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NCT Number: NCT05053113

Utilization of a Peer-Based Approach for the Promotion of Physical Activity in Inactive Women

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Larkin Strong

CONTACT

[email protected]

713-563-8930

Larkin Strong

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity monitor

Device

Monitor physical activity with FitBit

Other names: Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device

Educational Intervention

Other

Receive educational newsletter

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Survey Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive phone call from health coach

Primary outcomes

  1. Change in objective minutes per week of moderate-intensity physical activity

    Time frame: Through study completion, an average of 1 year

    Will use a linear mixed model (LMM) analysis, which includes the intervention as a fixed effect predictor and a dyad-specific random intercept to account for the dependent nature of the nested design (in the dyadic intervention group) to assess if the dyadic intervention led to increased moderate-intensity physical activity, relative to the individual intervention. will also assess changes in physical activity across time (i.e., at 6 and 12 months after baseline) using longitudinal data, where both within-dyad and within-subject (repeated measures across time points) correlations will be accounted for. Relevant covariates (e.g., age, race/ethnicity, dyad relationship, education, household income and composition, employment status, neighborhood environmental characteristics) will be adjusted for in the analysis. Potential effect modifiers, e.g., depressive symptoms, perceived stress, neighborhood environmental characteristics, will be explored.

Study contacts

Contact information is provided by the study sponsor or research team.

Larkin Strong

CONTACT

[email protected]

713-563-8930

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute should be included as a Collaborator.

Registry information

Official study title

A Peer-Based Approach to Enhance Physical Activity in Dyads of Inactive Women

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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