Expanded Population Health Model Evaluation

NCT ID: NCT06044831

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-28

Study Completion Date

2026-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Disease Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Expanded Population Health Access

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

Expanded Population Health Model

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Southern Star Medical Research Institute

UNKNOWN

Sponsor Role collaborator

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kevin Sykes

Director of Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin Sykes, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott & White Health and Wellness Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baylor Scott & White Health and Wellness Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Brittany Ajoku, MPH

Role: CONTACT

2148653076

Cristian Vargas, MPH

Role: CONTACT

2148653169

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Baylor IRB 023-136

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nutrition Education
NCT00005728 COMPLETED
Heart-health Promotion
NCT05949892 COMPLETED NA
Strong Hearts: Rural CVD Prevention
NCT02499731 COMPLETED NA
Stepping Into Lifestyle Changes
NCT05625321 ACTIVE_NOT_RECRUITING NA
FELLAShip to Better Health
NCT07220213 RECRUITING NA