Clinical trial NCT06950775: The Neighborhood & Health Study
Official title: A Naturalistic Study of Residents of an Agriculturally Integrated Community
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy Eating
Cardiometabolic Health Indicators
Keywords: Agrihood
Physical Activity
Healthy Eating
Social Connectedness
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population the groups will be selected from are residents of the Indigo Neighborhood and Elyson Neighborhood in Fort Bent County, Texas

Brief summary: The objective of The Neighborhood \& Health Study is to use a quasi-experimental mixed-methods approach to assess the impact of living in an agrihood-an agriculturally integrated community. This study follows a longitudinal cohort of residents of a newly developed neighborhood (the Indigo Neighborhood) and a geographically and socio-demographically matched neighborhood (the Elyson Neighborhood), both located in Fort Bend County, Texas, providing a unique opportunity for a natural experiment.

Detailed description: Poor nutrition and inadequate physical activity are prevalent in many communities across the United States. Agriculturally integrated communities called "agrihoods" are a potential responsive agriculture solution that may support healthy living. The aims of the study are to 1) Assess short-term changes in healthy eating, physical activity, cardiometabolic health indicators, and social connectedness as compared to a comparison neighborhood that is not an agriculturally integrated neighborhood; 2) Document time use with features of the Indigo Agrihood and assess consumer preferences for built and nature design features to provide resident-driven data for future developments; 3) Assess the economic benefits of the Indigo Agrihood.

Eligibility criteria: Inclusion Criteria:

Indigo Neighborhood Participants:

* 18 years or older
* Lived in the Indigo Neighborhood for less than 3 months or intend to move. to the Indigo Neighborhood by July 31, 2025.

Elyson Neighborhood Participants:

* 18 years or older
* Live in the Elyson Neighborhood (the comparison neighborhood group).

Exclusion Criteria:

Indigo Neighborhood Participants:

• Pregnant women.

Elyson Neighborhood Participants:

• Pregnant women.

Primary outcomes:
measure: Change in healthy eating
timeFrame: Baseline to 3 & 6 months
measure: Change in physical activity
timeFrame: Baseline to 3 & 6 months
measure: Change in body mass index (BMI)
timeFrame: Baseline to 3 & 6 months
measure: Change in blood pressure
timeFrame: Baseline to 3 & 6 months
measure: Change in hemoglobin A1c
timeFrame: Baseline to 3 & 6 months
measure: Change in social connectedness
timeFrame: Baseline to 3 & 6 months
Secondary outcomes:
measure: Change in total physical activity
timeFrame: Baseline to 3 & 6 months
measure: Change in dermal carotenoids
timeFrame: Baseline to 3 & 6 months
measure: Change in lipids
timeFrame: Baseline to 3 & 6 months
measure: Change in total HEI score
timeFrame: Baseline to 3 & 6 months
measure: Change in fruit and vegetable intake
timeFrame: Baseline to 3 & 6 months
measure: Change in consumption of whole grains
timeFrame: Baseline to 3 & 6 months
measure: Change in fiber intake
timeFrame: Baseline to 3 & 6 months
measure: Met recommendation for fish consumption (y/n)
timeFrame: Baseline to 3 & 6 months
measure: Change in frequency of consuming ultra-processed foods
timeFrame: Baseline to 3 & 6 months
measure: Change in red and processed meat consumption
timeFrame: Baseline to 3 & 6 months
measure: Change in alcohol consumption
timeFrame: Baseline to 3 & 6 months
measure: Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score
timeFrame: Baseline to 3 & 6 months
measure: Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score
timeFrame: Baseline to 3 & 6 months
measure: Change in American Heart Association's Life's Essential 8 (LE8) cardiovascular health score
timeFrame: Baseline to 3 & 6 months
measure: Change in community food environment
timeFrame: Baseline to 3 & 6 months
measure: Change in perceived stress
timeFrame: Baseline to 3 & 6 months
measure: Change in gardening and fruit and vegetable procurement
timeFrame: Baseline to 3 & 6 months
measure: Change in sense of community
timeFrame: Baseline to 3 & 6 months
measure: Change in nature exposure
timeFrame: Baseline to 3 & 6 months
measure: Change in positive and negative affect
timeFrame: Baseline to 3 & 6 months
measure: Change in (community) social cohesion
timeFrame: Baseline to 3 & 6 months
measure: Change in transportation used to utilized food resources
timeFrame: Baseline to 3 & 6 months
measure: Change in distance to utilized food resources
timeFrame: Baseline to 3 & 6 months
measure: Change in number of utilized food resources
timeFrame: Baseline to 3 & 6 months
measure: Change in transportation used to utilized physical activity resources
timeFrame: Baseline to 3 & 6 months
measure: Change in distance to utilized physical activity resources
timeFrame: Baseline to 3 & 6 months
measure: Change in number of utilized physical activity resources
timeFrame: Baseline to 3 & 6 months
measure: Change in loneliness
timeFrame: Baseline to 3 & 6 months
measure: Change in functional health
timeFrame: Baseline to 3 & 6 months
Other outcomes:
Locations:
city: Katy
country: United States
facility: Elyson Neighborhood
state: Texas
city: Richmond
country: United States
facility: Indigo Neighborhood
state: Texas
Study officials:
affiliation: Texas A&M University
name: Jay E Maddock, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: