Go/No-Go Intervention for Weight Loss

NCT ID: NCT04624087

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2021-11-01

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High Dose

Participants will perform the food-specific computerized go/no-go training four times per week for 4 weeks.

Group Type: EXPERIMENTAL

food-specific go/no-go computerized training

Intervention Type: BEHAVIORAL

Participants will perform the computerized food specific go/no-go training a designated number of times over a four week duration (frequency varies by group). Each training session will last approximately 10 minutes and occur on different days of the week.

Low Dose

Participants will perform the food-specific computerized go/no-go training one time per week for 4 weeks.

Group Type: EXPERIMENTAL

food-specific go/no-go computerized training

Intervention Type: BEHAVIORAL

Participants will perform the computerized food specific go/no-go training a designated number of times over a four week duration (frequency varies by group). Each training session will last approximately 10 minutes and occur on different days of the week.

Active Control

Participants will perform the generalized, nonfood-specific computerized go/no-go training one time per week for 4 weeks.

Group Type: ACTIVE_COMPARATOR

nonfood-specific go/no-go computerized training

Intervention Type: BEHAVIORAL

Participants will perform the computerized general go/no-go training 1 time per week over a four week duration. Each training session will last approximately 10 minutes and occur on different days of the week.

Interventions

food-specific go/no-go computerized training

Participants will perform the computerized food specific go/no-go training a designated number of times over a four week duration (frequency varies by group). Each training session will last approximately 10 minutes and occur on different days of the week.

Intervention Type: BEHAVIORAL

nonfood-specific go/no-go computerized training

Participants will perform the computerized general go/no-go training 1 time per week over a four week duration. Each training session will last approximately 10 minutes and occur on different days of the week.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lara LaCaille, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Duluth

Duluth, Minnesota, United States

Countries

United States

Other Identifiers

00010522

Identifier Type: -

Identifier Source: org_study_id