Expanded Population Health Model Evaluation

NCT06044831 | Active Not Recruiting

• 1 other identifier: Baylor IRB 023-136
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease; Quality of Life

Keywords

Life Essential 8; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Cardiovascular Health Score

  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.

  Baseline and 6 Months

• Centers for Disease Control and Prevention Health Related Quality of Life Scale

  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.

  Baseline and 6 Months

Secondary Outcomes (9)

• Cardiovascular Health Score

  12 Months

• Metabolic Syndrome

  Baseline, 6 Months, and 12 Months

• Centers for Disease Control and Prevention Health Related Quality of Life Scale

  12 Months

• Services utilization

  Baseline, 6 Months, and 12 Months

• Perceived Stress Scale

  Baseline, 6 Months, and 12 Months

Study Arms (1)

Expanded Population Health Access

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

Behavioral: Expanded Population Health Model

Interventions

Expanded Population Health Model BEHAVIORAL

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.

Expanded Population Health Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead
• Southern Star Medical Research Institute: collaborator

Study Sites (1)

Baylor Scott & White Health and Wellness Center

Dallas, Texas, 75210, United States

Location

MeSH Terms

Conditions

Chronic Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Sykes, PhD, MPH

  Baylor Scott & White Health and Wellness Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 21, 2023
• Study Start: August 28, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)