## Protocol Section
### Identification Module
**NCT ID:** NCT02823379

**Brief Title:** Smart Walk: A Physical Activity Program for African American Women

**Official Title:** Smart Walk: A Physical Activity Program for African American Women

#### Organization Study ID Info
**ID:** STUDY00003131
#### Organization
**Class:** OTHER
**Full Name:** Arizona State University
#### Secondary ID Infos
**ID:** K99HL129012
**Link:** https://reporter.nih.gov/quickSearch/K99HL129012
**Type:** NIH
**ID:** R00HL129012
**Link:** https://reporter.nih.gov/quickSearch/R00HL129012
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2020-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-07-08

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-06

**Type:** ACTUAL

#### Start Date
**Date:** 2015-09

**Status Verified Date:** 2020-07

#### Study First Post Date
**Date:** 2016-07-06
**Type:** ESTIMATED
**Study First Submit Date:** 2016-07-01
**Study First Submit QC Date:** 2016-07-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Heart, Lung, and Blood Institute (NHLBI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Arizona State University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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

### Conditions Module

**Conditions:**

- Physical Activity

**Keywords:**

- physical activity

- overweight

- obese

- exercise

- women

- African American

- Smartphone

- cardiovascular disease risk

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 62

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A culturally relevant physical activity promotion program delivered using a Smartphone application.

**Intervention Names:**

- Behavioral: Physical Activity

**Label:** Physical Activity

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A wellness contract control condition delivered using a Smartphone application.

**Intervention Names:**

- Behavioral: Wellness

**Label:** Wellness Contact Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Physical Activity

**Description:** A Smartphone delivered physical activity program

**Name:** Physical Activity

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Wellness Contact Control

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

**Name:** Wellness

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** assessed by ActiGraph accelerometers

**Measure:** Change in physical activity from baseline to 8-months

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

**Description:** 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.

**Measure:** Feasibility and acceptability of the Smartphone delivered physical activity program

**Time Frame:** 4-months

#### Secondary Outcomes

**Measure:** change in body mass index (BMI) from baseline to 8-months

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

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

**Measure:** change in cardiorespiratory fitness from baseline to 8-months

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

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

**Measure:** change in Aortic Pulse Wave Velocity from baseline to 8-months

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

**Measure:** change in blood pressure from baseline to 8-months

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

**Measure:** change in total serum cholesterol from baseline to 8-months

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

**Measure:** change in serum high-density lipoprotein (HDL) from baseline to 8-months

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

**Measure:** change in serum low-density lipoprotein (LDL) from baseline to 8-months

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

**Measure:** change in serum triglycerides from baseline to 8-months

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

**Description:** measured using Immulite 1000 immunoassay analyzer (Siemens Healthcare Diagnostics)

**Measure:** change in serum insulin from baseline to 8-months

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

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

**Measure:** change in insulin sensitivity from baseline to 8-months

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

**Measure:** change in tumor necrosis factor alpha from baseline to 8-months

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

**Measure:** change in Interleukin 1 beta from baseline to 8-months

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

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 49 Years

**Minimum Age:** 24 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** Rodney P. Joseph

**State:** Arizona

**Zip:** 85004

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** 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.

**PMID:** 35794781

**Citation:** 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.

**PMID:** 29058603

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
