- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02372565
Facebook to Promote Physical Activity in Black Women African American Women
Using Mass Media to Promote Physical Activity in African American Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to apply and investigate the feasibility of a social media and text-message-delivered, Social Cognitive Theory-based, culturally relevant intervention designed to promote physical activity among African American women. In an 8-week, 2-arm randomized trial, 30 African American women will be assigned to receive either: a) culturally-relevant, technology-based physical activity intervention delivered via Facebook and text messages, or b) a standard print-based physical activity promotion intervention consisting of high quality physical activity promotion brochures produced by the American Heart Association delivered via USPS mail.
Aim 1: Test the feasibility of a culturally relevant, social media and text-message delivered physical promotion pilot intervention among adult African American women. The investigators hypothesize that the culturally relevant Facebook and text message delivered intervention will be feasible as measured by the acceptability, implementation, and practicality of the intervention program.
Aim 2: Examine the impact of the culturally-relevant, Facebook and text message delivered intervention to increase physical activity and enhance associated Social Cognitive Theory constructs explicitly targeted by the intervention activities. Physical activity will be objectively measured by accelerometers and Social Cognitive Theory constructs of self-efficacy, social support, self-regulation, and outcome expectations will be assessed by validated self-report questionnaires. The investigators hypothesize that participants receiving the culturally-adapted, Social Cognitive Theory-based Facebook and text-message intervention will demonstrate higher physical activity levels and greater enhancements in Social Cognitive Theory constructs when compared to the standard print-based intervention group at the post-intervention assessment.
Aim 3: Examine the preliminary effect of a culturally relevant, social media-delivered physical activity promotion intervention on anthropometric, blood pressure, and blood lipid outcomes. The investigators hypothesize that increased physical activity at the post-intervention follow-up will be associated with improvements in these variables.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- self-identified as African American
- female
- insufficiently active (<150 min/week of moderate-intensity physical activity assessed by the short version of the International Physical Activity Questionnaire)
- aged 24-49 years
- having an active Facebook account
- ability to read/write in English
Exclusion Criteria:
- concurrent participation in another physical activity promotion program (research or commercial)
- being pregnant or planning on becoming pregnant in the next 6 months, and
- self-reported condition that inhibits engagement in physical activity
- contraindication for physical activity according to the Physical Activity Readiness Questionnaire (PAR-Q) unless written permission from the participant's physician to engage in the study is provided
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Facebook and Text Message
Participants randomized to the technology-based physical activity intervention will receive a culturally-relevant physical activity promotion intervention delivered via text messages and the social media website Facebook.
The purpose of the intervention materials is to encourage participants to achieve a minimum of 150 minutes/week of moderate-intensity aerobic physical activity each week.
|
Culturally-relevant physical activity promotion program
|
|
Active Comparator: Standard Print-based Intervention
Participants randomized to the standard print-based physical activity intervention group will be mailed 4 self-help booklets promoting physical activity produced by the American Heart Association.
Booklets will be mailed one at a time in 2 week intervals over the 1st 6-weeks of the intervention.
These high quality booklets provide general information on the benefits of physical activity, tips and strategies to increase daily physical activity, and encourage recipients to perform a minimum of 10,000 steps per day.
|
Non-culturally relevant physical activity promotion program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Using Facebook and Text Messaging to Deliver a Physical Activity Program to African American Women
Time Frame: Post Intervention (up to 8 weeks)
|
Measured using a composite score by assessing acceptability (participants perceived satisfaction and usefulness of the program; perceived cultural relevance of the program), demand (interest in study participation; participant retention), and implementation (participant activity on the Facebook group page, successful delivery of text messages, successful delivery of study materials on the study Facebook wall) of the culturally relevant physical activity program.
|
Post Intervention (up to 8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Assessed by ActiGraph GT3X+ accelerometers
|
Two assessments, 8 weeks apart
|
|
Change in exercise self-efficacy from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Assessed by the Exercise Confidence Survey (Sallis, 1988)
|
Two assessments, 8 weeks apart
|
|
Change in social support for exercise from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Assessed by the Social Support for Exercise Survey (Sallis,1987)
|
Two assessments, 8 weeks apart
|
|
Change in self-regulation for physical activity from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Assessed by the Self-Regulation Scale from the Health Beliefs Survey (Anderson, 2010)
|
Two assessments, 8 weeks apart
|
|
Change in outcome expectations for exercise from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Assessed by the Outcome Expectation Scale for Exercise (Resnick, 2000)
|
Two assessments, 8 weeks apart
|
|
Change in body mass index (BMI) from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Two assessments, 8 weeks apart
|
|
|
Change in total serum cholesterol from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Two assessments, 8 weeks apart
|
|
|
Change in serum high-density lipoprotein (HDL) cholesterol from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Two assessments, 8 weeks apart
|
|
|
Change in serum low-density lipoprotein (LDL) cholesterol from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Two assessments, 8 weeks apart
|
|
|
Change in serum triglycerides from baseline to 8 weeks
Time Frame: Two assessments, 8 weeks apart
|
Two assessments, 8 weeks apart
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000485
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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