NCT02823379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

4.8 years

First QC Date

July 1, 2016

Last Update Submit

July 6, 2020

Conditions

Physical Activity

Keywords

physical activityoverweightobeseexercisewomenAfrican AmericanSmartphonecardiovascular disease risk

Outcome Measures

Primary Outcomes (2)

  • Change in physical activity from baseline to 8-months

    assessed by ActiGraph accelerometers

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

  • 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 Outcomes (12)

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

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

  • change in cardiorespiratory fitness from baseline to 8-months

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

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

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

  • change in blood pressure from baseline to 8-months

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

  • change in total serum cholesterol from baseline to 8-months

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

  • +7 more secondary outcomes

Study Arms (2)

Physical Activity

EXPERIMENTAL

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

Behavioral: Physical Activity

Wellness Contact Control

ACTIVE COMPARATOR

A wellness contract control condition delivered using a Smartphone application.

Behavioral: Wellness

Interventions

Physical ActivityBEHAVIORAL

A Smartphone delivered physical activity program

Physical Activity
WellnessBEHAVIORAL

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

Wellness Contact Control

Eligibility Criteria

Age24 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodney P. Joseph

Phoenix, Arizona, 85004, United States

Location

Related Publications (3)

  • 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.

    PMID: 38375882DERIVED

  • 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: 35794781DERIVED

  • 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: 29058603DERIVED

MeSH Terms

Conditions

Motor ActivityOverweightObesity

Interventions

ExerciseHealth

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 6, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations

US(1)