← Back to Search

Peer-Based Intervention for Inactive Women

N/A

Recruiting

Led By Larkin Strong

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-identify as female

Age 18-65 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is testing whether having a support partner makes women more likely to be physically active.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

There are no direct medical side effects from participating as this isn't a drug trial. However, participants may experience general discomforts associated with starting new physical activities such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I identify as female.

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in objective minutes per week of moderate-intensity physical activity

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 (phone call, FitBit, newsletter, accelerometer)Experimental Treatment4 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 Control4 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 Control3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Activity Monitor

2013

N/A

~320

Telephone-Based Intervention

2017

Completed Phase 2

~3400

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,786,817 Total Patients Enrolled

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

Larkin StrongPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

740 Total Patients Enrolled

Media Library

Peer-Based Approach Clinical Trial Eligibility Overview. Trial Name: NCT05053113 — N/A

Cancer Clinical Trial 2023: Peer-Based Approach Highlights & Side Effects. Trial Name: NCT05053113 — N/A

Peer-Based Approach 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053113 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment available to individuals aged fifty and beyond?

"This clinical trial is only open for individuals aged 18 to 65. However, there are 300 medical trials catered specifically towards minors and 2205 that address the needs of elderly patients."

Answered by AI

Are there still opportunities to join this clinical trial?

"According to clinicaltrials.gov, this particular medical trial is currently not enrolling patients. The study was initially launched on September 30th 2022 and last updated on May 11th 2022; however, there are 2390 other trials actively seeking participants right now."

Answered by AI

Who has the opportunity to participate in this clinical research?

"To qualify for enrollment, applicants must have malignant neoplasms and be between 18-65 years old. This clinical trial has space for 500 volunteers in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Utilization of a Peer-Based Approach for the Promotion of Physical Activity in Inactive Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05053113.