Overweight and ObesityNCT04624087
Go/No-Go Intervention for Weight Loss
A study testing food-specific go/no-go computerized training and nonfood-specific go/no-go computerized training in people with Overweight and Obesity, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- food-specific go/no-go computerized training and nonfood-specific go/no-go computerized training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Duluth
Duluth, Minnesota, 55812
About this study
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
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.
Read the 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
- Being tested
- food-specific go/no-go computerized training, nonfood-specific go/no-go computerized training
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food-specific go/no-go computerized trainingBehavioural
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.
nonfood-specific go/no-go computerized trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High Dose | Experimental | Participants will perform the food-specific computerized go/no-go training four times per week for 4 weeks. Receives: 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. Receives: 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. Receives: Behavioral: nonfood-specific go/no-go computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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.
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
Measured: baseline, post 4-week intervention, 6-month follow-up
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
Measured: 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
This will be measured using an impulsive food choice test.
Measured: baseline, post 4-week intervention, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start19 Oct 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lara LaCaille, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624087
- Sponsor's protocol ID
- 00010522
- Status last verified
- Mar 2022
- First submitted
- 13 Oct 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04624087
- Acronym / sponsor ID
- 00010522
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose | Experimental | Behavioral: food-specific go/no-go computerized trainingParticipants will perform the food-specific computerized go/no-go training four times per week for 4 weeks. |
| Low Dose | Experimental | Behavioral: food-specific go/no-go computerized trainingParticipants will perform the food-specific computerized go/no-go training one time per week for 4 weeks. |
| Active Control | Active comparator | Behavioral: nonfood-specific go/no-go computerized trainingParticipants will perform the generalized, nonfood-specific computerized go/no-go training one time per week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food-specific go/no-go computerized trainingParticipants 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. | Behavioural | High Dose, Low Dose |
| nonfood-specific go/no-go computerized trainingParticipants 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. | Behavioural | Active Control |
Primary outcome
Change in body weight from baseline to post 4-week intervention, to 6-month follow-up
Time frame: baseline, post 4-week intervention, 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.
Time frame: baseline, post 4-week intervention, 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.
Time frame: baseline, post 4-week intervention, 6-month follow-up
This will be measured using a food frequency questionnaire assessing food intake over the previous month.
3 secondary outcomes
Change in binge eating behaviors from baseline to post 4-week intervention, to 6-month follow-up.
Time frame: baseline, post 4-week intervention, 6-month follow-up
Change in liking of foods from baseline to post 4-week intervention, to 6-month
Time frame: 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
Time frame: baseline, post 4-week intervention, 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Overweight and Obesity
Recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara LaCaille, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food-specific go/no-go computerized training and nonfood-specific go/no-go computerized training in people with Overweight and Obesity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from baseline to post 4-week intervention, to 6-month follow-up (time frame: baseline, post 4-week intervention, 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.