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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Weight Gain Eating Disorders Behavioral: Healthy Weight Behavioral: Project Health Behavioral: Placebo Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: Placebo Control
Participants will view a video on overweight and obesity


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680224


Locations
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United States, Oregon
Oregon State University
Corvallis, Oregon, United States, 97331
University of Oregon
Eugene, Oregon, United States, 94703
Oregon Research Institute
Eugene, Oregon, United States, 97403
United States, Texas
University of Texas, Austin
Austin, Texas, United States, 78713
Sponsors and Collaborators
Oregon Research Institute
Investigators
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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
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Publications:
Boomsma. (2000). Reporting analyses of covariance structures. Structural Equation Modeling, 7, 461-483.
Cialdini, R. B., Trost, M. R., & Newsom, J. T. (1995). Preference for consistency: The development of a valid measure and the discovery of surprising behavioral implications. J Pers Soc Psychol, 69, 318-328.
Eisenberg, N., Cialdini, R. B., McCreath, H., Shell, R. (1989). Consistency-based compliance in children: when and why do consistency procedures have immediate effects? International Journal of Behavioral Development, 12, 351-367.
Ello-Martin, J. A., Roe, L., & Rolls, B. (2004). A diet reduced in energy density results in greater weight loss than a diet reduced in fat. Obes Res, 12, A23-A23.
Everitt, B., & Pickles, A. (2004). Statistical aspects of the design and analysis of clinical trials. London: Imperial College Press.
Festinger, L. (1957). A theory of cognitive dissonance. Stanford University Press.
Green, H. J., Frank, R. M., Butwell, A., & Beck, O. J. (2007). Implementation and evaluation of brief cognitivebehavioural therapy in a mental health acute assessment and treatment service. Behaviour Change, 24(2), 87-98.
Lipsey, M. W., & Wilson, D. B. (2001). Practical meta-analysis. Thousand Oaks, CA: Sage
MacKinnon, D. P. (2008). Multivariate Applications: Introduction to Statistical Mediation Analysis. New York: Lawrence Erlbaum Associates.
Muthén, L. K., & Muthén, B. O. (1998-2010). Mplus User's Guide (6th ed.). Los Angeles: Muthén & Muthén.
Muthén, L. K., & Muthén, B. O. (2002). How to use a Monte Carlo study to decide on sample size and determine power. Structural Equation Modeling, 9, 599-620.
Rolls, B., & Barnett, R. (2000). Volumetrics: Feel full on fewer calories. New York, NY: Harper Collins
Rolls, B., & Barnett, R. (2000). Volumetrics: Feel full on fewer calories. New York, NY: Harper Collins.
Schwitzer, A., & Choate, L., (2007). College student needs and counseling responses. Journal of College Counseling, 10, 3-5.
Singer, J. D., & Willett, J. B. (2003). Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York: Oxford University Press.
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01680224    
Other Study ID Numbers: HD071900
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Keywords provided by Oregon Research Institute:
Obesity
Weight Gain
Dissonance
College,University Students
 Eating Disorders
Obesity Prevention
Selective Prevention
Effectiveness
Additional relevant MeSH terms:
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Obesity
Weight Gain
Feeding and Eating Disorders
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Mental Disorders
Body Weight Changes