Expanded Population Health Model Evaluation

Sponsor
Baylor Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT06044831
Collaborator
Southern Star Medical Research Institute (Other)
300
1
31.1
9.6

Study Details

Study Description

Brief Summary

This study will evaluate the impact of a comprehensive wellness and social determinants of health intervention on cardiovascular health in a community setting of the Bonton neighborhood. Participants will not be assigned to intervention activities, but health and wellbeing indicators will be collected in relation to how they choose to participate in activities over the year.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Expanded Population Health Model

Detailed Description

The specific aims of this study are to 1) evaluate whether a population health model integrated into a community setting improves cardiometabolic 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluating BSW HWC's Population Health Model Expansion at Bonton Farms: A Place-Based Quasi-Experimental Study Linking Medical and Social Services
Actual Study Start Date :
Aug 28, 2023
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Expanded Population Health Access

Participants living in the neighborhood with access to expanded population health model.

Behavioral: Expanded Population Health Model
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.

Outcome Measures

Primary Outcome Measures

  1. Cardiovascular Health Score [Baseline and 6 Months]

    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.

Secondary Outcome Measures

  1. Cardiovascular Health Score [12 Months]

    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.

  2. Metabolic Syndrome [Baseline, 6 Months, and 12 Months]

    Measured by the presence of three or more elevated factors from waist circumference, triglycerides, high density lipoprotein cholesterol, blood pressure, and A1C.

  3. Centers for Disease Control and Prevention Health Related Quality of Life Scale [Baseline, 6 Months, and 12 Months]

    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.

  4. Services utilization [Baseline, 6 Months, and 12 Months]

    Measured by self-report survey.

  5. Perceived Stress Scale [Baseline, 6 Months, and 12 Months]

    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.

  6. Center for Epidemiologic Studies Depression Scale 10 [Baseline, 6 Months, and 12 Months]

    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.

  7. Medical Outcomes Study Social Support Survey [Baseline, 6 Months, and 12 Months]

    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.

  8. Motivation and Attitudes Toward Changing Health [Baseline, 6 Months, and 12 Months]

    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.

  9. Brief Resilience Scale [Baseline, 6 Months, and 12 Months]

    Measured by self-report with Brief Resilience Scale with 6 items. Each item is scored 1-5. A higher sum score indicate higher resiliency.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age 18 years or older

  • Ability to alter diet and/or physical activity

  • Willing to participate in a 12-month study

  • Resident of Bonton neighborhood

  • 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 a resident of Bonton neighborhood

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baylor Scott & White Health and Wellness Center Dallas Texas United States 75210

Sponsors and Collaborators

  • Baylor Research Institute
  • Southern Star Medical Research Institute

Investigators

  • Principal Investigator: Leilani Dodgen, PhD, MPH, Baylor Scott & White Health and Wellness Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leilani Dodgen, PhD, Research Scientist, Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT06044831
Other Study ID Numbers:
  • Baylor IRB 023-136
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Leilani Dodgen, PhD, Research Scientist, Baylor Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023