Chronic DiseaseNCT06044831
Expanded Population Health Model Evaluation
An observational study of Chronic Disease and Quality of Life, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Quality of Life
- What is being tested?
- Expanded Population Health Model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 28 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants living in the neighborhood with access to expanded population health model.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Health and Wellness Center
Dallas, Texas, 75210
About this study
Official title: Evaluating BSW HWC's Population Health Model Expansion at Bonton Farms: A Place-Based Quasi-Experimental Study Linking Medical and Social Services
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.
Read the 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.
- Conditions
- Chronic Disease, Quality of Life
- Being tested
- Expanded Population Health Model
- Keywords
- Life Essential 8, Cardiovascular Disease
- Medical subject headings
- Chronic Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Population Health ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Expanded Population Health Access | Participants living in the neighborhood with access to expanded population health model. Receives: Behavioral: Expanded Population Health Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 Months
Secondary outcomes (9)
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.
Measured: 12 Months
Metabolic Syndrome
Measured by the presence of three or more elevated factors from waist circumference, triglycerides, high density lipoprotein cholesterol, blood pressure, and A1C.
Measured: Baseline, 6 Months, and 12 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.
Measured: 12 Months
Services utilization
Measured by self-report survey.
Measured: Baseline, 6 Months, and 12 Months
Perceived Stress Scale
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.
Measured: Baseline, 6 Months, and 12 Months
Center for Epidemiologic Studies Depression Scale 10
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.
Measured: Baseline, 6 Months, and 12 Months
Medical Outcomes Study Social Support Survey
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.
Measured: Baseline, 6 Months, and 12 Months
Motivation and Attitudes Toward Changing Health
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.
Measured: Baseline, 6 Months, and 12 Months
Brief Resilience Scale
Measured by self-report with Brief Resilience Scale with 6 items. Each item is scored 1-5. A higher sum score indicate higher resiliency.
Measured: Baseline, 6 Months, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start28 Aug 2023
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Star Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Kevin Sykes, PhD, MPH, Principal investigator, Baylor Scott & White Health and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044831
- Sponsor's protocol ID
- Baylor IRB 023-136
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating BSW HWC's Population Health Model Expansion at Bonton Farms: A Place-Based Quasi-Experimental Study Linking Medical and Social Services
- ClinicalTrials.gov ID
- NCT06044831
- Acronym / sponsor ID
- Baylor IRB 023-136
- Conditions
- Chronic Disease, Quality of Life
- Keywords
- Life Essential 8, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Southern Star Medical Research Institute
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expanded Population Health Access | – | Behavioral: Expanded Population Health ModelParticipants living in the neighborhood with access to expanded population health model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants living in the neighborhood with access to expanded population health model.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded Population Health ModelThis 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. | Behavioural | Expanded Population Health Access |
Primary outcome
Cardiovascular Health Score
Time frame: 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.
Centers for Disease Control and Prevention Health Related Quality of Life Scale
Time frame: Baseline and 6 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.
9 secondary outcomes
Cardiovascular Health Score
Time frame: 12 Months
Metabolic Syndrome
Time frame: Baseline, 6 Months, and 12 Months
Centers for Disease Control and Prevention Health Related Quality of Life Scale
Time frame: 12 Months
Services utilization
Time frame: Baseline, 6 Months, and 12 Months
Perceived Stress Scale
Time frame: Baseline, 6 Months, and 12 Months
Center for Epidemiologic Studies Depression Scale 10
Time frame: Baseline, 6 Months, and 12 Months
Medical Outcomes Study Social Support Survey
Time frame: Baseline, 6 Months, and 12 Months
Motivation and Attitudes Toward Changing Health
Time frame: Baseline, 6 Months, and 12 Months
Brief Resilience Scale
Time frame: Baseline, 6 Months, and 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Sykes, PhD, MPH principal investigator
Baylor Scott & White Health and Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Quality of Life, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Health Score (time frame: Baseline and 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.