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Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program

Primary Purpose

Obesity, Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gamified behavioral weight loss treatment
mHealth behavioral weight loss treatment
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Individuals must be of overweight or obese BMI (25-50 kg/m)
  • Individuals must be adults (aged 18-65)
  • Able to engage in physical activity (defined as walking two city blocks without stopping)
  • Individuals must also provide consent for the research team to contact their personal physician, if necessary, to provide clearance for the prescribed level of physical activity (i.e., walking) or to consult about rapid weight loss
  • Have moderate-to-high implicit preference for high-calorie foods
  • Satisfactory completion of all enrollment procedures]

Exclusion criteria:

  • Medical condition (e.g., cancer, type I diabetes, renal failure), heavy alcohol use, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
  • Recently began or changed the dosage of medication that can cause significant change in weight
  • History of bariatric surgery
  • Weight loss of ≥ 5% in the previous 3 months

Sites / Locations

  • Drexel UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Experimental

Experimental

Arm Label

Non-gamified program with sham ICT

Non-gamified program with Active ICT

Gamified program with sham ICT

Gamified program with Active ICT

Arm Description

One group will be assigned to a 12-month mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets (to align with neurotraining and promote autonomy , and behavioral strategies with sham.

One group will be assigned to a 12-month mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets (to align with neurotraining and promote autonomy , and behavioral strategies with active neurotraining.

One group will receive fully-gamified version of the program with a sham.

One group will receive fully-gamified version of the program with active neurotraining.

Outcomes

Primary Outcome Measures

Baseline Weight
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 1 month
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 6 months
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 12 months
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.

Secondary Outcome Measures

Caloric intake measured using the Fitbit app's built-in dietary tracking system
Caloric intake and intake of "red" (high calorie, "unhealthy") foods will be measured using the Fitbit app's built-in dietary tracking system and accompanying food item/calorie database. Foods tracked in Fitbit will be categorized as red foods based on their energy density.
Physical activity measured in minutes of moderate to vigorous physical activity using wrist-worn activity tracker.
Physical activity will be measured in minutes of moderate to vigorous physical activity using the Fitbit, a wrist-worn activity tracker.

Full Information

First Posted
May 27, 2022
Last Updated
September 5, 2023
Sponsor
Drexel University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05408494
Brief Title
Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program
Official Title
Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program: A 2 x 2 Randomized Design
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
Men in the United States have an exceptionally high prevalence of overweight and obesity, i.e., 71.3%, and 42% of men are currently attempting weight loss. However, men are dramatically underrepresented in weight loss programs. Attempts to modestly adapt standard weight loss programs have seen only minimal success. Mobile applications (mHealth apps) have attractive features, but have low male enrollment and poor efficacy as conventionally delivered. A gamified mHealth program offers the possibility of engaging men and enhancing efficacy given that (1) video gaming is highly appealing to men; (2) gamification features (e.g., digital rewards for attaining "streaks" and milestones, competition) are known enhance enjoyment and motivation and facilitate desired behaviors; and (3) "neurotraining" video games featuring repetitive action mechanics, adaptive difficulty, and feedback can train inhibitory control, a basic brain capacity to inhibit intrinsically-generated approach responses that is strongly linked to body mass and the consumption of high-calorie foods. This project evaluates long-term engagement and outcomes of a professionally-designed, game-based weight loss program. As such, 228 overweight men will be randomized to: (1) a 12-month mHealth weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets, physical activity and a control (sham) non-game neurotraining, or (2) a fully-gamified version of this same program, comprised of a behavior change program featuring team-based competition, digital reinforcers for attainment of streaks and milestones, and an integrated neurotraining video game. Aims include evaluating the efficacy of the gamified program in terms of weight loss, diet and physical activity at 12 months, as well as evaluating hypothesized mediators (inhibitory control and engagement), (enjoyment and compliance) and moderators (baseline frequency of video game play and implicit preferences for Inhibitory Control Training-targeted foods).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Utilizing a 2 x 2 factorial design, participants will be randomized to a mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets program alone or to a fully-gamified version of the program, comprised of a mobile behavior change program featuring team-based competition and digital reinforcers for attainment of streaks and milestones. Participants are also randomized to receive sham or active neurotraining, which will be integrated into the program they receive.
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be blind to condition.
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-gamified program with sham ICT
Arm Type
Sham Comparator
Arm Description
One group will be assigned to a 12-month mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets (to align with neurotraining and promote autonomy , and behavioral strategies with sham.
Arm Title
Non-gamified program with Active ICT
Arm Type
Active Comparator
Arm Description
One group will be assigned to a 12-month mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets (to align with neurotraining and promote autonomy , and behavioral strategies with active neurotraining.
Arm Title
Gamified program with sham ICT
Arm Type
Experimental
Arm Description
One group will receive fully-gamified version of the program with a sham.
Arm Title
Gamified program with Active ICT
Arm Type
Experimental
Arm Description
One group will receive fully-gamified version of the program with active neurotraining.
Intervention Type
Behavioral
Intervention Name(s)
Gamified behavioral weight loss treatment
Intervention Description
12-month mHealth fully-gamified version of the same program, comprised of a behavior change program with digital reinforcers for attainment of streaks and milestones, and an integrated neurotraining video game
Intervention Type
Behavioral
Intervention Name(s)
mHealth behavioral weight loss treatment
Intervention Description
a 12-month mHealth weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets, physical activity and a control (sham) non-game neurotraining
Primary Outcome Measure Information:
Title
Baseline Weight
Description
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Time Frame
Assessments will be administered at month zero.
Title
Change from Baseline Weight at 1 month
Description
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Time Frame
Assessment will be administered at month one.
Title
Change from Baseline Weight at 6 months
Description
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Time Frame
Assessment will be administered at month sixth.
Title
Change from Baseline Weight at 12 months
Description
Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Time Frame
Assessment will be administered at month twelve.
Secondary Outcome Measure Information:
Title
Caloric intake measured using the Fitbit app's built-in dietary tracking system
Description
Caloric intake and intake of "red" (high calorie, "unhealthy") foods will be measured using the Fitbit app's built-in dietary tracking system and accompanying food item/calorie database. Foods tracked in Fitbit will be categorized as red foods based on their energy density.
Time Frame
Assessments will be administered at months 0, 1, 6 and 12.
Title
Physical activity measured in minutes of moderate to vigorous physical activity using wrist-worn activity tracker.
Description
Physical activity will be measured in minutes of moderate to vigorous physical activity using the Fitbit, a wrist-worn activity tracker.
Time Frame
Assessments will be administered at months 0, 1, 6 and 12.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
All participants will identify as male.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Individuals must be of overweight or obese BMI (25-50 kg/m) Individuals must be adults (aged 18-65) Able to engage in physical activity (defined as walking two city blocks without stopping) Individuals must also provide consent for the research team to contact their personal physician, if necessary, to provide clearance for the prescribed level of physical activity (i.e., walking) or to consult about rapid weight loss Have moderate-to-high implicit preference for high-calorie foods Satisfactory completion of all enrollment procedures] Exclusion criteria: Medical condition (e.g., cancer, type I diabetes, renal failure), heavy alcohol use, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight Recently began or changed the dosage of medication that can cause significant change in weight History of bariatric surgery Weight loss of ≥ 5% in the previous 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael C Onu, B.S.
Phone
‪(267) 571-7917‬
Email
mo654@drexel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Evan M Forman, Ph.D.
Phone
215-553-7100
Email
wellcenter@drexel.edu
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Forman, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program

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