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Physical InactivityNCT05461742

Pilot Testing an Innovative Physical Activity Intervention for Parents Attending Their Children's Sport Practices

A study testing Physical activity intervention in people with Physical Inactivity, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Physical Inactivity
What is being tested?
Physical activity intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 4 Apr 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brown University School of Public Health

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: Pilot Testing an Innovative Physical Activity Intervention for Parents

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.

Read the detailed 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.

Being tested
Physical activity intervention
Keywords
physical activity, exercise, disparities, parents, mothers
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity interventionBehavioural

    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.

Study groups in NCT05461742
Study groupRoleWhat they receive
Physical activity interventionExperimentalAll participants will receive a physical activity intervention consisting of goal setting, in-person physical activity sessions, and written materials.
Receives: Behavioral: Physical activity intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Moderate to Vigorous Physical Activity (Minutes/Week)

    Assessed using the 7-Day Physical Activity Recall Interview

    Measured: Change from baseline to end of treatment (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start1 Aug 2023
  3. Primary completion1 Dec 2023
  4. Study completion4 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05461742
Sponsor's protocol ID
2022003323
Other IDs
U54GM115677
Status last verified
Apr 2024
First submitted
14 Jul 2022
Last updated
24 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity intervention in people with Physical Inactivity, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Moderate to Vigorous Physical Activity (Minutes/Week) (time frame: Change from baseline to end of treatment (8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.

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