Recruiting

Physical Activity

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05053113

Conditions

Obesity-Related Malignant Neoplasm

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Activity Monitor

Activity Monitor

Educational Intervention

Survey Administration

Telephone-Based Intervention

Study Details

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

Study ID

NCT05053113

Start date

Jul 27, 2022

Status verified date

Apr, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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

Primary outcome measure

  • Change in objective minutes per week of moderate-intensity physical activity [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Larkin Strong

713-563-8930LLStrong@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Larkin Strong

713-563-8930LLStrong@mdanderson.org

Principal Investigator:

Larkin Strong

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-04.