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Overweight and ObesityPHNCT03710746

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

A study testing Project Health and Response and Attention Training in people with Overweight and Obesity, run by Oregon Research Institute at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 17 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Project Health and Response and Attention Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
2 sitesUnited States
Study dates
8 Oct 2018to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Oregon Research Institute

    Eugene, Oregon, 97403

  • Drexel University

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program

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.

Read the 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.

Being tested
Project Health, Response and Attention Training
Keywords
obesity, overweight, prevention, adolescence, dissonance
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project HealthBehavioural

    A brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions.

  • Response and Attention TrainingBehavioural

    Individualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating.

Study groups in NCT03710746
Study groupRoleWhat they receive
Mixed Group, Food Response TrainingExperimentalParticipants 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.
Receives: Behavioral: Project Health; Behavioral: Response and Attention Training
Mixed Group, Generic Response TrainingExperimentalParticipants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the generic response and attention training intervention.
Receives: Behavioral: Project Health; Behavioral: Response and Attention Training
Female Group, Food Response TrainingExperimentalParticipants 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.
Receives: Behavioral: Project Health; Behavioral: Response and Attention Training
Female Group, Generic Response TrainingExperimentalParticipants in this arm will be assigned to receive Project Health in female-only groups and will complete the generic response and attention training intervention.
Receives: Behavioral: Project Health; Behavioral: Response and Attention Training
Male Group, Food Response TrainingExperimentalParticipants 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.
Receives: Behavioral: Project Health; Behavioral: Response and Attention Training
Male Group, Generic Response TrainingExperimentalParticipants in this arm will be assigned to receive Project Health in male-only groups and will complete the generic response and attention training intervention.
Receives: Behavioral: Project Health; Behavioral: Response and Attention Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Fat

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

    Measured: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

Secondary outcomes (3)
  1. 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.

    Measured: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

  2. Beck Depression Index (BDI)

    Change in depressive symptoms

    Measured: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

  3. Eating Disorder Interview (EDDI)

    Change in eating disorder symptoms

    Measured: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start8 Oct 2018
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03710746
Sponsor's protocol ID
HD093598-01A1
Acronym
PH
Status last verified
Aug 2024
First submitted
8 Oct 2018
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Project Health and Response and Attention Training in people with Overweight and Obesity, run by Oregon Research Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Fat (time frame: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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