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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM115677 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity intervention | Experimental | All participants will receive a physical activity intervention consisting of goal setting, in-person physical activity sessions, and written materials. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Self-identify as female
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| Name | Affiliation | Role |
|---|---|---|
| Tayla von Ash, ScD, MPH | Brown University School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University School of Public Health | Providence | Rhode Island | 02903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity Intervention | All participants will receive a physical activity intervention consisting of goal setting, in-person physical activity sessions, and written materials. Physical activity intervention: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Activity Intervention | All participants will receive a physical activity intervention consisting of goal setting, in-person physical activity sessions, and written materials. Physical activity intervention: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Moderate to Vigorous Physical Activity (Minutes/Week) | Assessed using the 7-Day Physical Activity Recall Interview | Due to missing data, the number of participants analyzed is smaller than recruited. | Posted | Mean | Standard Deviation | minutes/week | Change from baseline to end of treatment (8 weeks) |
|
2 months
All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Activity Intervention | All participants will receive a physical activity intervention consisting of goal setting, in-person physical activity sessions, and written materials. Physical activity intervention: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tayla von Ash | Brown University | 401-863-6192 | tayla_ash@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2022 | Feb 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
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| D001519 | Behavior |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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