ObesityNCT03693859
Smart Gaming in Obesity
A study testing Cognitive enhancement program and Behavioral Weight Loss + Health Segments in people with Obesity, run by Philadelphia College of Osteopathic Medicine.
Trial summary
Obesity (Body Mass Index ≥ 30 kg/m2) is associated with diminished executive functioning. The primary objective of this randomized, controlled trial is to evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming on weight loss and weight loss… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Cognitive enhancement program and Behavioral Weight Loss + Health Segments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Sep 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obesity
- Executive functioning deficits
- Internet access
Who cannot join
- Under 18 years of age
- Over 65 years of age
- Taking weight loss medication
- Pregnant
About this study
Official title: Smart Gaming for Obesity: A Randomized Trial
Obesity (Body Mass Index ≥ 30 kg/m2) is associated with diminished executive functioning. The primary objective of this randomized, controlled trial is to evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming on weight loss and weight loss maintenance in adults with obesity and executive functioning deficits compared to adults undergoing standard behavioral treatment alone (N = 200). Serious gaming interventions that target the specific cognitive functions needed for weight-loss maintenance may improve long-term weight-loss success.
Read the detailed description
This randomized, controlled study will evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming (BWL+GAMING) on weight loss and maintenance in adults with obesity and executive functioning deficits compared to standard behavioral treatment alone (BWL) at two urban Philadelphia university-based clinics (PCOM [Philadelphia College of Osteopathic Medicine] and Temple University). Participants will be recruited from the community. All participants (N = 200) will complete 12 weeks of behavioral weight loss treatment. Intervention participants will also complete 30-minutes (5 days per week for 8 weeks) of a serious gaming program, which will feature online games developed specifically to enhance executive functions. The primary outcomes are weight change and weight change maintenance, which will be measured at 12 and 52 weeks, respectively. Neuropsychological testing will evaluate the proposed mechanism of action, changes in executive functioning, before and after treatment (12 and 52 weeks).
- Conditions
- Obesity
- Being tested
- Cognitive enhancement program, Behavioral Weight Loss + Health Segments
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive enhancement programBehavioural
Also called Smart Gaming
The cognitive enhancement condition (BWL+GAMING) will both teach the behavioral skills necessary for weight loss and strengthen the executive functions that underlie these skills.
Behavioral Weight Loss + Health SegmentsBehavioural
Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss + Gaming | Experimental | Treatment will consist of 12-weekly, one-hour group sessions of approximately 15 participants per group. Participants will provide logs of serious gaming (intervention). Receives: Behavioral: Cognitive enhancement program |
| Behavioral Weight Loss + Health Segments | Active comparator | Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks. Participants will provide logs of video segment watching (control). Receives: Behavioral: Behavioral Weight Loss + Health Segments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight change maintenance of at least 5%
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study startOct 2019 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philadelphia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693859
- Sponsor's protocol ID
- Lent1018
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Gaming for Obesity: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03693859
- Acronym / sponsor ID
- Lent1018
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Philadelphia College of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 3 Oct 2018 (actual)
- 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.
Obesity (Body Mass Index ≥ 30 kg/m2) is associated with diminished executive functioning. The primary objective of this randomized, controlled trial is to evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming on weight loss and weight loss maintenance in adults with obesity and executive functioning deficits compared to adults undergoing standard behavioral treatment alone (N = 200). Serious gaming interventions that target the specific cognitive functions needed for weight-loss maintenance may improve long-term weight-loss success.
Detailed description
This randomized, controlled study will evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming (BWL+GAMING) on weight loss and maintenance in adults with obesity and executive functioning deficits compared to standard behavioral treatment alone (BWL) at two urban Philadelphia university-based clinics (PCOM [Philadelphia College of Osteopathic Medicine] and Temple University). Participants will be recruited from the community. All participants (N = 200) will complete 12 weeks of behavioral weight loss treatment. Intervention participants will also complete 30-minutes (5 days per week for 8 weeks) of a serious gaming program, which will feature online games developed specifically to enhance executive functions. The primary outcomes are weight change and weight change maintenance, which will be measured at 12 and 52 weeks, respectively. Neuropsychological testing will evaluate the proposed mechanism of action, changes in executive functioning, before and after treatment (12 and 52 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss + Gaming | Experimental | Behavioral: Cognitive enhancement programTreatment will consist of 12-weekly, one-hour group sessions of approximately 15 participants per group. Participants will provide logs of serious gaming (intervention). |
| Behavioral Weight Loss + Health Segments | Active comparator | Behavioral: Behavioral Weight Loss + Health SegmentsControl participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks. Participants will provide logs of video segment watching (control). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obesity
- Executive functioning deficits
- Internet access
Key exclusion criteria (4 listed)
- Under 18 years of age
- Over 65 years of age
- Taking weight loss medication
- Pregnant
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 |
|---|---|---|
| Cognitive enhancement programAlso: Smart GamingThe cognitive enhancement condition (BWL+GAMING) will both teach the behavioral skills necessary for weight loss and strengthen the executive functions that underlie these skills. | Behavioural | Behavioral Weight Loss + Gaming |
| Behavioral Weight Loss + Health SegmentsControl participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks. | Behavioural | Behavioral Weight Loss + Health Segments |
Primary outcome
Weight change
Time frame: 52 weeks
Weight change maintenance of at least 5%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive enhancement program and Behavioral Weight Loss + Health Segments in people with Obesity, run by Philadelphia College of Osteopathic Medicine.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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 change (time frame: 52 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 4 Oct 2018.