NCT02529397

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

August 18, 2015

Last Update Submit

October 24, 2016

Conditions

Keywords

Working Memory Training, Weight Loss,

Outcome Measures

Primary Outcomes (1)

  • Weight

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

    24 weeks

Study Arms (2)

Adaptive Working Memory Training

EXPERIMENTAL

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

Non-adaptive Working Memory Training

PLACEBO COMPARATOR

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

Interventions

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.

Adaptive Working Memory 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.

Non-adaptive Working Memory Training

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Weight Management Program/Univ of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityWeight Loss

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Doris Ogden, MS

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 20, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations