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Project Health: Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program (PH)

Primary Purpose

Overweight and Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Health
Response and Attention Training
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring obesity, overweight, prevention, adolescence, dissonance

Eligibility Criteria

17 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Current at least moderate weight concerns (response of moderate, severe or extreme to the presence of weight concerns question)
  • BMI between 20 and 30

Exclusion Criteria:

  • Current diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder

Sites / Locations

  • Oregon Research Institute
  • Drexel University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Mixed Group, Food Response Training

Mixed Group, Generic Response Training

Female Group, Food Response Training

Female Group, Generic Response Training

Male Group, Food Response Training

Male Group, Generic Response Training

Arm Description

Participants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the food-focused response and attention training intervention.

Participants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the generic response and attention training intervention.

Participants in this arm will be assigned to receive Project Health in female-only groups and will complete the food-focused response and attention training intervention.

Participants in this arm will be assigned to receive Project Health in female-only groups and will complete the generic response and attention training intervention.

Participants in this arm will be assigned to receive Project Health in male-only groups and will complete the food-focused response and attention training intervention.

Participants in this arm will be assigned to receive Project Health in male-only groups and will complete the generic response and attention training intervention.

Outcomes

Primary Outcome Measures

Body Fat
Change in percentage of body fat (Not collected during COVID-19 shelter-at-home order)

Secondary Outcome Measures

Weight Concerns Scale from the Eating Disorder Examination Questionnaire (EDE-Q)
Change in weight concerns. Scale scores range from 0 to 42 with higher scores being indicative of higher weight concerns.
Beck Depression Index (BDI)
Change in depressive symptoms
Eating Disorder Interview (EDDI)
Change in eating disorder symptoms

Full Information

First Posted
October 8, 2018
Last Updated
August 14, 2023
Sponsor
Oregon Research Institute
Collaborators
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT03710746
Brief Title
Project Health: Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program
Acronym
PH
Official Title
Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
June 3, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality.
Detailed Description
Prevention is key for combating obesity, but few programs have prevented future increases in BMI and onset of overweight/obesity, particularly during late adolescence when youth often assume responsibility for dietary intake and exercise choices. One exception is a brief 6-hr dissonance-based program (Project Health) wherein participants make small lasting incremental lifestyle changes to dietary intake and exercise to reach energy balance, and discuss costs of obesity, an unhealthy diet, and sedentary behavior, and benefits of leanness, a healthy diet, and exercise, which prompts them to align their attitudes with their publicly displayed behavior. These activities promote the internalization of health goals and executive control over lifestyle behaviors. Late adolescents randomized to Project Health showed fewer increases in BMI and a 41% and 43% reduction in overweight/obesity onset over 2-yr follow-up compared to a version of the program lacking dissonance induction activities and an obesity education condition. Project Health appears to be the first program to produce these key obesity prevention effects relative to an alternative intervention, but it is critical to increase effects. A dissonance-based prevention program was more effective when implemented in single- versus mixed-sex groups, theoretically, because it promoted greater participation in dissonance-inducing discussions. Aim 1a is to test whether the weight gain prevention effects will be larger when Project Health is implemented in single-sex groups; the investigators will randomize 450 17-20-year-olds to complete Project Health in female, male, or mixed-sex groups, assessing outcomes at pretest, post-test, and 6, 12, 24, and 36-month follow-ups. Aim 1b is to test whether greater participation in dissonance-inducing discussions and group cohesion mediate the effect of condition on any superior weight gain prevention effects. Adolescents who show greater functional Magnetic Resonance Imaging( fMRI)-assessed reward and attention region responsivity to food images exhibit elevated future weight gain, implying that reducing this responsivity may reduce future weight gain. In a pilot trial, late adolescents who completed go/no-go, stop-signal, and respond-signal computer training in which they repeatedly inhibit responses to high-calorie foods and respond to low-calorie foods, and dot-probe and visual-search computer tasks that train attention away from high-calorie foods and to low-calorie foods, showed a greater reduction in reward and attention region responsivity to, palatability rating of, and willingness to pay for, high-calorie foods, suggesting reduced valuation and attentional bias, as well as greater fat loss over 1-yr follow-up versus controls who completed the training with non-food images. Aim 2a is to test whether adding food response and attention training to Project Health will produce larger weight gain prevention effects. Participants in the 3 conditions will be randomized to complete response and attention training for 25-mins after each of the 6-sessions with either food or non-food images. Aim 2b is to test whether reduced palatability ratings of, willingness to pay, and attentional bias for high-calorie foods mediate the effect of training condition on any superior weight gain prevention effects. During the Coronavirus Disease 2019 (COVID-19) shelter-at-home order, the investigators will not measure in-person only outcomes including assessments using the BodPod (a body composition tracking system using air displacement plethysmography), and height and weight measurement for BMI calculation for all participants that have assessments due during this order. The investigators will continue to conduct intervention groups that will be administered on a virtual platform.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
obesity, overweight, prevention, adolescence, dissonance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be masked to their response training condition. Outcomes assessors will be masked to both participant conditions.
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mixed Group, Food Response Training
Arm Type
Experimental
Arm Description
Participants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the food-focused response and attention training intervention.
Arm Title
Mixed Group, Generic Response Training
Arm Type
Experimental
Arm Description
Participants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the generic response and attention training intervention.
Arm Title
Female Group, Food Response Training
Arm Type
Experimental
Arm Description
Participants in this arm will be assigned to receive Project Health in female-only groups and will complete the food-focused response and attention training intervention.
Arm Title
Female Group, Generic Response Training
Arm Type
Experimental
Arm Description
Participants in this arm will be assigned to receive Project Health in female-only groups and will complete the generic response and attention training intervention.
Arm Title
Male Group, Food Response Training
Arm Type
Experimental
Arm Description
Participants in this arm will be assigned to receive Project Health in male-only groups and will complete the food-focused response and attention training intervention.
Arm Title
Male Group, Generic Response Training
Arm Type
Experimental
Arm Description
Participants in this arm will be assigned to receive Project Health in male-only groups and will complete the generic response and attention training intervention.
Intervention Type
Behavioral
Intervention Name(s)
Project Health
Intervention Description
A brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions.
Intervention Type
Behavioral
Intervention Name(s)
Response and Attention Training
Intervention Description
Individualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating.
Primary Outcome Measure Information:
Title
Body Fat
Description
Change in percentage of body fat (Not collected during COVID-19 shelter-at-home order)
Time Frame
Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Secondary Outcome Measure Information:
Title
Weight Concerns Scale from the Eating Disorder Examination Questionnaire (EDE-Q)
Description
Change in weight concerns. Scale scores range from 0 to 42 with higher scores being indicative of higher weight concerns.
Time Frame
Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Title
Beck Depression Index (BDI)
Description
Change in depressive symptoms
Time Frame
Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Title
Eating Disorder Interview (EDDI)
Description
Change in eating disorder symptoms
Time Frame
Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Current at least moderate weight concerns (response of moderate, severe or extreme to the presence of weight concerns question) BMI between 20 and 30 Exclusion Criteria: Current diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric M Stice, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will share all study data via the NICHD Data and Specimen Hub (DASH), which is the centralized resource for researchers to store and access data from NICHD-funded research studies to use for secondary research. All data, with the exception of video recordings of the participants in treatment (which cannot be effectively de-identified), will be provided.
IPD Sharing Time Frame
After all follow-up assessments are completed and the main project papers are published, a dataset stripped of identifiers prior to release will be made available without cost to researchers and analysts.
IPD Sharing Access Criteria
Individuals wishing to view Individual Participant Data (IPD) can create a free user account at DASH and submit a request which will be reviewed and approved through the NICHD Dash administrator.
Links:
URL
http://www.projecthealthori.weebly.com
Description
Project Health Website
URL
http://www.ori.org
Description
Oregon Research Institute Website
URL
http://drexel.edu/coas/academics/departments-centers/well-center/
Description
Drexel University: WELL Center Website

Learn more about this trial

Project Health: Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program

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