AzTrials
AzTrials

Pediatric ObesityNCT02770196

Intervention Study of Cost-Offset Community Supported Agriculture (CO-CSA)

A study testing CO-CSA plus Nutrition Education in people with Pediatric Obesity and Child Nutrition Disorders, run by Cornell University at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to better understand how participation in cost-subsidized community supported agriculture programs paired with tailored education can affect diet quality and energy balance among children in low-income households. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pediatric Obesity, Child Nutrition Disorders
What is being tested?
CO-CSA plus Nutrition Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
29 sitesUnited States
Study dates
Apr 2015to 14 Mar 2021
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English-speaking
  • Parent or legal guardian of a child in the household between the ages of two and 12 years
  • Self-reported income less than 185% of the Federal Poverty Level or report enrollment in SNAP, WIC, or Head Start
  • Has access to a computer from which s/he can complete on-line data collection
  • Has an active e-mail account or willing to create an e-mail account
  • Has not participated in CSA in the past three years
Show all 11Show fewer
  • Willing to purchase the 50% CO-CSA share (can use SNAP benefits if desired and available)
  • Willing to attend CSA-tailored education sessions
  • Willing to make a firm commitment to three years of participation (2016 enrollment) or two years of participation (2017 enrollment), with timing of the off-set benefit determined by randomization
  • Complete baseline survey
  • Pay deposit to farm

Who cannot join

  • Non-English-speaking
  • Not the parent or legal guardian of a child in the household between the ages of two and 12 years
  • Self-reported income equal to or greater than 185% of the Federal Poverty Level and no report of SNAP, WIC, or Head Start enrollment
  • Does not have access to a computer from which s/he can complete on-line data collection
  • Does not have an active e-mail account or is not able or willing to create an e-mail account
  • Has participated in CSA in the past three years
Show all 11Show fewer
  • Not able or willing to purchase the 50% CO-CSA share
  • Not able or willing to attend CSA-tailored education sessions
  • Not able or willing to make a firm commitment to three years of participation (for 2016 enrollment) or two years of participation (2017 enrollment), with timing of the off-set benefit determined by randomization
  • Not able or willing to complete baseline survey
  • Not able or willing to pay deposit to farm

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Barker

    Barker, New York, 14012

  • Bristol

    Bristol, Vermont, 05443; 05472

  • Burlington

    Burlington, Vermont, 05401; 05402; 05405

  • Burlington

    Burlington, Vermont, 05406; 05408

  • Chapel Hill

    Chapel Hill, North Carolina, 27510; 27514; 27515

  • Chapel Hill

    Chapel Hill, North Carolina, 27516; 27517; 27599; 27707

  • Corning

    Corning, New York, 14830

  • Cuttingsville

    Cuttingsville, Vermont, 05738

  • Gasport

    Gasport, New York, 14067

  • Hinesburg

    Hinesburg, Vermont, 05461; 05462; 05445

  • La Conner

    La Conner, Washington, 98257

  • Lockport

    Lockport, New York, 14094

  • Ludlow

    Ludlow, Vermont, 05149

  • Medina

    Medina, New York, 14103

  • Mount Vernon

    Mount Vernon, Washington, 98274

  • Newfane

    Newfane, New York, 14108

  • Olympia

    Olympia, Washington, 98502

  • Pittsboro

    Pittsboro, North Carolina, 23712

  • Rochester

    Rochester, Washington, 98579

  • Rutland

    Rutland, Vermont, 05701; 05702; 05736

  • Rutland

    Rutland, Vermont, 05759; 05765

  • Sedro Woolley

    Sedro-Woolley, Washington, 98284

  • Siler City

    Siler City, North Carolina, 27344

  • South Burlington

    South Burlington, Vermont, 05407; 05403; 05482

  • Starksboro

    Starksboro, Vermont, 05461; 05473

  • Starksboro

    Starksboro, Vermont, 05487; 05469; 05443

  • Vergennes

    Vergennes, Vermont, 05491

  • Watertown

    Watertown, New York, 13601

  • Winooski

    Winooski, Vermont, 05404; 05439; 05446; 05449

Other trials in United States

About this study

Official title: Farm Fresh Foods for Healthy Kids: Innovative Community Supported Agriculture Cost-Offset Intervention to Prevent Childhood Obesity and Strengthen Local Agricultural Economies

The purpose of this study is to better understand how participation in cost-subsidized community supported agriculture programs paired with tailored education can affect diet quality and energy balance among children in low-income households.

Read the detailed description

Community Supported Agriculture (CSA) is an innovative approach to increasing consumer access to and consumption of fresh produce, thereby lowering obesity prevalence. However, CSA "share" costs may be a barrier for low-income households with children. This multistate study examines whether subsidizing the cost of CSAs, integrated with tailored education: 1) increases consumption of fruits and vegetables, 2) substitutes fruits and vegetables for more energy-dense foods, and 3) improves overall diet quality and energy balance, thus helping children maintain healthy body weights. It also investigates how cost-offset CSAs ("CO-CSAs") contribute to local agricultural economies. Given the well-documented risk for obesity and limited access to fresh produce among low-income individuals, those households are the target of the intervention in four geographically-diverse states: Vermont, New York, North Carolina and Washington.

FORMATIVE AND LONGITUDINAL RESEARCH: Qualitative and quantitative research is being used to inform implementation of the randomized trial, refine outcome assessment strategies, and provide information needed to design a tailored curriculum to enhance low-income households' knowledge, skills, attitudes, and behaviors related to the use of CSA produce and healthy eating.

In the first year of the study, the investigators conducted interviews and focus groups with stakeholders to gather in-depth data related to the potential of CO-CSA operations to meet the needs and preferences of low-income households and the types of information that would be most valuable to include in the study's curriculum. Key stakeholder groups included adults and children from low-income households, CSA farmers, current full-paying CSA members, and nutrition educators.

The investigators also are conducting a longitudinal quantitative examination of dietary behaviors among current CO-CSA participants in an existing statewide program in Vermont. Using online surveys, the investigators are measuring dietary outcomes quarterly among children, and biannually among adults, from low-income households in the program. Data from Year 1 was used to inform the intervention, while data from subsequent time points will provide an opportunity for analysis of longitudinal patterns.

RANDOMIZED INTERVENTION: In the second phase of the project, the investigators will implement and evaluate a three-year delayed intervention randomized controlled trial of CO-CSA plus skill-based, CSA-tailored education in the four states. The investigators will compare changes in dietary behaviors, reported consumption, energy intake, and weight status parameters between children aged 2-12 in 120 control and 120 intervention households. Two hundred households were enrolled in 2016 and an additional 40 households will be enrolled in 2017. Participant households enrolled in 2016 will receive a CO-CSA share for two seasons and education during their first CO-CSA season (Y1 for intervention households and Y2 for control households). Households enrolled in 2017 will receive a CO-CSA share and education for one season (Y2 for intervention households and Y3 for control households). In addition to outcomes with participants, investigators will conduct economic analysis to evaluate the impact of CO-CSA for farms and communities. While these analyses are not related to the human participants, they are central to the overall project goals.

Being tested
CO-CSA plus Nutrition Education
Keywords
Community-Supported Agriculture, Local Food System, Vegetable, Fruit, Childhood Obesity
Medical subject headings
Pediatric Obesity, Child Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CO-CSA plus Nutrition EducationBehavioural

    Participants will receive subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year. In addition, they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.

Study groups in NCT02770196
Study groupRoleWhat they receive
Group One (Two-year Intervention, 2016 Enrollment)ExperimentalGroup one intervention participants in CO-CSA plus nutrition education will receive a subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year in 2016 and 2017. During the 2016 season they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
Receives: Behavioral: CO-CSA plus Nutrition Education
Group Two (Delayed Two-year Intervention, 2016 Enrollment)ExperimentalGroup two intervention participants in CO-CSA plus nutrition education will receive a subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year in 2017 and 2018. During the 2017 season they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
Receives: Behavioral: CO-CSA plus Nutrition Education
Group Three (One-year Intervention, 2017 Enrollment)ExperimentalGroup three intervention participants in CO-CSA plus nutrition education will receive a subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks in 2017 and will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
Receives: Behavioral: CO-CSA plus Nutrition Education
Group Four (Delayed One-year Intervention, 2017 Enrollment)ExperimentalGroup four delayed intervention participants in CO-CSA plus nutrition education will receive a subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks in 2018 and will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
Receives: Behavioral: CO-CSA plus Nutrition Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in child's fruit and vegetable intake as measured by short dietary screener

    Data collected using the National Cancer Institute's All-Day Fruit and Vegetable Screener.

    Measured: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up

  2. Change in child's fruit and vegetable intake as measured by 24-hour dietary recall

    Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  3. Change in child's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire

    Data collected using the Fred Hutchison Cancer Research Center's 'Beverage and Snack Questionnaire 2'

    Measured: Baseline to 4 months, 12-month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up

  4. Change in child's intake of sugar-sweetened beverages and processed snacks as measured by 24-hour dietary recall

    Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  5. Change in child's caloric intake as a percent of estimated energy requirements

    Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  6. Change in child's dermal carotenoid levels

    Carotenoid levels measured by resonance Raman spectroscopy using the Bio-Photonic Scanner (NuSkin Enterprises)

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  7. Change in child's diet quality

    Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

Secondary outcomes (12)

  1. Change in child's BMI percentile

    Height and weight measured by trained research staff

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  2. Change in child's physical activity

    Data collected using survey question on physical activity adapted from Youth Risk Behavior Surveillance System (YRBSS) questionnaire

    Measured: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up

  3. Change in child's sedentary behavior

    Data collected using survey questions on TV, video, and computer use adapted from Youth Risk Behavior Surveillance System (YRBSS) questionnaire

    Measured: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up

  4. Changes in parent's ability to select, store, and prepare CSA produce

    Data collected using questionnaire module on parent's ability to select, store, and prepare CSA produce

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  5. Changes in parent's ability to prepare foods to minimize added (solid) fat and sugar

    Data collected using questionnaire module on parent's ability to prepare foods to minimize added (solid) fat and sugar

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  6. Changes in parent's ability to substitute fruit and vegetables for energy-dense foods

    Data collected using questionnaire module on parent's ability to substitute fruit and vegetables for energy-dense foods

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  7. Changes in parent's knowledge, attitudes, and beliefs about fruits and vegetables

    Data collected using questionnaire module on parent's knowledge, attitudes, and beliefs about fruits and vegetables

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  8. Changes in availability and accessibility of fruits and vegetables in the home

    Data collected using questionnaire module on the availability and accessibility of fruits and vegetables in the home

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  9. Change in parent's fruit and vegetable intake as measured by short dietary screener

    Data collected using the National Cancer Institute's All-Day Fruit and Vegetable Screener

    Measured: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up

  10. Change in parent's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire

    Data collected using the Fred Hutchison Cancer Research Center's 'Beverage and Snack Questionnaire 2'

    Measured: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up

  11. Change in parent's dermal carotenoid levels

    Carotenoid levels measured by resonance Raman spectroscopy using the Bio-Photonic Scanner (NuSkin Enterprises)

    Measured: Baseline to 4 months, 16-month follow-up, and 28-month follow-up

  12. Changes in household food security

    Data collected using the USDA 6-item Food Security Survey Module with 30-day reference period

    Measured: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2016 (estimated)
  2. Study startApr 2015
  3. Primary completion6 Dec 2018
  4. Study completion14 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02770196
Sponsor's protocol ID
IRB #: 1501005266
Other IDs
2015-68001-23230, 2015
Status last verified
Feb 2026
First submitted
5 Apr 2016
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Garner JA, Hanson KL, Jilcott Pitts SB, Kolodinsky J, Sitaker MH, Ammerman AS, Kenkel D, Seguin-Fowler RA. Cost analysis and cost effectiveness of a subsidized community supported agriculture intervention for low-income families. Int J Behav Nutr Phys Act. 2023 Jul 10;20(1):84. doi: 10.1186/s12966-023-01481-7.

    PubMed 37430305

  • Seguin-Fowler RA, Hanson KL, Jilcott Pitts SB, Kolodinsky J, Sitaker M, Ammerman AS, Marshall GA, Belarmino EH, Garner JA, Wang W. Community supported agriculture plus nutrition education improves skills, self-efficacy, and eating behaviors among low-income caregivers but not their children: a randomized controlled trial. Int J Behav Nutr Phys Act. 2021 Aug 31;18(1):112. doi: 10.1186/s12966-021-01168-x.

    PubMed 34461931

  • Lu I, Hanson KL, Jilcott Pitts SB, Kolodinsky J, Ammerman AS, Sitaker M, Wang W, Volpe LC, Belarmino EH, Garner J, Gonsalves L, Seguin RA. Perceptions of nutrition education classes offered in conjunction with a community-supported agriculture intervention among low-income families. Public Health Nutr. 2021 Jul;24(10):3028-3036. doi: 10.1017/S1368980020002773. Epub 2020 Aug 24.

    PubMed 32830626

  • Seguin RA, Morgan EH, Hanson KL, Ammerman AS, Jilcott Pitts SB, Kolodinsky J, Sitaker M, Becot FA, Connor LM, Garner JA, McGuirt JT. Farm Fresh Foods for Healthy Kids (F3HK): An innovative community supported agriculture intervention to prevent childhood obesity in low-income families and strengthen local agricultural economies. BMC Public Health. 2017 Apr 8;17(1):306. doi: 10.1186/s12889-017-4202-2.

    PubMed 28390403

Questions about this trial

What is this clinical trial studying?

A study testing CO-CSA plus Nutrition Education in people with Pediatric Obesity and Child Nutrition Disorders, run by Cornell University at 29 sites 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 11 inclusion and 11 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites 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?

Change in child's fruit and vegetable intake as measured by short dietary screener (time frame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02770196, which also lists 4 linked publications.

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 9 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in