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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02372565
Other study ID # STUDY00000485
Secondary ID
Status Completed
Phase N/A
First received February 6, 2015
Last updated February 25, 2015
Start date March 2014
Est. completion date June 2014

Study information

Verified date February 2015
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate 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. An 8-week, 2-arm randomized trial will be implemented. Arm 1 will receive a culturally-relevant, technology-based physical activity intervention delivered via Facebook and text messages. Arm 2 (Comparison Group) will receive a standard print-based physical activity promotion materials consisting of high quality physical activity promotion brochures produced by the American Heart Association.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 24 Years to 49 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Facebook and text Message
Culturally-relevant physical activity promotion program
Standard Print-based Intervention
Non-culturally relevant physical activity promotion program

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of Using Facebook and Text Messaging to Deliver a Physical Activity Program to African American Women 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) No
Secondary Change in physical activity from baseline to 8 weeks Assessed by ActiGraph GT3X+ accelerometers Two assessments, 8 weeks apart No
Secondary Change in exercise self-efficacy from baseline to 8 weeks Assessed by the Exercise Confidence Survey (Sallis, 1988) Two assessments, 8 weeks apart No
Secondary Change in social support for exercise from baseline to 8 weeks Assessed by the Social Support for Exercise Survey (Sallis,1987) Two assessments, 8 weeks apart No
Secondary Change in self-regulation for physical activity from baseline to 8 weeks Assessed by the Self-Regulation Scale from the Health Beliefs Survey (Anderson, 2010) Two assessments, 8 weeks apart No
Secondary Change in outcome expectations for exercise from baseline to 8 weeks Assessed by the Outcome Expectation Scale for Exercise (Resnick, 2000) Two assessments, 8 weeks apart No
Secondary Change in body mass index (BMI) from baseline to 8 weeks Two assessments, 8 weeks apart No
Secondary Change in total serum cholesterol from baseline to 8 weeks Two assessments, 8 weeks apart No
Secondary Change in serum high-density lipoprotein (HDL) cholesterol from baseline to 8 weeks Two assessments, 8 weeks apart No
Secondary Change in serum low-density lipoprotein (LDL) cholesterol from baseline to 8 weeks Two assessments, 8 weeks apart No
Secondary Change in serum triglycerides from baseline to 8 weeks Two assessments, 8 weeks apart No
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