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Effectiveness Trial of a Dissonance-Based Obesity Prevention Program

Effectiveness Trial of a Dissonance-Based Obesity Prevention Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01680224
Acronym
Project Health
Enrollment
364
Registered
2012-09-07
Start date
2012-09-01
Completion date
2018-05-31
Last updated
2018-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders, Obesity, Weight Gain

Keywords

Obesity, Weight Gain, Dissonance, College,University Students, Eating Disorders, Obesity Prevention, Selective Prevention, Effectiveness

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).

Interventions

BEHAVIORALHealthy Weight
BEHAVIORALProject Health
BEHAVIORALPlacebo Control

Participants will view a video on overweight and obesity

Sponsors

Oregon Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to 23 Years
Healthy volunteers
Yes

Inclusion criteria

* University student * Presents with self-reported weight concerns

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Body Fat PercentageChanges in body fat from baseline to 2-year follow upWe 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

MeasureTime frameDescription
Eating PathologyBaseline and post intervention (6 weeks); 6/12/24 month follow-upThe 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 AffectBaseline and post intervention (6 weeks); 6/12/24 month follow-upsThe 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/LikingBaseline, 6 weeks (post intervention), 6/12/24 month follow upsThe 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

MeasureTime frameDescription
Weighing HabitsBaseline and post intervention (6 weeks); 6/12/24 mo follow-upsParticipants will be asked how often they weighed themselves in the past two weeks at each assessment.
Physical ActivityBaseline and post-intervention (6 weeks); 6/12/24 month follow-upsAccelerometers will give objective measures of physical activity from each participant at each wave assessment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026