Utilization of a Peer-Based Approach for the Promotion of Physical Activity in Inactive Women
NCT ID: NCT05053113
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2022-07-27
2027-02-02
Brief Summary
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Detailed Description
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I. Determine whether the dyadic behavioral intervention produces greater engagement of moderate-intensity objective physical activity (PA) compared with the individual behavioral intervention.
SECONDARY OBJECTIVES:
I. Determine the effects of the dyadic behavioral intervention on hypothesized intervention mechanisms (e.g., autonomous motivation, social support, autonomy support, self-efficacy), and the associations of those mechanisms with PA outcomes.
II. Determine the effects of the dyadic behavioral intervention on secondary outcomes (i.e., self-reported moderate-intensity PA, lower body strength, blood pressure, anthropometric measures, mean daily steps, sedentary time) compared with the individual behavioral intervention.
III. Determine whether the dyadic behavioral intervention produces greater engagement of moderate-intensity PA compared with the individual control.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP 1 (DYADIC INTERVENTION): 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.
GROUP 2 (INDIVIDUAL CONDITION): Participants are assigned to one of 2 groups.
GROUP 2A (INDIVIDUAL INTERVENTION): 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.
GROUP 2B (HEALTH EDUCATION CONTROL): 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.
At completion of study, patients are followed up at 6 and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Activity Monitor
Monitor physical activity with FitBit
Activity Monitor
Wear accelerometer
Educational Intervention
Receive educational newsletter
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive phone call from health coach
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.
Activity Monitor
Monitor physical activity with FitBit
Activity Monitor
Wear accelerometer
Educational Intervention
Receive educational newsletter
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive phone call from health coach
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.
Activity Monitor
Monitor physical activity with FitBit
Activity Monitor
Wear accelerometer
Educational Intervention
Receive educational newsletter
Survey Administration
Ancillary studies
Interventions
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Activity Monitor
Monitor physical activity with FitBit
Activity Monitor
Wear accelerometer
Educational Intervention
Receive educational newsletter
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive phone call from health coach
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years
* Speak English or Spanish
* Physically able to engage in low-to-moderate PA as assessed by the PA Readiness Questionnaire (PAR-Q), or with medical clearance
* Insufficient self-reported moderate-to-vigorous PA (\< 150 minutes/week)
* Able to enroll with one eligible adult female partner
* Valid home address in the greater Houston area
* Have a functioning smartphone and able and willing to send and receive text messages
* Willing to use the Fitbit app and device
* Blood pressure reading \< 160/100 mm Hg, or with medical clearance
Exclusion Criteria
* Currently participating in a program or research study to promote physical activity or weight loss
* Plans to move outside the greater Houston area during the study period
18 Years
65 Years
FEMALE
Yes
Sponsors
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National Heart, Lung, and Blood Institute should be included as a Collaborator.
UNKNOWN
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Larkin Strong
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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M.D. Anderson Cancer Center
Other Identifiers
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NCI-2020-13914
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0809
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0809
Identifier Type: -
Identifier Source: org_study_id
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