Clinical trial NCT06337708: Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Official title: Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Physical Activity
Exercise
Heart Diseases
Diabetes Mellitus
Physical Inactivity
Keywords: mHealth
women's health
health equity
African American women
Black women
exercise
physical activity
heart disease
diabetes
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-03-29
Enrollment: 240
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.

Detailed description: This study addresses major public health concerns among African American women: physical inactivity and cardiometabolic disease risk.

African American women experience a high burden of cardiometabolic diseases, including heart disease, obesity, and type 2 diabetes. Regular aerobic physical activity is an established behavior to prevent and treat these conditions. Yet, the many African American women are insufficiently active, with only 27-40% meeting national aerobic physical activity guidelines.

This study will test the efficacy of Smart Walk, a culturally tailored, theory-based smartphone-delivered intervention designed to increase physical activity and improve cardiometabolic disease risk factors among African American women. In a 12-month trial, participants will be randomly assigned to either the Smart Walk intervention or a Fitbit-only comparison arm for an active 4-month intervention period, followed by an 8-month minimal contact follow-up period.

Specific Aims:

1. Test the effects of Smart Walk to increase physical activity and promote adherence to national aerobic physical activity guidelines; compared to Fitbit-only comparison group.
2. Test the effects of Smart Walk to improve cardiometabolic risk factors; compared to Fitbit-only comparison group.
3. Compare cost and cost effectiveness of the two intervention groups from a societal perspective.
4. Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes.

Eligibility criteria: Inclusion Criteria:

* Self-reported African American/Black female
* Aged of 24-65 years
* Insufficiently Active (\< 60 minutes of moderate-to-vigorous physical activity per week as measured by Exercise Vital Sign Questionnaire)
* BMI \> 30 kg/m2
* English speaking and reading
* Ownership of a smartphone with the ability to download applications (i.e., apps)
* Ownership of a smartphone with the ability to receive text messages
* Willingness to receive a physical activity intervention delivered through their smartphone
* Willingness to include their first name or create an alias to be used on their profile page on the Smart Walk app

Exclusion Criteria:

* Plans to relocate out of Phoenix area in next 12 months
* Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a doctor's note for study participation in provided
* Resting systolic blood pressure greater than 180 mmHG and/or a diastolic blood pressure greater than 120 mmHG , as assessed at baseline or at any other study assessment
* Self-reported participation in another diet or weight loss study at screening
* Pregnant or planning to become pregnant in the next 12 months

Primary outcomes:
measure: Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
Secondary outcomes:
measure: Change in cardiorespiratory fitness from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in aortic pulse wave velocity from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in body weight from baseline to 4- and 12-months.
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in body mass index from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in waste circumference from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in blood pressure (mmHG) from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in interleukin 6 (IL-6) from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in interleukin 10 (IL-10) from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in interleukin 15 (IL-15) from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in fasting blood glucose glucose from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in serum insulin from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in serum lipids (mg/DL) from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in exercise self-efficacy from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in self-regulation for physical activity from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in social support for physical activity from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in outcome expectations for physical activity from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
measure: Change in behavioral capability for physical activity from baseline to 4- and 12-months
timeFrame: Assessed at baseline, 4-months, 12-months
Other outcomes:
measure: Treatment acceptance
timeFrame: Assessed at 4-months and 12-months
measure: Protocol Adherence
timeFrame: Assessed at 4-months and 12-months
measure: Program costs
timeFrame: Assessed at 4-months and 12-months
measure: Participant costs
timeFrame: Assessed at 4-months and 12-months
measure: Cost-effectiveness
timeFrame: Assessed at 4-months and 12-month
measure: Objectively-measured home neighborhood characteristics
timeFrame: Assessed at baseline
measure: Subjectively-measured Neighborhood environment walkability
timeFrame: Assessed at baseline
measure: Race-related Stress
timeFrame: Assessed at baseline
measure: Perceived Structural Racism
timeFrame: Assessed at baseline
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: