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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02529397
Other study ID # CHRBBS: 15-647
Secondary ID
Status Completed
Phase N/A
First received August 18, 2015
Last updated October 24, 2016
Start date October 2015
Est. completion date May 2016

Study information

Verified date October 2016
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Behavioral Weight Management Program/Univ of Vermont Burlington Vermont

Sponsors (1)

Lead Sponsor Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Participants weight at baseline will be compared to their weight at 24 weeks at the completion of the study. 24 weeks No
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