Clinical trial NCT06044831: Expanded Population Health Model Evaluation
Official title: Evaluating BSW HWC's Population Health Model Expansion At Bonton Farms: a Place-Based Quasi-Experimental Study Linking Medical and Social Services
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Disease
Quality of Life
Keywords: Life Essential 8
Cardiovascular Disease
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Southern Star Medical Research Institute
First posted: 2023-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants living in the neighborhood with access to expanded population health model.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular Health Score
timeFrame: Baseline and 6 Months
measure: Centers for Disease Control and Prevention Health Related Quality of Life Scale
timeFrame: Baseline and 6 Months
Secondary outcomes:
measure: Cardiovascular Health Score
timeFrame: 12 Months
measure: Metabolic Syndrome
timeFrame: Baseline, 6 Months, and 12 Months
measure: Centers for Disease Control and Prevention Health Related Quality of Life Scale
timeFrame: 12 Months
measure: Services utilization
timeFrame: Baseline, 6 Months, and 12 Months
measure: Perceived Stress Scale
timeFrame: Baseline, 6 Months, and 12 Months
measure: Center for Epidemiologic Studies Depression Scale 10
timeFrame: Baseline, 6 Months, and 12 Months
measure: Medical Outcomes Study Social Support Survey
timeFrame: Baseline, 6 Months, and 12 Months
measure: Motivation and Attitudes Toward Changing Health
timeFrame: Baseline, 6 Months, and 12 Months
measure: Brief Resilience Scale
timeFrame: Baseline, 6 Months, and 12 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Health and Wellness Center
state: Texas
Study officials:
affiliation: Baylor Scott & White Health and Wellness Center
name: Leilani Dodgen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: