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Go/No-Go Intervention for Weight Loss

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
food-specific go/no-go computerized training
nonfood-specific go/no-go computerized training
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Duluth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

High Dose

Low Dose

Active Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).
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
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.

Secondary Outcome Measures

Change in binge eating behaviors from baseline to post 4-week intervention, to 6-month follow-up.
This will be measured using the binge eating questions of the Eating Disorder Examination Questionnaire; minimum value = 0; maximum value = unlimited; higher scores for this measure means worse outcomes
Change in liking of foods from baseline to post 4-week intervention, to 6-month
This will be measured using a visual analog scale; minimum value = -100; maximum value = 100; higher scores for this measure on healthy foods means better outcomes, higher scores on this measure for unhealthy foods means worse outcomes
Change in automatic responses to healthy and unhealthy foods from baseline to post 4-week intervention, to 6-month
This will be measured using an impulsive food choice test.

Full Information

First Posted
October 13, 2020
Last Updated
March 17, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04624087
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose
Arm Type
Experimental
Arm Description
Participants will perform the food-specific computerized go/no-go training four times per week for 4 weeks.
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Participants will perform the food-specific computerized go/no-go training one time per week for 4 weeks.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Participants will perform the generalized, nonfood-specific computerized go/no-go training one time per week for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
food-specific go/no-go computerized training
Intervention Description
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
Intervention Name(s)
nonfood-specific go/no-go computerized training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight from baseline to post 4-week intervention, to 6-month follow-up
Description
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).
Time Frame
baseline, post 4-week intervention, 6-month follow-up
Title
Change in disinhibition scores from baseline to post 4-week intervention, to 6-month follow-up.
Description
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
Time Frame
baseline, post 4-week intervention, 6-month follow-up
Title
Change in frequency of food consumption from baseline to post 4-week intervention, to 6-month follow-up.
Description
This will be measured using a food frequency questionnaire assessing food intake over the previous month.
Time Frame
baseline, post 4-week intervention, 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in binge eating behaviors from baseline to post 4-week intervention, to 6-month follow-up.
Description
This will be measured using the binge eating questions of the Eating Disorder Examination Questionnaire; minimum value = 0; maximum value = unlimited; higher scores for this measure means worse outcomes
Time Frame
baseline, post 4-week intervention, 6-month follow-up
Title
Change in liking of foods from baseline to post 4-week intervention, to 6-month
Description
This will be measured using a visual analog scale; minimum value = -100; maximum value = 100; higher scores for this measure on healthy foods means better outcomes, higher scores on this measure for unhealthy foods means worse outcomes
Time Frame
baseline, post 4-week intervention, 6-month follow-up
Title
Change in automatic responses to healthy and unhealthy foods from baseline to post 4-week intervention, to 6-month
Description
This will be measured using an impulsive food choice test.
Time Frame
baseline, post 4-week intervention, 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara LaCaille, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55812
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Go/No-Go Intervention for Weight Loss

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