose their degree of endorsement of negative affectivity items such as "disgusted with self" and "lonely" (response options: 1 = not at all; 5 = extremely).

  • Food Craving/Liking [ Time Frame: Baseline, 6 weeks (post intervention), 6/12/24 month follow ups ] [ Designated as safety issue: No ]
    The 28-item Food Craving Inventory (FCI; White et al., 2002) assesses subjective cravings for individual foods (pasta, ice cream), asking: "Over the past month, how often have you experienced a craving for the food?"


Other Outcome Measures:
  • Weighing Habits [ Time Frame: Baseline and post intervention (6 weeks); 6/12/24 mo follow-ups ] [ Designated as safety issue: No ]
    Participants will be asked how often they weighed themselves "in the past two weeks" at each assessment.

  • Physical Activity [ Time Frame: Baseline and post-intervention (6 weeks); 6/12/24 month follow-ups ] [ Designated as safety issue: No ]
    Accelerometers will give objective measures of physical activity from each participant at each wave assessment.


Estimated Enrollment: 360
Study Start Date: September 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: Healthy Weight
Experimental: 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.
Behavioral: Project Health
Placebo Comparator: Control
Some participants will be randomized to control condition whereby they will be given an psychoeducational video ("Weight of the World")to view.

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).

  Eligibility

Ages Eligible for Study:   17 Years to 23 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diagnosis of Eating Disorder
  • Obese
  • Underweight
  • Non-english speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680224

Contacts
Contact: Eric Stice, PhD 5414842123 ext 2199 estice@ori.org
Contact: Paul Rhode, PhD 5414842123 ext 2120 paulr@ori.org

Locations
United States, Oregon
Oregon State University Recruiting
Corvallis, Oregon, United States, 97331
Contact: Patricia Ketcham, PhD, CHES       pat.ketcham@oregonstate.edu   
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact: Eric Stice, PhD    541-484-2123 ext 2199    estice@ori.org   
Contact: Paul Rohde, PhD    5414842123 ext 2120    paulr@ori.org   
Principal Investigator: Eric Stice, PhD         
University of Oregon Recruiting
Eugene, Oregon, United States, 94703
United States, Texas
University of Texas, Austin Completed
Austin, Texas, United States, 78713
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Eric Stice, PhD Oregon Research Institute
Study Director: 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
  More Information

Publications:
McMillan, W., Stice, E., & Rohde, P. (2011). High- and low-level dissonance-based eating disorder prevention programs with young women with body image concerns: An experimental trial. J Consult Clin Psychol, 79(1), 129-134.
Stice, E., Rohde, P., Shaw, H., & Gau, J. (2011). An effectiveness trial of a selected dissonance-based eating disorder prevention program for female high school students: Long-term effects. Journal of Consulting and Clinical Psychology, 79, 500-508.
Stice, E., Rohde, P., Shaw, H., & Marti, N. (in press). Efficacy trial of a selected prevention program targeting both eating disorder symptoms and unhealthy weight gain among female college students. Journal of Consulting and Clinical Psychology.
van Strien, T., Frijters, J. E., Van Staveren, W. A., Defares, P. B., & Deurenberg, P. (1986). The predictive validity of the Dutch Restrained Eating Scale. Int J Eat Disord, 5, 747-755

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01680224     History of Changes
Other Study ID Numbers: HD071900
Study First Received: August 29, 2012
Last Updated: March 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Oregon Research Institute:
Obesity
Weight Gain
Dissonance
College,University Students
Eating Disorders
Obesity Prevention
Selective Prevention
Effectiveness

Additional relevant MeSH terms:
Eating Disorders
Obesity
Weight Gain
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 24, 2014