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

NCT05053113 | Recruiting

• 3 other identifiers: 2020-0809NCI-2020-13914R01HL155310
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity-Related Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1 (phone call, FitBit, newsletter, accelerometer)

EXPERIMENTAL

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.

Device: Activity Monitor; Other: Educational Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention

Group 2A (phone call, FitBit, newsletter, accelerometer)

ACTIVE COMPARATOR

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.

Device: Activity Monitor; Other: Educational Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention

Group 2B (FitBit, newsletter, accelerometer)

ACTIVE COMPARATOR

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.

Device: Activity Monitor; Other: Educational Intervention; Other: Survey Administration

Interventions

Activity Monitor DEVICE

Monitor physical activity with FitBit

Also known as: Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device

Group 1 (phone call, FitBit, newsletter, accelerometer); Group 2A (phone call, FitBit, newsletter, accelerometer); Group 2B (FitBit, newsletter, accelerometer)

Educational Intervention OTHER

Receive educational newsletter

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group 1 (phone call, FitBit, newsletter, accelerometer); Group 2A (phone call, FitBit, newsletter, accelerometer); Group 2B (FitBit, newsletter, accelerometer)

Survey Administration OTHER

Ancillary studies

Group 1 (phone call, FitBit, newsletter, accelerometer); Group 2A (phone call, FitBit, newsletter, accelerometer); Group 2B (FitBit, newsletter, accelerometer)

Telephone-Based Intervention BEHAVIORAL

Receive phone call from health coach

Group 1 (phone call, FitBit, newsletter, accelerometer); Group 2A (phone call, FitBit, newsletter, accelerometer)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute should be included as a Collaborator.: collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M.D. Anderson Cancer Center

MeSH Terms

Interventions

Fitness Trackers; Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Larkin Strong

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larkin Strong

CONTACT

713-563-8930; LLStrong@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 22, 2021
• Study Start: July 27, 2022
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)