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 — DEVICE
    Monitor physical activity with FitBit
  • Activity Monitor — DEVICE
    Wear accelerometer
  • Educational Intervention — OTHER
    Receive educational newsletter
  • Survey Administration — OTHER
    Ancillary studies
  • Telephone-Based Intervention — BEHAVIORAL
    Receive 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

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Larkin Strong
713-563-8930
Larkin Strong (PRINCIPAL_INVESTIGATOR)

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