Clinical trial NCT05053113: Utilization of a Peer-Based Approach for the Promotion of Physical Activity in Inactive Women
Official title: A Peer-Based Approach to Enhance Physical Activity in Dyads of Inactive Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity-Related Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute should be included as a Collaborator.
First posted: 2021-09-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVE:

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.

Eligibility criteria: Inclusion Criteria:

* Self-identify as female
* 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:

* Pregnancy or considering pregnancy during the study period, self-reported
* 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

Primary outcomes:
measure: Change in objective minutes per week of moderate-intensity physical activity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Larkin Strong
role: PRINCIPAL_INVESTIGATOR
References: