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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity-Related Malignant Neoplasm
• Intervention / Treatment: Other: Survey Administration; Device: Activity Monitor; Device: Activity Monitor; Other: Educational Intervention; Behavioral: Telephone-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larkin Strong; Phone Number: 713-563-8930; Email: LLStrong@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Principal Investigator: Larkin Strong
      • Contact: Larkin Strong; Phone Number: 713-563-8930; Email: LLStrong@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Survey Administration; Ancillary studies; Device: Activity Monitor; Monitor physical activity with FitBit; Other Names: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device; Device: Activity Monitor; Wear accelerometer; Other Names: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device; Other: Educational Intervention; Receive educational newsletter; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Telephone-Based Intervention; Receive phone call from health coach
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.	Other: Survey Administration; Ancillary studies; Device: Activity Monitor; Monitor physical activity with FitBit; Other Names: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device; Device: Activity Monitor; Wear accelerometer; Other Names: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device; Other: Educational Intervention; Receive educational newsletter; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Telephone-Based Intervention; Receive phone call from health coach
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.	Other: Survey Administration; Ancillary studies; Device: Activity Monitor; Monitor physical activity with FitBit; Other Names: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device; Device: Activity Monitor; Wear accelerometer; Other Names: Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device; Other: Educational Intervention; Receive educational newsletter; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in objective minutes per week of moderate-intensity physical activity	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.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Heart, Lung, and Blood Institute should be included as a Collaborator.
• Investigators: Principal Investigator: Larkin Strong, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Investigative Techniques; Equipment and Supplies; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Electrical Equipment and Supplies; Diagnostic Equipment; Wearable Electronic Devices; Methods; Early Intervention, Educational; Educational Status; Fitness Trackers
• Other Study ID Numbers: 2020-0809 (Other Identifier: M D Anderson Cancer Center); NCI-2020-13914 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01HL155310 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No