Smart Walk: A Physical Activity Program for African American Women

Physical Activity Clinical Trial

Official title:

Smart Walk: A Physical Activity Program for African American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823379
• Other study ID #: STUDY00003131
• Secondary ID: K99HL129012R00HL
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 2020

Study information

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

Clinical Trial Summary

The purpose of this project is to test an 8-month, culturally relevant, Smartphone-delivered PA program to improve and maintain high physical levels and reduce cardiometabolic disease risk among obese AA women.

Description:

A three-phase study will be used to refine and implement an established theory-based culturally relevant physical activity promotion intervention for obese African American women. Phase 1 (Aim 1a) will include formative research where 25 African American women provide feedback (via 9 focus groups) to further refine the physical activity intervention by specifying the deep structure cultural relevance of the theoretical mediators of self-regulation, self-efficacy, social support, behavioral capability, and outcome expectations.5 Phase 2 will focus on technical development of the refined culturally tailored intervention and 1-month demonstration trial of the Smartphone-delivered physical activity promotion program. Phase 3 (Aims 1b and 1c) will test the intervention and delivery strategy in a two-arm randomized trial where 60 sedentary, obese African American women will receive either the 8-month culturally relevant smartphone-delivered physical activity intervention or a 8-month wellness contact control condition

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 49 Years

Eligibility

Inclusion Criteria:

• Self-reported African American

• Insufficiently Active ( 60 mins or less of PA per wk measured by Exercise Vital Sign Questionnaire)

• BMI>30

• English speaking and reading

• Own non-Kindle Smartphone iOS 7 or above, or Android 2.3 or above

Exclusion Criteria:

• Concurrent participation in another physical activity, nutrition, or weight loss program

• Endorsement of an item on the Physical Activity Readiness Questionnaire (PAR-Q) unless physical note is provided

• Pregnant or plans to become pregnant in next 12 months

• Plans to relocate out of Phoenix area in next 12 months

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Physical Activity
A Smartphone delivered physical activity program
• Wellness
A Smartphone delivered wellness intervention focused on topics other than physical activity (e.g., skin care, oral health, and breast exams).

Locations

Country	Name	City	State
United States	Rodney P. Joseph	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity from baseline to 8-months	assessed by ActiGraph accelerometers	three assessment periods: baseline, 4-months, and 8-months
Primary	Feasibility and acceptability of the Smartphone delivered physical activity program	Feasibility and acceptability will be assessed by examining recruitment, retention, adherence, self-reported treatment acceptance, and participant utilization of the Smartphone application provided by analytic tracking software.	4-months
Secondary	change in body mass index (BMI) from baseline to 8-months		three assessment periods: baseline, 4-months, and 8-months
Secondary	change in cardiorespiratory fitness from baseline to 8-months	A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2peak).	three assessment periods: baseline, 4-months, and 8-months
Secondary	change in Aortic Pulse Wave Velocity from baseline to 8-months	A measure of aortic stiffness, will be assessed with SphymocorTM using validated methodology	three assessment periods: baseline, 4-months, and 8-months
Secondary	change in blood pressure from baseline to 8-months		three assessment periods: baseline, 4-months, and 8-months
Secondary	change in total serum cholesterol from baseline to 8-months		three assessment periods: baseline, 4-months, and 8-months
Secondary	change in serum high-density lipoprotein (HDL) from baseline to 8-months		three assessment periods: baseline, 4-months, and 8-months
Secondary	change in serum low-density lipoprotein (LDL) from baseline to 8-months		three assessment periods: baseline, 4-months, and 8-months
Secondary	change in serum triglycerides from baseline to 8-months		three assessment periods: baseline, 4-months, and 8-months
Secondary	change in serum insulin from baseline to 8-months	measured using Immulite 1000 immunoassay analyzer (Siemens Healthcare Diagnostics)	three assessment periods: baseline, 4-months, and 8-months
Secondary	change in insulin sensitivity from baseline to 8-months	assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (µU/ml)/405.	three assessment periods: baseline, 4-months, and 8-months
Secondary	change in tumor necrosis factor alpha from baseline to 8-months		three assessment periods: baseline, 4-months, and 8-months
Secondary	change in Interleukin 1 beta from baseline to 8-months		three assessment periods: baseline, 4-months, and 8-months