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

Sponsor

Cornell University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02770196

Collaborator

University of Vermont (Other), University of North Carolina, Chapel Hill (Other), The Evergreen State College (Other)

305

Enrollment

Locations

Arms

71.4

Duration (Months)

10.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity Child Nutrition Disorders	Behavioral: CO-CSA plus Nutrition Education	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

305 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Dec 6, 2018

Anticipated Study Completion Date :

Mar 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group One (Two-year Intervention, 2016 Enrollment) Group 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.	Behavioral: CO-CSA plus Nutrition Education 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.
Experimental: Group Two (Delayed Two-year Intervention, 2016 Enrollment) Group 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.	Behavioral: CO-CSA plus Nutrition Education 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.
Experimental: Group Three (One-year Intervention, 2017 Enrollment) Group 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.	Behavioral: CO-CSA plus Nutrition Education 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.
Experimental: Group Four (Delayed One-year Intervention, 2017 Enrollment) Group 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.	Behavioral: CO-CSA plus Nutrition Education 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.

Outcome Measures

Primary Outcome Measures

Change in child's fruit and vegetable intake as measured by short dietary screener [Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up]
Data collected using the National Cancer Institute's All-Day Fruit and Vegetable Screener.
Change in child's fruit and vegetable intake as measured by 24-hour dietary recall [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system
Change in child's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire [Baseline to 4 months, 12-month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up]
Data collected using the Fred Hutchison Cancer Research Center's 'Beverage and Snack Questionnaire 2'
Change in child's intake of sugar-sweetened beverages and processed snacks as measured by 24-hour dietary recall [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system
Change in child's caloric intake as a percent of estimated energy requirements [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system
Change in child's dermal carotenoid levels [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Carotenoid levels measured by resonance Raman spectroscopy using the Bio-Photonic Scanner (NuSkin Enterprises)
Change in child's diet quality [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system

Secondary Outcome Measures

Change in child's BMI percentile [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Height and weight measured by trained research staff
Change in child's physical activity [Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up]
Data collected using survey question on physical activity adapted from Youth Risk Behavior Surveillance System (YRBSS) questionnaire
Change in child's sedentary behavior [Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up]
Data collected using survey questions on TV, video, and computer use adapted from Youth Risk Behavior Surveillance System (YRBSS) questionnaire
Changes in parent's ability to select, store, and prepare CSA produce [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected using questionnaire module on parent's ability to select, store, and prepare CSA produce
Changes in parent's ability to prepare foods to minimize added (solid) fat and sugar [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected using questionnaire module on parent's ability to prepare foods to minimize added (solid) fat and sugar
Changes in parent's ability to substitute fruit and vegetables for energy-dense foods [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected using questionnaire module on parent's ability to substitute fruit and vegetables for energy-dense foods
Changes in parent's knowledge, attitudes, and beliefs about fruits and vegetables [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected using questionnaire module on parent's knowledge, attitudes, and beliefs about fruits and vegetables
Changes in availability and accessibility of fruits and vegetables in the home [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Data collected using questionnaire module on the availability and accessibility of fruits and vegetables in the home
Change in parent's fruit and vegetable intake as measured by short dietary screener [Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up]
Data collected using the National Cancer Institute's All-Day Fruit and Vegetable Screener
Change in parent's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire [Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up]
Data collected using the Fred Hutchison Cancer Research Center's 'Beverage and Snack Questionnaire 2'
Change in parent's dermal carotenoid levels [Baseline to 4 months, 16-month follow-up, and 28-month follow-up]
Carotenoid levels measured by resonance Raman spectroscopy using the Bio-Photonic Scanner (NuSkin Enterprises)
Changes in household food security [Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up]
Data collected using the USDA 6-item Food Security Survey Module with 30-day reference period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barker	Barker	New York	United States	14012
2	Corning	Corning	New York	United States	14830
3	Gasport	Gasport	New York	United States	14067
4	Lockport	Lockport	New York	United States	14094
5	Medina	Medina	New York	United States	14103
6	Newfane	Newfane	New York	United States	14108
7	Watertown	Watertown	New York	United States	13601
8	Chapel Hill	Chapel Hill	North Carolina	United States	27510; 27514; 27515
9	Chapel Hill	Chapel Hill	North Carolina	United States	27516; 27517; 27599; 27707
10	Pittsboro	Pittsboro	North Carolina	United States	23712
11	Siler City	Siler City	North Carolina	United States	27344
12	Bristol	Bristol	Vermont	United States	05443; 05472
13	Burlington	Burlington	Vermont	United States	05401; 05402; 05405
14	Burlington	Burlington	Vermont	United States	05406; 05408
15	Cuttingsville	Cuttingsville	Vermont	United States	05738
16	Hinesburg	Hinesburg	Vermont	United States	05461; 05462; 05445
17	Ludlow	Ludlow	Vermont	United States	05149
18	Rutland	Rutland	Vermont	United States	05701; 05702; 05736
19	Rutland	Rutland	Vermont	United States	05759; 05765
20	South Burlington	South Burlington	Vermont	United States	05407; 05403; 05482
21	Starksboro	Starksboro	Vermont	United States	05461; 05473
22	Starksboro	Starksboro	Vermont	United States	05487; 05469; 05443
23	Vergennes	Vergennes	Vermont	United States	05491
24	Winooski	Winooski	Vermont	United States	05404; 05439; 05446; 05449
25	La Conner	La Conner	Washington	United States	98257
26	Mount Vernon	Mount Vernon	Washington	United States	98274
27	Olympia	Olympia	Washington	United States	98502
28	Rochester	Rochester	Washington	United States	98579
29	Sedro Woolley	Sedro-Woolley	Washington	United States	98284

Sponsors and Collaborators

Cornell University
University of Vermont
University of North Carolina, Chapel Hill
The Evergreen State College

Investigators

Principal Investigator: Rebecca A. Seguin, PhD, Cornell University
Principal Investigator: Karla Hanson, PhD, Cornell University
Principal Investigator: Jane Kolodinsky, PhD, University of Vermont
Principal Investigator: Marilyn Sitaker, PhD, The Evergreen State College
Principal Investigator: Alice Ammerman, PhD, University of North Carolina, Chapel Hill
Principal Investigator: Stephanie Jilcott-Pitts, PhD, East Carolina University