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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Residence in Agrihood Neighborhood
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas A&M University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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