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Inhibitory Control TrainingNCT04659837

Training Response Inhibition to Obesogenic Foods

A study testing No-Added-Sugar Diet in people with Inhibitory Control Training and Gameifaction, run by Drexel University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dietary choices, and in particular, excess calorie intake leading to obesity, are strong, but reversible risk factors for cancer. For example, foods high in added sugars are low-nutrient, high calorie foods that increase the risk of cancer by promoting weight gain. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Inhibitory Control Training, Gameifaction
What is being tested?
No-Added-Sugar Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteUnited States
Study dates
1 Jun 2016to 1 Dec 2019
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI 25-50
  • Baseline consumption of ≥ 3 servings/day of high-sugar foods

Who cannot join

  • Medical or psychiatric conditions that could interfere with the ability to comply with diet recommendations,
  • pregnancy (or planning to become pregnant in the next 12 months) or current breastfeeding,
  • a history of bariatric surgery,
  • weight loss of five percent or more within the last six months
  • beginning or changing a dosage of a weight-affecting medication within the last three months

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Drexel University

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Reducing Cancer Risk by Training Response Inhibition to Obesogenic Foods

Dietary choices, and in particular, excess calorie intake leading to obesity, are strong, but reversible risk factors for cancer. For example, foods high in added sugars are low-nutrient, high calorie foods that increase the risk of cancer by promoting weight gain. As such, the reduction of sweets is consistent with American Institute for Cancer Research and the American Cancer Society dietary recommendations. Behavioral interventions to alter diet have limited long-term efficacy, most likely because eating decisions are governed by automatic neurocognitive processes that are not addressed in conventional interventions. In particular, the ability to refrain from consuming unhealthy, but widely available, palatable foods, is increasingly understood to depend on inhibitory control, i.e., the ability to cut off action tendencies that are put in motion by innate drives towards rewarding behaviors. Recent work by our team and others have demonstrated that computer-based inhibitory control trainings result in short-term, specific changes in behavior, such as reducing intake of salty snack food, chocolate, and alcoholic beverages. An automatized, home computer-based inhibitory control training offers the potential of an inexpensive and highly disseminable method of lowering cancer risk across wide swaths of the population. As such, we aim to evaluate the feasibility, acceptability, mechanism of action, effectiveness and persistence of a home computer-based inhibitory control training. In particular, we hypothesize that a high-repetition training in inhibitory control will result in increased adherence to a low-sugar diet, and that effects will be mediated through improved inhibitory control. We further hypothesize that gamefying the training will improve efficacy because it will boost compliance with the daily trainings. We also hypothesize that the training will be most effective for those starting of with impaired inhibitory control, as well as those with strongest desire for palatable foods and those with strongest explicit health goals. Lastly, we aim to examine the impact of inhibitory control training on secondary outcomes, including on overall caloric intake, and on short-term weight loss. To achieve these aims, the proposed study will recruit 100 overweight and obese individuals who currently eat high-sugar diets, and who wish to improve their diets. Participants will be assigned a reduced-sugar diet for 8 weeks. After a baseline period, participants will be randomized, via a 2 x 2 factorial design, to receive 6 weeks of either inhibitory control training or a sham training, and either a gamified or non-gameified training. The 6-week intervention will consist of 15 minutes per day of home computer- based inhibitory control training, and will be followed by a 1-week booster and then 1-week follow-up period. Dietary adherence will be measured via a food frequency questionnaire and via automated 24-hour food recall. Neurocognitive variables will be assessed pre and post-training in order to test trainings' mechanism of action, and moderation will be assessed through baseline trait measures of explicit health goals, implicit attitudes towards appetitive stimuli, body mass index, and responsivity to food cues.

Being tested
No-Added-Sugar Diet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No-Added-Sugar DietBehavioural

    All participants received a no-added-sugar dietary intervention and followed the diet during the course of the study.

Study groups in NCT04659837
Study groupRoleWhat they receive
Inhibitory Control TrainingActive comparatorActive Inhibitory Control Training vs. Sham Inhibitory Control Training
Receives: Behavioral: No-Added-Sugar Diet
GameificationOtherGameified elements added vs. No gameified elements added
Receives: Behavioral: No-Added-Sugar Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Measured: 8 weeks

  2. Sweets consumption

    Measured: 8 weeks

  3. Inhibitory control in response to high-sugar foods

    Inhibitory control in response to high-sugar foods is measured via performance (i.e., speed of inhibiting prepotent responses to high-sugar food stimuli) on the daily inhibitory control training (i.e., Go/No-Go) task.

    Measured: 8 weeks

Secondary outcomes (2)
  1. Compliance with daily inhibitory control training prescription

    Compliance with completing the daily inhibitory control training prescription will be measured as the number of days the task was completed out of the total number of days it was prescribed.

    Measured: 8 weeks

  2. Enjoyment of the daily training task

    Enjoyment and acceptability of the inhibitory control training will be assessed using self-report. Participants will be asked to rate how 'fun' and 'boring' the training was on a Likert scale.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start1 Jun 2016
  3. Primary completion7 Aug 2019
  4. Study completion1 Dec 2019

Resources

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
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659837
Sponsor's protocol ID
R21CA191859
Status last verified
Dec 2019
First submitted
21 Jul 2020
Last updated
9 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Forman EM, Manasse SM, Dallal DH, Crochiere RJ, Loyka CM, Butryn ML, Juarascio AS, Houben K. Computerized neurocognitive training for improving dietary health and facilitating weight loss. J Behav Med. 2019 Dec;42(6):1029-1040. doi: 10.1007/s10865-019-00024-5. Epub 2019 Mar 19.

    PubMed 30891657

Questions about this trial

What is this clinical trial studying?

A study testing No-Added-Sugar Diet in people with Inhibitory Control Training and Gameifaction, run by Drexel University 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 2 inclusion and 5 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 9 Dec 2020. 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?

Weight (time frame: 8 weeks). 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?

On the ClinicalTrials.gov record for NCT04659837, which also lists 1 linked publication.

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 9 Dec 2020.

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