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

Primary Purpose

Obesity, Weight Gain, Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Weight
Project Health
Placebo Control
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Weight Gain, Dissonance, College,University Students, Eating Disorders, Obesity Prevention, Selective Prevention, Effectiveness

Eligibility Criteria

17 Years - 23 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Oregon State University
  • University of Oregon
  • Oregon Research Institute
  • University of Texas, Austin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Healthy Weight

Project Health

Control

Arm Description

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.

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.

Some participants will be randomized to control condition whereby they will be given an psychoeducational video ("Weight of the World")to view.

Outcomes

Primary Outcome Measures

Body Fat Percentage
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
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
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
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?"

Full Information

First Posted
August 29, 2012
Last Updated
September 19, 2018
Sponsor
Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01680224
Brief Title
Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
Acronym
Project Health
Official Title
Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2012 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Gain, Eating Disorders
Keywords
Obesity, Weight Gain, Dissonance, College,University Students, Eating Disorders, Obesity Prevention, Selective Prevention, Effectiveness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Weight
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Project Health
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Some participants will be randomized to control condition whereby they will be given an psychoeducational video ("Weight of the World")to view.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Weight
Intervention Type
Behavioral
Intervention Name(s)
Project Health
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control
Intervention Description
Participants will view a video on overweight and obesity
Primary Outcome Measure Information:
Title
Body Fat Percentage
Description
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.
Time Frame
Changes in body fat from baseline to 2-year follow up
Secondary Outcome Measure Information:
Title
Eating Pathology
Description
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.
Time Frame
Baseline and post intervention (6 weeks); 6/12/24 month follow-up
Title
Negative Affect
Description
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).
Time Frame
Baseline and post intervention (6 weeks); 6/12/24 month follow-ups
Title
Food Craving/Liking
Description
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?"
Time Frame
Baseline, 6 weeks (post intervention), 6/12/24 month follow ups
Other Pre-specified Outcome Measures:
Title
Weighing Habits
Description
Participants will be asked how often they weighed themselves "in the past two weeks" at each assessment.
Time Frame
Baseline and post intervention (6 weeks); 6/12/24 mo follow-ups
Title
Physical Activity
Description
Accelerometers will give objective measures of physical activity from each participant at each wave assessment.
Time Frame
Baseline and post-intervention (6 weeks); 6/12/24 month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: University student Presents with self-reported "weight concerns" Exclusion Criteria: Diagnosis of Eating Disorder Obese Underweight Non-english speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Rohde, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heather Shaw, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kyle Burger, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nathan Marti, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Oregon State University
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
94703
Country
United States
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
University of Texas, Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78713
Country
United States

12. IPD Sharing Statement

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Effectiveness Trial of a Dissonance-Based Obesity Prevention Program

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