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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04073355
Other study ID # STUDY00010333
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 10, 2019
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity
Smartphone-delivered physical activity intervention

Locations

Country Name City State
United States Arizona State University Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability and Feasibility: Treatment Acceptance Treatment acceptance will be assessed via a post-intervention treatment acceptance survey and qualitative data from a post-intervention focus group. 4 months
Primary Acceptability and Feasibility: Number of participants who complete 4-month follow-up assessments Number of participants who complete 4-month follow-up assessment 4 months
Secondary Changes in Objectively-measured Physical Activity Pre-post intervention changes in physical activity measured by accelerometers 4 months
Secondary Changes in self-reported Physical Activity Pre-post intervention changes in self-reported physical activity as measured by the REGICOR questionnaire 4 months
Secondary Changes in Exercise Self-efficacy Pre-post intervention changes in exercise self-efficacy. Assessed by the Exercise Confidence Survey (Sallis, 1988). 4-months
Secondary Changes in Outcome Expectations for Exercise Pre-post intervention changes in outcome expectations for exercise; assessed by the Outcome Expectation Scale for Exercise (Resnick, 2000 4-months
Secondary Changes in Physical Activity Self-regulation 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
Secondary Changes in Social Support for Exercise Pre-post intervention changes in social support for exercise; assessed by the Social Support for Exercise Survey (Sallis,1987) 4-months
Secondary Changes in Physical Activity Knowledge Pre-post intervention changes in knowledge of the national physical activity guidelines; assessed by a 6 item scale developed by study authors 4-months
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