Focus: Obesity Treatment Enhanced With Working Memory Training

Sponsor

University of Vermont (Other)

Overall Status

Completed

CT.gov ID

NCT02529397

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine the effects of providing subjects who have attention deficits, with or without a formal diagnosis of attention deficit hyperactivity disorder (ADHD), with Working Memory computerized training and explore whether this training is a feasible way to help them better engage in a weight loss treatment program, thereby enhancing weight loss results. Half of the participants will receive five weeks of online adaptive WM training concurrently while attending an in-person 24-week behavioral weight management program and half will receive five weeks of a non-adaptive form of cognitive training concurrently while attending a 24-week behavioral weight management program in person.

Condition or Disease	Intervention/Treatment	Phase
ADHD Weight Loss	Behavioral: Adaptive Working Memory Training Behavioral: Non-adaptive cognitive training	N/A

Detailed Description

Populations with ADHD or attention issues tend to have more weight loss attempts, struggle more with losing weight, and drop out of treatment more frequently than those without attention difficulties. Adaptive working memory training has been used to strengthen working memory and to mediate the symptoms associated with ADHD. The adaptive training becomes progressively more challenging as participants master each level of the training, while non-adaptive training remains at the same level throughout. Both groups will attend 24 weekly, in-person weight management classes on the University of Vermont Campus. Both groups will do cognitive training on their own home computers five days a week for 30-40 minutes for five weeks concurrently while engaged in the weight loss program.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Obesity Treatment Enhanced With Working Memory Training

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adaptive Working Memory Training The experimental group will receive working memory training through a commercial computerized program: five weeks of adaptive working memory training concurrently with a behavioral weight loss program. Adaptive working memory training becomes progressively more challenging depending on an individual's performance on a given task. They will attend weekly classes of a behavioral weight loss program.	Behavioral: Adaptive Working Memory Training Participants will train for 30-40 minutes per day, five days per week at home for 5 weeks using an adaptive cognitive training program which becomes increasingly challenging as the participant masters each level. Behavioral classes will teach the principles of weight management and exercise.
Placebo Comparator: Non-adaptive Working Memory Training The control group will receive five weeks of non-adaptive (placebo) cognitive training concurrent with the identical behavioral weight loss program as in the experimental group. Non-adaptive cognitive training remains at a constant level.	Behavioral: Non-adaptive cognitive training Participants will train for 30-40 minutes per day, five days per week at home for 5 weeks using a non-adaptive cognitive training program. Behavioral classes will teach the principles of weight management and exercise.

Arm

Intervention/Treatment

Experimental: Adaptive Working Memory Training

The experimental group will receive working memory training through a commercial computerized program: five weeks of adaptive working memory training concurrently with a behavioral weight loss program. Adaptive working memory training becomes progressively more challenging depending on an individual's performance on a given task. They will attend weekly classes of a behavioral weight loss program.

Behavioral: Adaptive Working Memory Training

Participants will train for 30-40 minutes per day, five days per week at home for 5 weeks using an adaptive cognitive training program which becomes increasingly challenging as the participant masters each level. Behavioral classes will teach the principles of weight management and exercise.

Placebo Comparator: Non-adaptive Working Memory Training

The control group will receive five weeks of non-adaptive (placebo) cognitive training concurrent with the identical behavioral weight loss program as in the experimental group. Non-adaptive cognitive training remains at a constant level.

Behavioral: Non-adaptive cognitive training

Participants will train for 30-40 minutes per day, five days per week at home for 5 weeks using a non-adaptive cognitive training program. Behavioral classes will teach the principles of weight management and exercise.

Outcome Measures

Primary Outcome Measures

Weight [24 weeks]
Participants weight at baseline will be compared to their weight at 24 weeks at the completion of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Must score 4 or higher on the ASRS v. 1.1
Must live within 45 minutes driving distance from UVM campus
Must be able to exercise
Must have a computer with internet access and ability to utilize flash
Must be 18 or older

Exclusion Criteria:

Health issues that preclude exercise
use of medications that interfere with the ability to lose weight
vacation longer than two weeks
current participation in another weight loss program
reside more than 45 minutes from UVM campus in Burlington
no internet access, no home computer, or computer cannot use flash

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Behavioral Weight Management Program/Univ of Vermont	Burlington	Vermont	United States	05405

Sponsors and Collaborators

University of Vermont

Investigators

Principal Investigator: Doris Ogden, MS, University of Vermont

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jean R. Harvey, PhD, RD, Professor and Chair, University of Vermont

ClinicalTrials.gov Identifier:

NCT02529397

Other Study ID Numbers:

CHRBBS: 15-647

First Posted:

Aug 20, 2015

Last Update Posted:

Oct 25, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Jean R. Harvey, PhD, RD, Professor and Chair, University of Vermont

Working Memory Training, Weight Loss,

Additional relevant MeSH terms:

Weight Loss

Study Results

No Results Posted as of Oct 25, 2016