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

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ClinicalTrials.gov Identifier: NCT01680224
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

Tracking Information
First Submitted Date  ICMJE August 29, 2012
First Posted Date  ICMJE September 7, 2012
Last Update Posted Date September 21, 2018
Actual Study Start Date  ICMJE September 1, 2012
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
Body Fat Percentage [ Time Frame: Changes in body fat from baseline to 2-year follow up ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
  • Eating Pathology [ Time Frame: Baseline and post intervention (6 weeks); 6/12/24 month follow-up ]
    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 ]
    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 ]
    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?"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 3, 2012)
  • Weighing Habits [ Time Frame: Baseline and post intervention (6 weeks); 6/12/24 mo follow-ups ]
    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 ]
    Accelerometers will give objective measures of physical activity from each participant at each wave assessment.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
Official Title  ICMJE Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Weight Gain
  • Eating Disorders
Intervention  ICMJE
  • Behavioral: Healthy Weight
  • Behavioral: Project Health
  • Behavioral: Placebo Control
    Participants will view a video on overweight and obesity
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Behavioral: Placebo Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2018)
364
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2012)
360
Actual Study Completion Date  ICMJE May 31, 2018
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Diagnosis of Eating Disorder
  • Obese
  • Underweight
  • Non-english speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 23 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680224
Other Study ID Numbers  ICMJE HD071900
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oregon Research Institute
Study Sponsor  ICMJE Oregon Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Oregon Research Institute
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP