- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06044831
Expanded Population Health Model Evaluation
Evaluating BSW HWC's Population Health Model Expansion at Bonton Farms: A Place-Based Quasi-Experimental Study Linking Medical and Social Services
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific aims of this study are to 1) evaluate whether a population health model integrated into a community setting improves cardiovascular health and quality of life in adults 18 years or older and 2) evaluate which programs and services provide the most impact for specific sub-groups of individuals, e.g., elderly, individuals with diabetes, etc.
Participants will receive programs from the existing population health model from Baylor Scott & White Health and Wellness Center with additional programs from a local community organization. Individuals will complete study measures at baseline, 6 months, and 12 months.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75210
- Baylor Scott & White Health and Wellness Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- Ability to alter diet and/or physical activity
- Willing to participate in a 12-month study
- Willing and able to participate in programs at Bonton Farms
- Cannot have participated in an intensive lifestyle change program (Group Lifestyle Balance, Health Eating and Lifestyle Program, or first cohort of apprenticeship) in the last 6 months or have attended more than two weeks of an intensive lifestyle change program
- Cannot be diagnosed with a terminal illness
- Cannot be pregnant or planning to get pregnant in the next 12 months
Exclusion Criteria:
- Below the age of 18 years
- Unable to alter diet and physical activity due to medical condition
- Not willing to participate in a 12-month study
- Not willing and unable to participate in programs at Bonton Farms
- Participated in an intensive lifestyle change program (Group Lifestyle Balance, Health Eating and Lifestyle Program, or first cohort of Bonton Farms' apprenticeship) or has attended more than two weeks of an intensive lifestyle change
- Be diagnosed with a terminal illness
- Currently pregnant or planning to get pregnant in the next 12 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Expanded Population Health Access
Participants living in the neighborhood with access to expanded population health model.
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This intervention includes the current population health model in addition to expanded programming from a local community organization.
The current population health model with Baylor Scott & White Health and Wellness Center includes access to primary care, general wellness programs such as cooking classes and nutritional counseling, and evidence-based disease management and prevention.
The additional programs from a local community organization focus on human essentials integral to improving health and quality of life and include: health and wellness, economic stability, safe and affordable housing, transportation, a sense of belonging, education, and access to fair credit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cardiovascular Health Score
Time Frame: Baseline and 6 Months
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Life's Essential 8 composite score includes 8 metrics used to measure cardiovascular health.
The metrics are diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure.
Each individual metric is scored 0-100 based on clinical thresholds and the composite score is the unweighted, aggregate of all the metrics.
Scores 0-49 are considered low cardiovascular health, 50-79 moderate cardiovascular health, and 80-100 high cardiovascular health.
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Baseline and 6 Months
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Centers for Disease Control and Prevention Health Related Quality of Life Scale
Time Frame: Baseline and 6 Months
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Measured by self report with Centers for Disease Control and Prevention Health Related Quality of Life Scale.
Two modules (Healthy Days and Healthy Days Symptoms) are assessed in 9 items.
Only the items in the Healthy Days Module produces a score and it is the sum of healthy and unhealthy days.
A higher sum is associated with mental distress or activity limitation.
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Baseline and 6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cardiovascular Health Score
Time Frame: 12 Months
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Life's Essential 8 composite score includes 8 metrics used to measure cardiovascular health.
The metrics are diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure.
Each individual metric is scored 0-100 based on clinical thresholds and the composite score is the unweighted, aggregate of all the metrics.
Scores 0-49 are considered low cardiovascular health, 50-79 moderate cardiovascular health, and 80-100 high cardiovascular health.
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12 Months
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Metabolic Syndrome
Time Frame: Baseline, 6 Months, and 12 Months
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Measured by the presence of three or more elevated factors from waist circumference, triglycerides, high density lipoprotein cholesterol, blood pressure, and A1C.
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Baseline, 6 Months, and 12 Months
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Services utilization
Time Frame: Baseline, 6 Months, and 12 Months
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Measured by self-report survey.
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Baseline, 6 Months, and 12 Months
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Perceived Stress Scale
Time Frame: Baseline, 6 Months, and 12 Months
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Measured by self-report with Perceived Stress Scale with 10 items.
Each item is scored 0-4.
A higher sum score indicates higher perceived stress.
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Baseline, 6 Months, and 12 Months
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Center for Epidemiologic Studies Depression Scale 10
Time Frame: Baseline, 6 Months, and 12 Months
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Measured by self-report with Center for Epidemiologic Studies Depression Scale 10 with 10 items.
Each item is scored 0-4.
A sum of 10 or higher indicates depressive symptoms.
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Baseline, 6 Months, and 12 Months
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Medical Outcomes Study Social Support Survey
Time Frame: Baseline, 6 Months, and 12 Months
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Measured by self-report with Medical Outcomes Study Social Support Survey.
This instrument includes 4 subscales (Emotional/informational Support, Tangible Support, Affectionate Support, Positive Social Interaction) with 18 items.
Each item is scored 1-5.
A higher subscale average indicates greater social support.
Additionally, an overall support index can also be calculated by taking the average of the 18 items included in subscales and the score for Question 13.
A higher score on the overall support index indicates greater social support.
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Baseline, 6 Months, and 12 Months
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Motivation and Attitudes Toward Changing Health
Time Frame: Baseline, 6 Months, and 12 Months
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Measured by self-report with Motivation and Attitudes Toward Changing Health.
This instrument includes 3 subscales (Willingness, Worthwhile, and Ability) with a total of 9 items.
Each item is scored 1-5.
A higher subscale average indicates one or more of the following: 1) greater willingness to do things to manage health, 2) more likely to view benefits of change as worthwhile, and/or 3) feeling more capable of making and sustaining change.
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Baseline, 6 Months, and 12 Months
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Brief Resilience Scale
Time Frame: Baseline, 6 Months, and 12 Months
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Measured by self-report with Brief Resilience Scale with 6 items.
Each item is scored 1-5.
A higher sum score indicate higher resiliency.
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Baseline, 6 Months, and 12 Months
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Centers for Disease Control and Prevention Health Related Quality of Life Scale
Time Frame: 12 Months
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Measured by self report with Centers for Disease Control and Prevention Health Related Quality of Life Scale.
Two modules (Healthy Days and Healthy Days Symptoms) are assessed in 9 items.
Only the items in the Healthy Days Module produces a score and it is the sum of healthy and unhealthy days.
A higher sum is associated with mental distress or activity limitation.
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12 Months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin Sykes, PhD, MPH, Baylor Scott & White Health and Wellness Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Baylor IRB 023-136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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