Obesity-Related Malignant NeoplasmNCT05053113
Utilization of a Peer-Based Approach for the Promotion of Physical Activity in Inactive Women
A study testing Activity Monitor, Educational Intervention and Survey Administration in people with Obesity-Related Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity-Related Malignant Neoplasm
- What is being tested?
- Activity Monitor, Educational Intervention and Survey Administration
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine whether the dyadic behavioral intervention produces greater engagement of moderate-intensity objective physical activity (PA) compared with the individual behavioral intervention.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Obesity-Related Malignant Neoplasm
- Being tested
- Activity Monitor, Educational Intervention, Survey Administration, Telephone-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity MonitorDevice
Also called Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device
Monitor physical activity with FitBit
Activity MonitorDevice
Also called Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device
Wear accelerometer
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational newsletter
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive phone call from health coach
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Activity Monitor; Other: Educational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start27 Jul 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity-Related Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute should be included as a Collaborator.
- Responsible party
- Sponsor
- Investigators
- Larkin Strong, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053113
- Sponsor's protocol ID
- 2020-0809
- Other IDs
- NCI-2020-13914, 2020-0809, R01HL155310
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer-Based Approach to Enhance Physical Activity in Dyads of Inactive Women
- ClinicalTrials.gov ID
- NCT05053113
- Acronym / sponsor ID
- 2020-0809
- Conditions
- Obesity-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 460 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute should be included as a Collaborator.
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine whether the dyadic behavioral intervention produces greater engagement of moderate-intensity objective physical activity (PA) compared with the individual behavioral intervention.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (phone call, FitBit, newsletter, accelerometer) | Experimental | Device: Activity Monitor, Other: Educational Intervention, Other: Survey Administration, Behavioral: Telephone-Based InterventionParticipants 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 2A (phone call, FitBit, newsletter, accelerometer) | Active comparator | Device: Activity Monitor, Other: Educational Intervention, Other: Survey Administration, Behavioral: Telephone-Based InterventionParticipants 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 (FitBit, newsletter, accelerometer) | Active comparator | Device: Activity Monitor, Other: Educational Intervention, Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity MonitorAlso: Activity Tracker, Activity Tracker Device, Physical Activity Measuring DeviceMonitor physical activity with FitBit | Device | Group 1 (phone call, FitBit, newsletter, accelerometer), Group 2A (phone call, FitBit, newsletter, accelerometer), Group 2B (FitBit, newsletter, accelerometer) |
| Activity MonitorAlso: Activity Tracker, Activity Tracker Device, Physical Activity Measuring DeviceWear accelerometer | Device | Group 1 (phone call, FitBit, newsletter, accelerometer), Group 2A (phone call, FitBit, newsletter, accelerometer), Group 2B (FitBit, newsletter, accelerometer) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational newsletter | Other | Group 1 (phone call, FitBit, newsletter, accelerometer), Group 2A (phone call, FitBit, newsletter, accelerometer), Group 2B (FitBit, newsletter, accelerometer) |
| Survey AdministrationAncillary studies | Other | Group 1 (phone call, FitBit, newsletter, accelerometer), Group 2A (phone call, FitBit, newsletter, accelerometer), Group 2B (FitBit, newsletter, accelerometer) |
| Telephone-Based InterventionReceive phone call from health coach | Behavioural | Group 1 (phone call, FitBit, newsletter, accelerometer), Group 2A (phone call, FitBit, newsletter, accelerometer) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- M.D. Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larkin Strong principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Monitor, Educational Intervention and Survey Administration in people with Obesity-Related Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in objective minutes per week of moderate-intensity physical activity (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.