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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Physical Inactivity
- 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 group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | All 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.
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.
- First posted18 Jul 2022
- Study start1 Aug 2023
- Primary completion1 Dec 2023
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Tayla von Ash, ScD, MPH, Principal investigator, Brown University School of Public Health
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing an Innovative Physical Activity Intervention for Parents
- ClinicalTrials.gov ID
- NCT05461742
- Acronym / sponsor ID
- 2022003323
- Conditions
- Physical Inactivity
- Keywords
- physical activity, exercise, disparities, parents, mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Posted 24 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionAll participants will receive a physical activity intervention consisting of goal setting, in-person physical activity sessions, and written materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionWhile 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. | Behavioural | Physical activity intervention |
Primary outcome
Moderate to Vigorous Physical Activity (Minutes/Week)
Time frame: Change from baseline to end of treatment (8 weeks)
Assessed using the 7-Day Physical Activity Recall Interview
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tayla von Ash, ScD, MPH principal investigator
Brown University School of Public Health
1 site in 1 country: see every site and its status.
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.