NCT05461742

Brief Summary

The intervention aims to increase physical activity, an important health behavior, in a high-risk sample (i.e., Black and Hispanic/Latino mothers). The study builds on the investigators' previous work by adapting an evidence-based theory guided physical activity intervention to be implemented in a community setting mothers regularly spend time for their children's extracurricular activities, circumventing barriers commonly cited by racial/ethnic minority mothers (e.g., other responsibilities, time barriers, transportation, and childcare). The investigators will partner with a local youth sports organization to adapt and deliver a physical activity intervention to mothers during practice. They aim to convene a community advisory board of coaches and parents to enhance participant acceptability and work through any feasibility issues with implementation. The investigators will then conduct an open pilot trial of the physical activity intervention administered to mothers during their children's sports practices. They will assess feasibility, acceptability, and examine the effects of the intervention on mothers' physical activity. The investigators hypothesize that mothers in the intervention will increase their physical activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 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

First Submitted

Initial submission to the registry

July 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
20 days until next milestone

Results Posted

Study results publicly available

April 24, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

July 14, 2022

Results QC Date

March 1, 2024

Last Update Submit

April 23, 2024

Conditions

Keywords

physical activityexercisedisparitiesparentsmothers

Outcome Measures

Primary Outcomes (1)

  • Moderate to Vigorous Physical Activity (Minutes/Week)

    Assessed using the 7-Day Physical Activity Recall Interview

    Change from baseline to end of treatment (8 weeks)

Study Arms (1)

Physical activity intervention

EXPERIMENTAL

All participants will receive a physical activity intervention consisting of goal setting, in-person physical activity sessions, and written materials.

Behavioral: Physical activity intervention

Interventions

While the final content and structure of the intervention will be informed by community advisory board, participants will receive a culturally adapted, Social Cognitive Theory and Transtheoretical Model-based PA intervention. The evidence-based, theory guided aerobic physical activity intervention will systematically build upon the investigators' prior studies and includes the following components: goal setting, in-person physical activity sessions, and written materials.

Physical activity intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Identifying as female
  • Having (or being the primary caregiver of) a child who is a current member of one of the partner organization's teams/squads
  • Having email access
  • Being able to speak and read English or Spanish.

You may not qualify if:

  • For safety reasons, participants who do not pass the Physical Activity Readiness Questionnaire, a community screener used to detect those who may be at risk when increasing their physical activity, will be excluded from participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Tayla von Ash
Organization
Brown University

Study Officials

  • Tayla von Ash, ScD, MPH

    Brown University School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 18, 2022

Study Start

August 1, 2023

Primary Completion

December 1, 2023

Study Completion

April 4, 2024

Last Updated

April 24, 2024

Results First Posted

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations