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Social Networks to Promote Physical Activity

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ClinicalTrials.gov Identifier: NCT03199196
Recruitment Status : Active, not recruiting
First Posted : June 26, 2017
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this research study is to learn if enrolling in a program with a partner that involves monitoring each other's physical activity and providing support to one another can help both participants be more physically active.

Condition or disease Intervention/treatment Phase
Cancer Prevention Device: Activity Tracker Device: Smartphone Application Behavioral: Questionnaires Behavioral: Focus Group Behavioral: Electronic Newsletters Behavioral: Telephone Counseling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Social Networks to Promote Physical Activity in African American and Hispanic Women
Actual Study Start Date : May 2, 2014
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 - Intervention

Participants given an activity tracker at the given an accelerometer at each visit. Participants instructed in use of a smartphone application at the baseline visit.

Participant emailed electronic newsletters to read that may help participant be more physically active.

Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).

Study visits performed 2 times (1 time at the beginning of the study, and 1 time 16 weeks after beginning the study).

Participants complete questionnaires 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.

Participants invited to take part in a final focus group sometime after the 16-week visit.

Device: Activity Tracker

Group 1 - Intervention: Participants given an accelerometer at each visit. Participant wears the accelerometer for 7 days.

Group 2 - Newsletters: After completing the 16 week visit, participant given an activity tracker.


Device: Smartphone Application

Group 1 - Intervention: Participant given smartphone application baseline visit to track physical activity, connect with participant's partner to share information about participant's physical activity, and provide support to partner to be more physically active.

Group 2 - Newsletters: After completing the 16 week visit, participant given instruction in the use of a smartphone application.


Behavioral: Questionnaires
Participants complete questionnaires about feelings, moods, motivation for physical activity, any social support received from others, the neighborhood participant lives in, and other physical activity-related topics. Questionnaires completed 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.The questionnaires should take about 45 minutes to complete.
Other Name: Surveys

Behavioral: Focus Group
Participants invited to take part in a final focus group. Focus group takes place sometime after the 16-week visit. Focus groups/interviews are audio recorded.

Behavioral: Electronic Newsletters
Participant emailed electronic newsletters to read that may help participant be more physically active.

Behavioral: Telephone Counseling
Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).

Group 2 - Control

Participants sent electronic newsletters throughout the study that may help participant be more physically active.

Study visits performed 2 times (1 time at the beginning of the study, and 1 time 16 weeks after beginning the study).

Participants complete questionnaires 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.

Participants invited to take part in a final focus group sometime after the 16-week visit.

Behavioral: Questionnaires
Participants complete questionnaires about feelings, moods, motivation for physical activity, any social support received from others, the neighborhood participant lives in, and other physical activity-related topics. Questionnaires completed 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.The questionnaires should take about 45 minutes to complete.
Other Name: Surveys

Behavioral: Focus Group
Participants invited to take part in a final focus group. Focus group takes place sometime after the 16-week visit. Focus groups/interviews are audio recorded.

Behavioral: Electronic Newsletters
Participant emailed electronic newsletters to read that may help participant be more physically active.




Primary Outcome Measures :
  1. Women's Preferences for a Physical Activity (PA) Promotion Intervention [ Time Frame: 16 weeks ]
    Women's preferences for a physical activity (PA) promotion intervention determined by focus groups.


Secondary Outcome Measures :
  1. Feasibility of a Social Network-Based Physical Activity (PA) Intervention in Sedentary Women Who are Primarily African American (AA) and Hispanic [ Time Frame: 16 weeks ]
    Study considered feasible only if recruitment and retention percentages reach the lower bound of the one-sided 90% confidence intervals of the target unless there are convincing arguments they can be improved sufficiently by modifying recruitment or retention strategies.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Self-reported AA race or Hispanic ethnicity (all participants except partners)
  2. Age 25-60 years
  3. Able to speak English and read at a sixth grade level (as indicated by a score of at least 7 on the Rapid Estimate of Adult Literacy in Medicine, revised [REALM-R]; (Intervention study participants only)
  4. Physically able to engage in low-to-moderate PA as assessed by the PA Readiness Questionnaire (PAR-Q), or by physician clearance (Intervention study participants only)
  5. Low self-reported moderate-to-vigorous PA (<90 minutes/week)
  6. Able to enroll with one female non-spousal family member or friend (Intervention study participants only)
  7. Functioning mobile phone capable of accessing the internet and downloading mobile applications ("apps")

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Participation in the pre-intervention focus groups (Intervention study participants only)
  3. Participation in the last 90 days in a research study designed to promote physical activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199196


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Windsor Village United Methodist Church
Houston, Texas, United States, 77085
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Larkin L. Strong, PHD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03199196     History of Changes
Other Study ID Numbers: 2013-0717
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Cancer Prevention
African-American woman
Hispanic woman
Sedentary
Activity Tracker
Smartphone Application
Questionnaires
Surveys
Focus Group
Electronic Newsletters
Telephone Counseling