Utilization of a Peer-Based Approach for the Promotion of Physical Activity in Inactive Women
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT05053113
- Status
- Recruiting
Conditions
- Obesity-Related Malignant Neoplasm
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Activity Monitor — DEVICEMonitor physical activity with FitBit
- Activity Monitor — DEVICEWear accelerometer
- Educational Intervention — OTHERReceive educational newsletter
- Survey Administration — OTHERAncillary studies
- Telephone-Based Intervention — BEHAVIORALReceive phone call from health coach
Study Details
This clinical trial tests the effect of a physical activity intervention that emphasizes support between partners in women who are not physically active. Decisions about and participation in physical activity often involve others in one's social circle, including family and friends. Social support for physical activity and having someone with whom to engage in physical activity may promote behavioral change and help increase moderate-intensity physical activity in inactive women.
Key Dates
- Start date
- Jul 27, 2022
- Status verified
- Apr 2026
- Primary completion
- Feb 2, 2027
- Completion
- Feb 2, 2027
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Group 1 (phone call, FitBit, newsletter, accelerometer)Participants receive phone calls over 30-45 minutes each from a health coach weekly during month 1, twice monthly during months 2-4, and monthly during months 5-6 for a total of 12 phone calls that focus on identifying needs, practicing autonomy supportive behaviors, and the development of a mutual support plan. Participants also engage in at least one physical activity per week with their partner and monitor their own and each other's activity using a FitBit. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days. Participants also receive an electronic newsletter twice monthly during months 1-3 and monthly during months 4-6 that provides educational physical activity-related information and tips for overcoming barriers to physical activity.
- Active Comparator: Group 2A (phone call, FitBit, newsletter, accelerometer)Participants receive phone calls from a health coach as in Intervention I that focus on providing support for behavioral skills, including monitoring physical activity, goal-setting, and problem-solving to overcome barriers to physical activity. Participants utilize a FitBit to monitor their physical activity and receive electronic newsletters twice monthly during months 1-3 and monthly during months 4-6 that provides educational physical activity-related information and tips for overcoming barriers to physical activity. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days.
- Active Comparator: Group 2B (FitBit, newsletter, accelerometer)Participants utilize a FitBit to monitor their physical activity and receive electronic newsletters twice monthly during months 1-3 and monthly during months 4-6 to share basic health education related to physical activity and provide support for engagement. Participants also wear an accelerometer for a minimum of 10 hours a day for 7 days.
Primary Outcome Measure
Change in objective minutes per week of moderate-intensity physical activity [ Time Frame: Through study completion, an average of 1 year ]
Central Contacts
- Larkin Strong713-563-8930
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | Larkin Strong (PRINCIPAL_INVESTIGATOR) |
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