AzTrials
AzTrials

Physical ActivityNCT02823379

Smart Walk: A Physical Activity Program for African American Women

A study testing Physical Activity and Wellness in people with Physical Activity, run by Arizona State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 24 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Physical Activity and Wellness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
Sep 2015to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rodney P. Joseph

    Phoenix, Arizona, 85004

Other trials in United States

About this study

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.

Read the detailed 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

Being tested
Physical Activity, Wellness
Keywords
physical activity, overweight, obese, exercise, women, African American, Smartphone, cardiovascular disease risk
Medical subject headings
Motor Activity, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ActivityBehavioural

    A Smartphone delivered physical activity program

  • WellnessBehavioural

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

Study groups in NCT02823379
Study groupRoleWhat they receive
Physical ActivityExperimentalA culturally relevant physical activity promotion program delivered using a Smartphone application.
Receives: Behavioral: Physical Activity
Wellness Contact ControlActive comparatorA wellness contract control condition delivered using a Smartphone application.
Receives: Behavioral: Wellness

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    assessed by ActiGraph accelerometers

    Measured: three assessment periods: baseline, 4-months, and 8-months

  2. 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.

    Measured: 4-months

Secondary outcomes (12)

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

    measured using Immulite 1000 immunoassay analyzer (Siemens Healthcare Diagnostics)

    Measured: three assessment periods: baseline, 4-months, and 8-months

  10. 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.

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

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

    Measured: three assessment periods: baseline, 4-months, and 8-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionJun 2020
  4. Study completionJun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823379
Sponsor's protocol ID
STUDY00003131
Other IDs
K99HL129012, R00HL129012
Status last verified
Jul 2020
First submitted
1 Jul 2016
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PubMed 38375882

  • Joseph RP, Ainsworth BE, Vega-Lopez S, Adams MA, Todd M, Gaesser GA, Keller C. Cardiometabolic Risk Factors Among Insufficiently Active African American Women With Obesity: Baseline Findings From Smart Walk. J Cardiovasc Nurs. 2023 Mar-Apr 01;38(2):198-204. doi: 10.1097/JCN.0000000000000930. Epub 2022 Jul 5.

    PubMed 35794781

  • Joseph RP, Ainsworth BE, Mathis L, Hooker SP, Keller C. Incorporating religion and spirituality into the design of community-based physical activity programs for African American women: a qualitative inquiry. BMC Res Notes. 2017 Oct 23;10(1):506. doi: 10.1186/s13104-017-2830-3.

    PubMed 29058603

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity and Wellness in people with Physical Activity, run by Arizona State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical activity from baseline to 8-months (time frame: three assessment periods: baseline, 4-months, and 8-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823379, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in