Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03710746 |
| Other study ID # |
HD093598-01A1 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 8, 2018 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Oregon Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
