- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02529397
Obesity Treatment Enhanced With Working Memory Training (Focus)
October 24, 2016 updated by: Jean R. Harvey, PhD, RD, University of Vermont
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vermont
-
Burlington, Vermont, United States, 05405
- Behavioral Weight Management Program/Univ of Vermont
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: 24 weeks
|
Participants weight at baseline will be compared to their weight at 24 weeks at the completion of the study.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Doris Ogden, MS, University of Vermont
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
August 18, 2015
First Submitted That Met QC Criteria
August 18, 2015
First Posted (Estimate)
August 20, 2015
Study Record Updates
Last Update Posted (Estimate)
October 25, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRBBS: 15-647
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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