- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950775
The Neighborhood & Health Study (N&HS)
December 5, 2025 updated by: Texas A&M University
A Naturalistic Study of Residents of an Agriculturally Integrated Community
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deyaun L Jafari, Ph.D.
- Phone Number: 972-952-9215
- Email: deyaun.jafari@ag.tamu.edu
Study Locations
-
-
Texas
-
Katy, Texas, United States, 77493
- Recruiting
- Elyson Neighborhood
-
Contact:
- Project Manager
-
Richmond, Texas, United States, 77406
- Recruiting
- Indigo Neighborhood
-
Contact:
- Project Manager
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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
Description
Inclusion Criteria:
Indigo Neighborhood Participants:
- 18 years or older
- Lived in the Indigo Neighborhood as their primary and permanent residence for less than 3 months or intend to move to the Indigo Neighborhood as their primary and permanent residence.
- Pregnant women will not be excluded from participation and may be coincidentally included
Elyson Neighborhood Participants:
- 18 years or older
- Live in the Elyson Neighborhood as their primary and permanent residence (the comparison neighborhood group).
- Pregnant women will not be excluded from participation and may be coincidentally included
Exclusion Criteria:
Indigo Neighborhood Participants:
• None.
Elyson Neighborhood Participants:
• None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Agrihood Group
The Agrihood Group consists of adults who live in the Indigo Neighborhood as their primary and permanent residence for less than 3 months or intend to move to the Indigo Neighborhood as their primary and permanent residence.
Pregnant women will not be excluded from participation and may be coincidentally included.
|
We are examining the effects of individuals who move into an agrihood neighborhood.
|
|
Comparison Group
The Comparison Group consists of adults who live in the Elyson comparison neighborhood as their primary and permanent residence.
Pregnant women will not be excluded from participation and may be coincidentally included.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in healthy eating
Time Frame: Baseline to 3 & 6 months
|
Healthy eating will be measured by the Mediterranean Eating Pattern for Americans - 16 items scale.
Score ranges from 0 to 16.
Higher scores indicate healthy eating patterns.
|
Baseline to 3 & 6 months
|
|
Change in physical activity
Time Frame: Baseline to 3 & 6 months
|
Physical activity will be measured through calculating moderate to vigorous physical activity (MVPA), light, moderate, and vigorous physical activity (LMVPA), walking, and sedentary behavior using data from an accelerometer worn by participants for 7 days
|
Baseline to 3 & 6 months
|
|
Change in social connectedness
Time Frame: Baseline to 3 & 6 months
|
Social connectedness will be measured by the Brief Sense of Community Scale.
Scores range from 8 to 40.
Higher scores indicate more social connectedness.
|
Baseline to 3 & 6 months
|
|
Change in body mass index (BMI)
Time Frame: Baseline to 6 months
|
Height and weight will be measured by research staff and BMI will be calculated.
|
Baseline to 6 months
|
|
Change in blood pressure
Time Frame: Baseline to 6 months
|
Blood pressure will be measured by research staff using an Omron sphygmomanometer.
Measured in units of millimeters of mercury (mmHg).
|
Baseline to 6 months
|
|
Change in hemoglobin A1c
Time Frame: Baseline to 6 months
|
Hemoglobin A1c will be measured by research staff using a CardioChek Plus machine that measures glucose in their blood.
Hemoglobin A1c is measured in milligrams (mg) per deciliter (dL) of blood.
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in total physical activity
Time Frame: Baseline to 3 & 6 months
|
Total physical activity (MET-min/wk) will be assessed using the International Physical Activity Questionnaire short form (IPAQ-long)
|
Baseline to 3 & 6 months
|
|
Change in total HEI score
Time Frame: Baseline to 3 & 6 months
|
Total Healthy Eating Index (HEI) score will be calculated from a single 24-hour recall collected via the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24).
Score ranges from 0 to 100.
Higher scores indicate better diet.
|
Baseline to 3 & 6 months
|
|
Met recommendation for fish consumption (y/n)
Time Frame: Baseline to 3 & 6 months
|
Whether or not a participant met the recommendation for fish consumption will be assessed using an LS7 item.
|
Baseline to 3 & 6 months
|
|
Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score
Time Frame: Baseline to 3 & 6 months
|
American Heart Association's Life's Simple 7 (LS7) score is a composite of cardiovascular disease (CVD) risk factors (physical activity, eating habits, smoking status, cholesterol, glucose, body mass index (BMI), and blood pressure).
Score ranges from 0 to 14. Higher scores indicate better health.
|
Baseline to 3 & 6 months
|
|
Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score
Time Frame: Baseline to 3 & 6 months
|
WCRF/AICR recommendation adherence score is a composite of seven items listed above: BMI, physical activity, fiber intake, fruit and vegetable consumption, processed food consumption, red meat consumption, and alcohol consumption.
Scores range from 0 to 7. Higher scores indicate greater adherence to the recommendations.
|
Baseline to 3 & 6 months
|
|
Change in American Heart Association's Life's Essential 8 (LE8) cardiovascular health score
Time Frame: Baseline to 3 & 6 months
|
American Heart Association's Life's Essential 8 (LE8) score is a composite of cardiovascular disease (CVD) risk factors (physical activity, eating habits, smoking status, sleep, cholesterol, glucose, body mass index (BMI), and blood pressure).
Score ranges from 0 to 100.
Higher scores indicate better health.
|
Baseline to 3 & 6 months
|
|
Change in community food environment
Time Frame: Baseline to 3 & 6 months
|
The community food environment, including store access and shopping behaviors, will be assessed by two items from the Perceived Nutrition Environment Measures Survey.
Scores range from 2 to 10. Higher scores indicate a more diverse community food environment
|
Baseline to 3 & 6 months
|
|
Change in perceived stress
Time Frame: Baseline to 3 & 6 months
|
Perceived stress will be assessed by the Perceived Stress Scale.
Scores range from 0 to 40.
Higher scores indicate more perceived stress.
|
Baseline to 3 & 6 months
|
|
Change in gardening and fruit and vegetable procurement
Time Frame: Baseline to 3 & 6 months
|
Types of gardening and where fruits and vegetables are obtained will be assessed using multiple choice questions.
|
Baseline to 3 & 6 months
|
|
Change in sense of community
Time Frame: Baseline to 3 & 6 months
|
Sense of community will be assessed using the Collective Efficacy scale.
Scores range from 5 to 25.
Higher scores indicate greater sense of community.
|
Baseline to 3 & 6 months
|
|
Change in nature exposure
Time Frame: Baseline to 3 & 6 months
|
Nature exposure will be assessed by modified questions from the People and Nature Survey for England for American audiences.
Multiple choice questions assess how much time is spent in nature and what type of natural spaces individuals visit.
An additional multiple-choice item from the Nature of Americans survey will be used to identify how much time is spent in nature recreationally and for work in a typical week in hours.
|
Baseline to 3 & 6 months
|
|
Change in positive and negative affect
Time Frame: Baseline to 3 & 6 months
|
Positive and negative affect will be assessed by the Positive and Negative Affect Scale.
Scores range from 10 to 50 for each positive and negative affect.
Higher scores indicate more positive or negative affect.
|
Baseline to 3 & 6 months
|
|
Change in (community) social cohesion
Time Frame: Baseline to 3 & 6 months
|
Community social cohesion will be assessed by the social cohesion sub-scale of the Mujahid et al.
Neighborhood Environment Scale (NES).
Scores range from 1 to 5. Higher scores indicate greater social cohesion.
|
Baseline to 3 & 6 months
|
|
Change in transportation used to utilized food resources
Time Frame: Baseline to 3 & 6 months
|
Transportation used to obtain food will be assessed by a single categorical item.
|
Baseline to 3 & 6 months
|
|
Change in distance to utilized food resources
Time Frame: Baseline to 3 & 6 months
|
Distance to utilized food resources will be measured in miles.
|
Baseline to 3 & 6 months
|
|
Change in number of utilized food resources
Time Frame: Baseline to 3 & 6 months
|
Number of utilized food resources will be measured by a multiple choice item.
|
Baseline to 3 & 6 months
|
|
Change in transportation used to utilized physical activity resources
Time Frame: Baseline to 3 & 6 months
|
Transportation used to access the physical activity resources will be assessed by a single categorical item.
|
Baseline to 3 & 6 months
|
|
Change in distance to utilized physical activity resources
Time Frame: Baseline to 3 & 6 months
|
Distance to utilized physical activity resources will be measured in miles.
|
Baseline to 3 & 6 months
|
|
Change in number of utilized physical activity resources
Time Frame: Baseline to 3 & 6 months
|
Number of utilized physical activity resources will be measured by a multiple choice item.
|
Baseline to 3 & 6 months
|
|
Change in loneliness
Time Frame: Baseline to 3 & 6 months
|
Loneliness and social isolation will be assessed by the UCLA Loneliness Scale.
Scores range from 20 to 80. Higher scores indicate more loneliness and social isolation.
|
Baseline to 3 & 6 months
|
|
Change in functional health
Time Frame: Baseline to 3 & 6 months
|
Functional health will be assessed by the Quality Metric's MOS Short Form - 36 Version 2. 10 items will be used with scores range from 0 to 20.
Higher scores indicate higher functional health.
|
Baseline to 3 & 6 months
|
|
Change in dermal carotenoids
Time Frame: Baseline to 6 months
|
Dermal carotenoids will be measured by research staff using a Veggie Meter machine, which scans a participant's finger to measure carotenoids or how many fruits and vegetables someone eats.
Scores from 0 to 800.
Higher scores indicate higher levels of carotenoids.
|
Baseline to 6 months
|
|
Change in lipids
Time Frame: Baseline to 6 months
|
Lipids will be measured by research staff using a CardioChek Plus machine that measures lipids in blood.
Triglycerides will be measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.
LDL/HDL cholesterol will be measured in milligrams of LDL/HDL cholesterol per deciliter (dL) of blood.
Total Cholesterol is measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.
|
Baseline to 6 months
|
|
Change in fruit intake
Time Frame: Baseline to 3 & 6 months
|
Total fruit intake (cups/day) will be measured using a LS7 item.
|
Baseline to 3 & 6 months
|
|
Change in vegetable intake
Time Frame: Baseline to 3 & 6 months
|
Total vegetable intake (cups/day) will be measured using a LS7 item.
|
Baseline to 3 & 6 months
|
|
Change in consumption of whole grains
Time Frame: Baseline to 3 & 6 months
|
Whole grain consumption (servings/day) will be assessed using an LS7 item.
|
Baseline to 3 & 6 months
|
|
Change in fiber intake
Time Frame: Baseline to 3 & 6 months
|
Fiber intake (g/day) will be assessed using the NHANES Dietary Screener Questionnaire (DSQ).
|
Baseline to 3 & 6 months
|
|
Change in frequency of consuming ultra-processed foods
Time Frame: Baseline to 3 & 6 months
|
Frequency of ultra-processed foods consumption (times/month) will be assessed using a 9-item questionnaire adapted from the DSQ and the Beverage and Snack Questionnaire (BSQ2).
|
Baseline to 3 & 6 months
|
|
Change in red and processed meat consumption
Time Frame: Baseline to 3 & 6 months
|
Total red and processed meat consumption (g/week) will be estimated using the DSQ.
|
Baseline to 3 & 6 months
|
|
Change in alcohol consumption
Time Frame: Baseline to 3 & 6 months
|
Alcohol consumption (drinks/day) will be assessed using a 2-item questionnaire adapted from the Alcohol Use Disorders Screening Test (AUDIT).
|
Baseline to 3 & 6 months
|
|
Change in fruit intake
Time Frame: Baseline to 3 & 6 months
|
Total fruit intake (cups/day) will be measured using a 24-hour recall.
|
Baseline to 3 & 6 months
|
|
Change in vegetable intake
Time Frame: Baseline to 3 & 6 months
|
Total vegetable intake (cups/day) will be measured using a 24-hour recall.
|
Baseline to 3 & 6 months
|
|
Change in consumption of whole grains
Time Frame: Baseline to 3 & 6 months
|
Whole grain consumption (servings/day) will be assessed using a 24-hour recall.
|
Baseline to 3 & 6 months
|
|
Change in fiber intake
Time Frame: Baseline to 3 & 6 months
|
Fiber intake (g/day) will be assessed using a 24-hour recall.
|
Baseline to 3 & 6 months
|
|
Change in red and processed meat consumption
Time Frame: Baseline to 3 & 6 months
|
Total red and processed meat consumption (g/week) will be estimated using a 24-hour recall.
|
Baseline to 3 & 6 months
|
|
Change in alcohol consumption
Time Frame: Baseline to 3 & 6 months
|
Alcohol consumption (drinks/day) will be assessed using a 24-hour recall.
|
Baseline to 3 & 6 months
|
|
Change in frequency of consuming ultra-processed foods
Time Frame: Baseline to 3 & 6 months
|
Frequency of ultra-processed foods consumption (times/month) will be assessed using a 24-hour recall.
|
Baseline to 3 & 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jay E Maddock, Ph.D., Texas A&M University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
April 22, 2025
First Submitted That Met QC Criteria
April 22, 2025
First Posted (Actual)
April 30, 2025
Study Record Updates
Last Update Posted (Estimated)
December 9, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY2025-0321
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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