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Completed

NCT Number: NCT02823379

Smart Walk: A Physical Activity Program for African American Women

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.

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Key information

Conditions

Physical Activity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

24 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rodney P. Joseph

Phoenix, Arizona, 85004, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

A Smartphone delivered physical activity program

Wellness

Behavioral

A Smartphone delivered wellness intervention focused on topics other than physical activity (e.g., skin care, oral health, and breast exams).

Primary outcomes

  1. Change in physical activity from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

    assessed by ActiGraph accelerometers

  2. Feasibility and acceptability of the Smartphone delivered physical activity program

    Time frame: 4-months

    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.

Secondary outcomes

  1. change in body mass index (BMI) from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

  2. change in cardiorespiratory fitness from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

    A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2peak).

  3. change in Aortic Pulse Wave Velocity from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

    A measure of aortic stiffness, will be assessed with SphymocorTM using validated methodology

  4. change in blood pressure from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

  5. change in total serum cholesterol from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

  6. change in serum high-density lipoprotein (HDL) from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

  7. change in serum low-density lipoprotein (LDL) from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

  8. change in serum triglycerides from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

  9. change in serum insulin from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

    measured using Immulite 1000 immunoassay analyzer (Siemens Healthcare Diagnostics)

  10. change in insulin sensitivity from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

    assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405.

  11. change in tumor necrosis factor alpha from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

  12. change in Interleukin 1 beta from baseline to 8-months

    Time frame: three assessment periods: baseline, 4-months, and 8-months

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 6, 2016
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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