Training Response Inhibition to Obesogenic Foods

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.

Study Overview

• Status: Completed
• Conditions: Inhibitory Control Training; Gameifaction
• Intervention / Treatment: Behavioral: No-Added-Sugar Diet

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Inhibitory Control Training; Active Inhibitory Control Training vs. Sham Inhibitory Control Training	Behavioral: No-Added-Sugar Diet; All participants received a no-added-sugar dietary intervention and followed the diet during the course of the study.
OTHER: Gameification; Gameified elements added vs. No gameified elements added	Behavioral: No-Added-Sugar Diet; All participants received a no-added-sugar dietary intervention and followed the diet during the course of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight		8 weeks
Sweets consumption		8 weeks
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
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.	8 weeks

Collaborators and Investigators

• Sponsor: Drexel University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): August 7, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (ACTUAL): December 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: R21CA191859 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No