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Completed

NCT Number: NCT01680224

Effectiveness Trial of a Dissonance-Based Obesity Prevention Program

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Eating Disorders Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Weight Gain

Age range

17 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon State University, Corvallis, Oregon, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Healthy Weight

Behavioral

Project Health

Behavioral

Placebo control

Behavioral

Participants will view a video on overweight and obesity

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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?"

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Registry information

Acronym: Project Health

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Sep 7, 2012
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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