- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03236077
Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity
Study Overview
Detailed Description
This is a pilot intervention study with two groups: an intervention group (targeted exercise program for women with obesity and YMCA membership) and a control group (YMCA membership only). The targeted exercise program will be delivered by a YMCA and will be evaluated by our team. The majority of women who are recruited to this study will be randomized to receive the intervention or the control condition. However, we also have a small group of women who has been serving as our community advisory committee (CAC) that will also participate in the intervention classes and receive the membership. They will serve as pilot testers for our data collection methods and provide ongoing qualitative feedback on the intervention as part of their role in the CAC.
The study will take place in two phases at two different YMCAs (Ken-Ton and Independent Health) with approximately half of participants recruited for the first and the other half for the second.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14222
- University at Buffalo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- Aged 18-64
- BMI ≥ 30 (self-reported for initial screening and confirmed at informational session using direct measurement)
- Not currently participating in any regularly scheduled exercise (see definition in eligibility screener)
- Willing to come to the Ken-Ton YMCA 2-3x/week (Phase 1) or the Independent Health YMCA (Phase 2)
Exclusion Criteria:
- - Participants may not be pregnant or planning to become pregnant in the next 6 months
- Individuals with disabilities or health conditions that render them unable to participate in exercise or for whom exercise might be dangerous based on their answers to the Physical Activity Readiness Questionnaire or advisement form their physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
participate in a targeted exercise program at the YMCA.
Will include: Targeted exercise classes, Strength-training, Group support sessions
|
No Intervention: Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
YMCA attendance
Time Frame: 3 motnhs
|
YMCA attendance measured by swipes of member card
|
3 motnhs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MVPA
Time Frame: 3 months
|
Minutes/week of moderate-to-vigorous exercise measured via accelerometer
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Enjoyment
Time Frame: 3 months
|
Report greater enjoyment and acceptability of the exercise measured by the Physical Activity Enjoyment Scale (PACES)
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1134041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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