Peer-Based Intervention for Inactive Women

Overseen By Larkin Strong

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Physical activity program, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Peer-Based Approach, Peer Support Intervention, Social Support Intervention, Partner-Based Physical Activity Intervention?

Research shows that peer support interventions can help improve physical activity and reduce body weight and waist circumference in adults. These interventions are effective because they provide social support and accountability, which can motivate people to adopt healthier behaviors. ^{1 2 3 4 5}

Is peer-based intervention generally safe for humans?

The research does not report any safety concerns for peer-based interventions, suggesting they are generally safe for humans. ^{3 4 6 7 8}

How is the Peer-Based Approach treatment different from other treatments for inactive women?

The Peer-Based Approach treatment is unique because it uses social support from peers to encourage physical activity, which can be more engaging and sustainable than traditional methods. This approach leverages the power of community and shared goals to motivate inactive women, making it distinct from other treatments that may not focus on peer interaction. ^{3 4 6 9 10}

Research Team

Larkin Strong

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for inactive women aged 18-65, who can partner with another eligible woman. Participants must be able to use a Fitbit and smartphone, have blood pressure below 160/100 mm Hg or medical clearance, live in the greater Houston area, and not be pregnant nor part of any other physical activity or weight loss study.

Inclusion Criteria

I identify as female.

Blood pressure reading < 160/100 mm Hg, or with medical clearance

Valid home address in the greater Houston area

Exclusion Criteria

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

Pregnancy or considering pregnancy during the study period, self-reported

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive phone calls from a health coach, engage in physical activities, and monitor activities using a FitBit and accelerometer. They also receive electronic newsletters.

6 months

12 phone calls, multiple physical activities

Follow-up

Participants are monitored for changes in physical activity at 6 and 12 months after baseline.

6 months

Follow-up assessments at 6 and 12 months

Treatment Details

Interventions

• Peer-Based Approach

Trial Overview The trial examines if having a support buddy increases physical activity among inactive women. It involves using an activity monitor like Fitbit, receiving educational materials on exercise, completing surveys about their habits, and getting support through phone calls.

Participant Groups

Group I: Group 1 (phone call, FitBit, newsletter, accelerometer) Experimental Treatment 4 Interventions

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 II: Group 2A (phone call, FitBit, newsletter, accelerometer) Active Control 4 Interventions

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 III: Group 2B (FitBit, newsletter, accelerometer) Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

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

Collaborator

Trials

1

Recruited

500+

Findings from Research

This study will evaluate whether breast cancer survivors (BCS) who receive 10 weeks of virtual support from qualified exercise professionals (QEP) will have increased exercise volume compared to those who do not receive such support, involving 108 participants matched in dyads.

The primary outcome is self-reported exercise volume, with secondary outcomes including device-measured exercise, social support, and health-related quality of life, aiming to determine the effectiveness of combining peer and professional support in enhancing exercise among BCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial. Smith-Turchyn, J., McCowan, ME., O'Loughlin, E., et al.[2021]

A study involving 161 inactive breast cancer survivors found that peer support through monthly phone calls or weekly text messages significantly improved physical activity maintenance at 12 months compared to a self-monitoring only group.

Both the Reach Plus Phone and Reach Plus Message interventions led to additional weekly moderate-to-vigorous physical activity, with the text message group showing the greatest increase, highlighting the effectiveness of ongoing peer support in sustaining physical activity after an initial intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Adoption and Maintenance Among Breast Cancer Survivors: A Randomized Trial of Peer Mentoring. Pinto, BM., Dunsiger, SI., Kindred, MM., et al.[2022]

Peer support can effectively enhance heart-healthy behaviors among women veterans at risk for cardiovascular disease, highlighting the importance of communal identity in health interventions.

Interviews with 25 women veterans revealed key factors for successful peer support, including shared goals, trust, compatibility in engagement levels, positivity, and accountability, suggesting that tailored peer matching and initial in-person interactions are crucial for building effective support relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding women veterans' preferences for peer support interventions to promote heart healthy behaviors: A qualitative study. Goldstein, KM., Zullig, LL., Oddone, EZ., et al.[2020]

The researchers developed a clear typology of peer-based intervention strategies aimed at promoting physical activity among older adults, addressing the need for consistent terminology and frameworks in this area.

They provided practical guidelines for designing and implementing these peer-based programs, which can help improve participation rates in physical activity among older adults by leveraging peer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-Based Strategies to Support Physical Activity Interventions for Older Adults: A Typology, Conceptual Framework, and Practice Guidelines. Matz-Costa, C., Howard, EP., Castaneda-Sceppa, C., et al.[2020]

Peer interventions can effectively reduce body weight, with an average decrease of 1.05 kg observed in a meta-analysis of 28 studies involving 7142 participants.

These interventions also led to a significant reduction in waist circumference and an increase in physical activity, although they did not significantly affect energy intake, indicating a potential benefit in managing obesity-related outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-supported lifestyle interventions on body weight, energy intake, and physical activity in adults: A systematic review and meta-analysis. Lim, S., Lee, WK., Tan, A., et al.[2021]

A peer support-based physical activity intervention significantly increased the proportion of sedentary women in Thiruvananthapuram, India, who became physically active, with 58.5% active at 4 months compared to only 10% in the control group.

The effectiveness of the intervention decreased over time, highlighting the importance of ongoing support and integration with community organizations to maintain physical activity levels after the intervention ends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a physical activity intervention program using peer support among sedentary women in Thiruvananthapuram City, India: results of a non-randomized quasi experimental study. Mathews, E., Sauzet, O., Thankappan, KR.[2022]

Peer-based health interventions have a long history but lack a comprehensive theoretical framework to describe their role and effectiveness in health promotion.

The proposed 2-step process for conceptualizing peer interventions includes establishing a theoretical focus (like education or social support) and identifying a theory that explains the impact of peer involvement, drawing from various psychological and social theories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer interventions to promote health: conceptual considerations. Simoni, JM., Franks, JC., Lehavot, K., et al.[2022]

Peer-based interventions can lead to small- to medium-sized improvements in health-related behaviors such as physical activity, smoking cessation, and condom use, based on a review of 25 randomized clinical trials.

However, the effectiveness of these interventions varied widely due to differences in study methods and other factors, and they did not significantly impact areas like breastfeeding or women's health screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of peer-based interventions on health-related behaviors in adults. Webel, AR., Okonsky, J., Trompeta, J., et al.[2022]

Involving peer volunteers in physical activity interventions for older adults can enhance social support and improve adherence, making the programs more effective.

Key facilitators for successful delivery include strong community connections and high-quality instructors, while challenges such as inconsistent practices and safety concerns need to be addressed for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and challenges in delivering a peer-support physical activity intervention for older adults: a qualitative study with multiple stakeholders. Crozier, A., Porcellato, L., Buckley, BJR., et al.[2021]

The study aims to test the feasibility of a peer-led physical activity intervention for older adults from socio-economically disadvantaged backgrounds, using a randomized controlled trial design over 12 weeks with follow-up at 6 months.

Data collected will assess recruitment, retention, and the effectiveness of the intervention in increasing moderate to vigorous physical activity, which is crucial for informing a larger definitive trial if the pilot proves successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walk with Me: a protocol for a pilot RCT of a peer-led walking programme to increase physical activity in inactive older adults. Tully, MA., Cunningham, C., Cupples, ME., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Physical Activity Adoption and Maintenance Among Breast Cancer Survivors: A Randomized Trial of Peer Mentoring. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Understanding women veterans' preferences for peer support interventions to promote heart healthy behaviors: A qualitative study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Peer-Based Strategies to Support Physical Activity Interventions for Older Adults: A Typology, Conceptual Framework, and Practice Guidelines. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Peer-supported lifestyle interventions on body weight, energy intake, and physical activity in adults: A systematic review and meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a physical activity intervention program using peer support among sedentary women in Thiruvananthapuram City, India: results of a non-randomized quasi experimental study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Peer interventions to promote health: conceptual considerations. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of peer-based interventions on health-related behaviors in adults. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Facilitators and challenges in delivering a peer-support physical activity intervention for older adults: a qualitative study with multiple stakeholders. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Walk with Me: a protocol for a pilot RCT of a peer-led walking programme to increase physical activity in inactive older adults. [2022]