Clinical trial NCT04624087: Go/No-Go Intervention for Weight Loss
Official title: The Effect of Go/No-Go Training Dosage on Weight Loss, Food Evaluation, and Disinhibition in Overweight and Obese Individuals: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of a food-specific Go/No-Go (GNG) computerized training task on weight loss, food evaluation, and disinhibition in a population of overweight and obese individuals.

Detailed description: Within the current obesogenic environment, the prevalence of overweight and obesity has dramatically increased over the past 40 years. As a result, approximately 40% of Americans attest to being on a diet, with most of these efforts being unsuccessful. Most weight loss diets rely on self-control and reflective thinking (e.g., making conscious food choices multiple times per day), despite the fact that responses to appetitive foods often occur through implicit (unconscious) processes. The proposed study is a randomized clinical trial for weight loss that targets these implicit processes through the use of a computerized, food-specific, go/no-go task. This task has previously resulted in reduced food consumption in laboratory settings, and small but significant weight loss in two brief intervention studies. The purpose of this study is to replicate one prior study and to compare different doses of the intervention. Participants will be assigned to one of three groups: high intensity, low intensity, or active control, and will be assessed on a number of variables pre- and post-intervention. Changes in body weight, food evaluation, frequency of self-reported food consumption, and eating disinhibition scores will be evaluated. It is hypothesized that individuals receiving the food-specific go/no-go training (high intensity and low intensity groups) will experience greater weight loss, decreased disinhibition with food, and reduced snacking of the targeted foods than those in the active control group. It is also hypothesized that the high intensity intervention will be more effective than the low intensity intervention across these variables. Moderators (e.g., dietary restraint, disinhibition) will also be explored throughout this study, along with the mechanism of devaluation of specific foods.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 25
* Age ≥ 18
* Consume some of the determined "no-go" snack foods at least three times per week (assessed using a food frequency questionnaire)
* A desire to lose weight

Exclusion Criteria:

* Medical condition limiting dietary intake
* Medical condition directly affecting weight
* Current use of weight loss medication
* Actively enrolled in a formal weight loss program currently or within the past 6 months (e.g., Weight Watchers)
* History of bariatric surgery
* Currently pregnant
* Current smoker
* Smoking cessation within the past year

Primary outcomes:
measure: Change in body weight from baseline to post 4-week intervention, to 6-month follow-up
timeFrame: baseline, post 4-week intervention, 6-month follow-up
measure: Change in disinhibition scores from baseline to post 4-week intervention, to 6-month follow-up.
timeFrame: baseline, post 4-week intervention, 6-month follow-up
measure: Change in frequency of food consumption from baseline to post 4-week intervention, to 6-month follow-up.
timeFrame: baseline, post 4-week intervention, 6-month follow-up
Secondary outcomes:
measure: Change in binge eating behaviors from baseline to post 4-week intervention, to 6-month follow-up.
timeFrame: baseline, post 4-week intervention, 6-month follow-up
measure: Change in liking of foods from baseline to post 4-week intervention, to 6-month
timeFrame: baseline, post 4-week intervention, 6-month follow-up
measure: Change in automatic responses to healthy and unhealthy foods from baseline to post 4-week intervention, to 6-month
timeFrame: baseline, post 4-week intervention, 6-month follow-up
Other outcomes:
Locations:
city: Duluth
country: United States
facility: University of Minnesota Duluth
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Lara LaCaille, PhD
role: PRINCIPAL_INVESTIGATOR
References: