Go/No-Go Intervention for Weight Loss

NCT04624087 | Completed

• 1 other identifier: 00010522
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (3)

• Change in body weight from baseline to post 4-week intervention, to 6-month follow-up

  Body weight will be measured by participant using personal or university scale. Participants will take a picture of their weight send it to the research team (Due to COVID-19 precautions, in person weighing is not possible).

  baseline, post 4-week intervention, 6-month follow-up

• Change in disinhibition scores from baseline to post 4-week intervention, to 6-month follow-up.

  This will be measured using the Disinhibition subscale of the Three Factor Eating Questionnaire; minimum value = 0; maximum value = 16; higher scores for this measure means worse outcomes

  baseline, post 4-week intervention, 6-month follow-up

• Change in frequency of food consumption from baseline to post 4-week intervention, to 6-month follow-up.

  This will be measured using a food frequency questionnaire assessing food intake over the previous month.

  baseline, post 4-week intervention, 6-month follow-up

Secondary Outcomes (3)

• Change in binge eating behaviors from baseline to post 4-week intervention, to 6-month follow-up.

  baseline, post 4-week intervention, 6-month follow-up

• Change in liking of foods from baseline to post 4-week intervention, to 6-month

  baseline, post 4-week intervention, 6-month follow-up

• Change in automatic responses to healthy and unhealthy foods from baseline to post 4-week intervention, to 6-month

  baseline, post 4-week intervention, 6-month follow-up

Study Arms (3)

High Dose

EXPERIMENTAL

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

Behavioral: food-specific go/no-go computerized training

Low Dose

EXPERIMENTAL

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

Behavioral: food-specific go/no-go computerized training

Active Control

ACTIVE COMPARATOR

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

Behavioral: nonfood-specific go/no-go computerized training

Interventions

food-specific go/no-go computerized training 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.

High Dose; Low Dose

nonfood-specific go/no-go computerized training 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.

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Duluth

Duluth, Minnesota, 55812, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lara LaCaille, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: November 10, 2020
• Study Start: October 19, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)