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Gamification for Obesity (STEP 4 Vets Trial)
N/A
Waitlist Available
Led By Amol S. Navathe, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Veterans receiving care at the CMCVAMC age 18 or older with a body mass index > 30
Veterans with a hypertension diagnosis and systolic blood pressure >140mm Hg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
STEP 4 Vets Trial Summary
This trial will compare the effectiveness of two different gamification approaches to encourage increased physical activity in Veterans. One encourages collaboration and the other encourages competition. The trial will also examine clinical outcomes, costs, barriers, and facilitators to implementation of the program within Veterans Affairs.
Who is the study for?
This trial is for Veterans aged 18 or older with obesity (BMI > 30) and high blood pressure (systolic >140mm Hg), who are interested in a 9-month physical activity program. It's not suitable for those already very active (over 7500 steps/day), in another study, unable to walk without help, or for whom the program is unsafe.Check my eligibility
What is being tested?
The trial tests two types of gamification designed using behavioral economics: one that encourages group collaboration and another that fosters competition among participants to increase their physical activity levels. The effectiveness, costs, and implementation within Veterans Affairs will be evaluated.See study design
What are the potential side effects?
Since this intervention involves increasing physical activity through gamified challenges rather than medication, side effects may include typical exercise-related issues such as muscle soreness or strain but should otherwise have minimal risks.
STEP 4 Vets Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran over 18, treated at CMCVAMC, with a BMI over 30.
Select...
I am a veteran diagnosed with high blood pressure above 140mm Hg.
STEP 4 Vets Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in physical activity
Secondary outcome measures
blood pressure
weight
STEP 4 Vets Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: gamification with competitionExperimental Treatment1 Intervention
participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on competition with each other
Group II: gamification with collaborationExperimental Treatment1 Intervention
participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on collaboration with each other
Group III: attention controlActive Control1 Intervention
participants receive a FitBit and set goals but do no other intervention
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,137 Total Patients Enrolled
40 Trials studying Obesity
9,628 Patients Enrolled for Obesity
Amol S. Navathe, MD PhDPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Scott R Greysen, MDPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran over 18, treated at CMCVAMC, with a BMI over 30.I need help to walk due to a medical condition.I am a veteran diagnosed with high blood pressure above 140mm Hg.I walk more than 7500 steps a day.
Research Study Groups:
This trial has the following groups:- Group 1: gamification with competition
- Group 2: gamification with collaboration
- Group 3: attention control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there availability for participants in this research?
"According to the research hosted on clinicaltrials.gov, recruitment for this trial has ceased since its last update on September 21st 2022. The original posting date was March 1st 2023. Fortunately, there are 1844 other studies that have open positions at present time."
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