NCT03693859

Brief Summary

Obesity (Body Mass Index ≥ 30 kg/m2) is associated with diminished executive functioning. The primary objective of this randomized, controlled trial is to evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming on weight loss and weight loss maintenance in adults with obesity and executive functioning deficits compared to adults undergoing standard behavioral treatment alone (N = 200). Serious gaming interventions that target the specific cognitive functions needed for weight-loss maintenance may improve long-term weight-loss success.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

October 1, 2018

Last Update Submit

October 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Weight change maintenance of at least 5%

    52 weeks

Study Arms (2)

Behavioral Weight Loss + Gaming

EXPERIMENTAL

Treatment will consist of 12-weekly, one-hour group sessions of approximately 15 participants per group. Participants will provide logs of serious gaming (intervention).

Behavioral: Cognitive enhancement program

Behavioral Weight Loss + Health Segments

ACTIVE COMPARATOR

Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks. Participants will provide logs of video segment watching (control).

Behavioral: Behavioral Weight Loss + Health Segments

Interventions

The cognitive enhancement condition (BWL+GAMING) will both teach the behavioral skills necessary for weight loss and strengthen the executive functions that underlie these skills.

Also known as: Smart Gaming
Behavioral Weight Loss + Gaming

Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks.

Behavioral Weight Loss + Health Segments

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obesity
  • Executive functioning deficits
  • Internet access

You may not qualify if:

  • Under 18 years of age
  • Over 65 years of age
  • Taking weight loss medication
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

October 1, 2019

Primary Completion

October 1, 2022

Study Completion

September 1, 2023

Last Updated

October 4, 2018

Record last verified: 2018-10