NCT03199196

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
May 2014May 2026

Study Start

First participant enrolled

May 2, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

12.1 years

First QC Date

June 22, 2017

Last Update Submit

April 14, 2023

Conditions

Keywords

Cancer PreventionAfrican-American womanHispanic womanSedentaryActivity TrackerSmartphone ApplicationQuestionnairesSurveysFocus GroupElectronic NewslettersTelephone Counseling

Outcome Measures

Primary Outcomes (1)

  • Women's Preferences for a Physical Activity (PA) Promotion Intervention

    Women's preferences for a physical activity (PA) promotion intervention determined by focus groups.

    16 weeks

Secondary Outcomes (1)

  • Feasibility of a Social Network-Based Physical Activity (PA) Intervention in Sedentary Women Who are Primarily African American (AA) and Hispanic

    16 weeks

Study Arms (2)

Group 1 - Intervention

EXPERIMENTAL

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 TrackerDevice: Smartphone ApplicationBehavioral: QuestionnairesBehavioral: Focus GroupBehavioral: Electronic NewslettersBehavioral: Telephone Counseling

Group 2 - Control

OTHER

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: QuestionnairesBehavioral: Focus GroupBehavioral: Electronic Newsletters

Interventions

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.

Group 1 - Intervention

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.

Group 1 - Intervention
QuestionnairesBEHAVIORAL

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.

Also known as: Surveys
Group 1 - InterventionGroup 2 - Control
Focus GroupBEHAVIORAL

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.

Group 1 - InterventionGroup 2 - Control

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

Group 1 - InterventionGroup 2 - Control

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 1 - Intervention

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self-reported AA race or Hispanic ethnicity (all participants except partners)
  • Age 25-60 years
  • 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)
  • 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)
  • Low self-reported moderate-to-vigorous PA (\<90 minutes/week)
  • Able to enroll with one female non-spousal family member or friend (Intervention study participants only)
  • Functioning mobile phone capable of accessing the internet and downloading mobile applications ("apps")

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Windsor Village United Methodist Church

Houston, Texas, 77085, United States

Location

Related Links

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Fitness TrackersSurveys and QuestionnairesFocus Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and SuppliesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Larkin L. Strong, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 26, 2017

Study Start

May 2, 2014

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations