ADHDFocusNCT02529397
Obesity Treatment Enhanced With Working Memory Training
A study testing Adaptive Working Memory Training and Non-adaptive cognitive training in people with ADHD and Weight Loss, run by University of Vermont at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ADHD, Weight Loss
- What is being tested?
- Adaptive Working Memory Training and Non-adaptive cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Weight Management Program/Univ of Vermont
Burlington, Vermont, 05405
About this study
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.
Read the 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.
- Conditions
- ADHD, Weight Loss
- Being tested
- Adaptive Working Memory Training, Non-adaptive cognitive training
- Keywords
- Working Memory Training, Weight Loss,
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Working Memory TrainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Non-adaptive cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Participants weight at baseline will be compared to their weight at 24 weeks at the completion of the study.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean R. Harvey, PhD, RD, University of Vermont
- Investigators
- Doris Ogden, MS, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529397
- Sponsor's protocol ID
- CHRBBS: 15-647
- Acronym
- Focus
- Status last verified
- Oct 2016
- First submitted
- 18 Aug 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Treatment Enhanced With Working Memory Training
- ClinicalTrials.gov ID
- NCT02529397
- Acronym / sponsor ID
- Focus / CHRBBS: 15-647
- Conditions
- ADHD, Weight Loss
- Keywords
- Working Memory Training, Weight Loss,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Working Memory Training | Experimental | Behavioral: Adaptive Working Memory TrainingThe 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. |
| Non-adaptive Working Memory Training | Placebo comparator | Behavioral: Non-adaptive cognitive trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Working Memory TrainingParticipants 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. | Behavioural | Adaptive Working Memory Training |
| Non-adaptive cognitive trainingParticipants 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. | Behavioural | Non-adaptive Working Memory Training |
Primary outcome
Weight
Time frame: 24 weeks
Participants weight at baseline will be compared to their weight at 24 weeks at the completion of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Ogden, MS principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Working Memory Training and Non-adaptive cognitive training in people with ADHD and Weight Loss, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.