- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04073355
Smart Walk 50+: Feasibility of a Smartphone-delivered Physical Activity Program for African American Women 50 Years and Older
July 6, 2020 updated by: Rodney P Joseph, Arizona State University
The purpose of this study is to establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years.
To accomplish this, we will deliver our previously developed Smart Walk physical activity intervention, originally developed for African American women aged 24-50 years old, to 20 sedentary and obese African American women aged 50 to 65.
We will collect data on the acceptability and feasibility of the intervention, as well as areas of intervention refinement to enhance the social, cultural, and behavioral relevance of the intervention for women in this age group.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Arizona State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Self-reported African American female
- Between the ages of 50 to 65
- Insufficiently Active (less than or equal to 60 mins of moderate-to-vigorous physical activity/week measured by Exercise Vital Sign Questionnaire)
- BMI > 30
- English speaking and reading
Exclusion Criteria:
- Plans to relocate out of Phoenix area in next 6 months
- Endorsing an item on the PAR-Q, unless a doctor's note for study participation in provided
- Self-reported participation in another diet or weight loss study
- Non-English reading and speaking
- Pregnant or planning to become pregnant in the next 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical Activity
Smartphone-delivered physical activity intervention
|
Smartphone-delivered physical activity intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability and Feasibility: Treatment Acceptance
Time Frame: 4 months
|
Treatment acceptance will be assessed via a post-intervention treatment acceptance survey and qualitative data from a post-intervention focus group.
|
4 months
|
Acceptability and Feasibility: Number of participants who complete 4-month follow-up assessments
Time Frame: 4 months
|
Number of participants who complete 4-month follow-up assessment
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Objectively-measured Physical Activity
Time Frame: 4 months
|
Pre-post intervention changes in physical activity measured by accelerometers
|
4 months
|
Changes in self-reported Physical Activity
Time Frame: 4 months
|
Pre-post intervention changes in self-reported physical activity as measured by the REGICOR questionnaire
|
4 months
|
Changes in Exercise Self-efficacy
Time Frame: 4-months
|
Pre-post intervention changes in exercise self-efficacy.
Assessed by the Exercise Confidence Survey (Sallis, 1988).
|
4-months
|
Changes in Outcome Expectations for Exercise
Time Frame: 4-months
|
Pre-post intervention changes in outcome expectations for exercise; assessed by the Outcome Expectation Scale for Exercise (Resnick, 2000
|
4-months
|
Changes in Physical Activity Self-regulation
Time Frame: 4-months
|
Pre-post intervention changes in self-regulation for physical activity; assessed by the Self-Regulation Scale from the Health Beliefs Survey (Anderson, 2010)
|
4-months
|
Changes in Social Support for Exercise
Time Frame: 4-months
|
Pre-post intervention changes in social support for exercise; assessed by the Social Support for Exercise Survey (Sallis,1987)
|
4-months
|
Changes in Physical Activity Knowledge
Time Frame: 4-months
|
Pre-post intervention changes in knowledge of the national physical activity guidelines; assessed by a 6 item scale developed by study authors
|
4-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
August 26, 2019
First Submitted That Met QC Criteria
August 27, 2019
First Posted (Actual)
August 29, 2019
Study Record Updates
Last Update Posted (Actual)
July 8, 2020
Last Update Submitted That Met QC Criteria
July 6, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00010333
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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