Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05461742 |
Other study ID # |
2022003323 |
Secondary ID |
U54GM115677 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 1, 2023 |
Est. completion date |
April 4, 2024 |
Study information
Verified date |
April 2024 |
Source |
Brown University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
The intervention aims to increase physical activity, an important health behavior, in a
high-risk sample (i.e., Black and Hispanic/Latino mothers). As physical activity impacts risk
for obesity and related chronic diseases (Type II diabetes, heart disease, etc.), national
guidelines recommend that adults engage in 150 minutes of moderate intensity aerobic activity
per week. More than half of adults in Rhode Island do not meet this recommendation, and
racial and ethnic minorities are disproportionately burdened by obesity, and often exhibit
suboptimal physical activity-related behaviors. Racial/ethnic minority mothers may be at
particularly high risk for obesity, not just because of weight gain in the perinatal period,
but because the transition to parenthood, often accompanied by sleep disruption and decreased
physical activity, is a critical window for adult health and can shape health trajectories in
midlife. Further, mothers often report too many responsibilities and prioritizing their
children's needs as barriers to engaging in more physical activity. Racial/ethnic minority
mothers are especially likely to report lack of time as a barrier to being more physically
active. Interventions are therefore needed that address specific barriers among this
high-risk population. 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). They will partner with a
local youth sports organization to adapt and deliver a physical activity intervention to
mothers during practice.
The investigators aim to convene a community advisory board of coaches and parents to enhance
participant acceptability and work through any feasibility issues with implementation. The
community advisory board will include coaches and mothers from our partner organization, the
local youth football and cheerleading organization. The investigators will engage the
community advisory board to partner with us in adapting and refining the intervention. Prior
to the intervention, the community advisory board will inform the structure of the in-person
physical activity sessions. They will continue to meet with the community advisory board over
the study period to gain feedback around implementation and inform changes for a subsequent
grant a fully powered randomized controlled trial.
The second aim is to conduct an open pilot trial of the physical activity intervention
administered to mothers during their children's sports practices. The investigators aim to
recruit 45 mothers to participate in a single arm pre-test, post-test design pilot study of
the intervention, which will last for 8 weeks. They plan to demonstrate feasibility of
recruitment, retention, and data collection procedures, and acceptability of the intervention
using specified benchmarks. All participants will complete exit surveys at the end of the
intervention, with 15 participants invited to also complete an in depth interview. The
investigators will also examine within-person changes in minutes of moderate to vigorous
physical activity over time (e.g., from baseline to intervention end (8-weeks), and at
1-month follow up), as well as intervention dose effects (e.g., number of physical activity
sessions attended/week) on change in minutes of moderate to vigorous physical activity.