NCT04073355

Brief Summary

The purpose of this study is to establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

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

August 10, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

August 26, 2019

Last Update Submit

July 6, 2020

Conditions

Keywords

exerciseAfrican American womenmHealtheHealthsmartphone

Outcome Measures

Primary Outcomes (2)

  • Acceptability and Feasibility: Treatment Acceptance

    Treatment acceptance will be assessed via a post-intervention treatment acceptance survey and qualitative data from a post-intervention focus group.

    4 months

  • Acceptability and Feasibility: Number of participants who complete 4-month follow-up assessments

    Number of participants who complete 4-month follow-up assessment

    4 months

Secondary Outcomes (7)

  • Changes in Objectively-measured Physical Activity

    4 months

  • Changes in self-reported Physical Activity

    4 months

  • Changes in Exercise Self-efficacy

    4-months

  • Changes in Outcome Expectations for Exercise

    4-months

  • Changes in Physical Activity Self-regulation

    4-months

  • +2 more secondary outcomes

Study Arms (1)

Physical Activity

EXPERIMENTAL

Smartphone-delivered physical activity intervention

Behavioral: Physical Activity

Interventions

Smartphone-delivered physical activity intervention

Physical Activity

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported African American female
  • Between the ages of 50 to 65
  • Insufficiently Active (less than or equal to 60 mins of moderate-to-vigorous physical activity/week measured by Exercise Vital Sign Questionnaire)
  • BMI \> 30
  • English speaking and reading

You may not qualify if:

  • Plans to relocate out of Phoenix area in next 6 months
  • Endorsing an item on the PAR-Q, unless a doctor's note for study participation in provided
  • Self-reported participation in another diet or weight loss study
  • Non-English reading and speaking
  • Pregnant or planning to become pregnant in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

  • Joseph RP, Ainsworth BE, Hollingshead K, Todd M, Keller C. Results of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention Among Midlife African American Women: Feasibility Trial. JMIR Mhealth Uhealth. 2021 Apr 22;9(4):e27383. doi: 10.2196/27383.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 29, 2019

Study Start

August 10, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations