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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02770196
• Other study ID #: IRB #: 1501005266
• Secondary ID: 2015-68001-23230
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: March 14, 2021

Study information

• Verified date: July 2019
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 305
• Est. completion date: March 14, 2021
• Est. primary completion date: December 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Nutrition Disorders
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Barker	Barker	New York
United States	Bristol	Bristol	Vermont
United States	Burlington	Burlington	Vermont
United States	Burlington	Burlington	Vermont
United States	Chapel Hill	Chapel Hill	North Carolina
United States	Chapel Hill	Chapel Hill	North Carolina
United States	Corning	Corning	New York
United States	Cuttingsville	Cuttingsville	Vermont
United States	Gasport	Gasport	New York
United States	Hinesburg	Hinesburg	Vermont
United States	La Conner	La Conner	Washington
United States	Lockport	Lockport	New York
United States	Ludlow	Ludlow	Vermont
United States	Medina	Medina	New York
United States	Mount Vernon	Mount Vernon	Washington
United States	Newfane	Newfane	New York
United States	Olympia	Olympia	Washington
United States	Pittsboro	Pittsboro	North Carolina
United States	Rochester	Rochester	Washington
United States	Rutland	Rutland	Vermont
United States	Rutland	Rutland	Vermont
United States	Sedro Woolley	Sedro-Woolley	Washington
United States	Siler City	Siler City	North Carolina
United States	South Burlington	South Burlington	Vermont
United States	Starksboro	Starksboro	Vermont
United States	Starksboro	Starksboro	Vermont
United States	Vergennes	Vergennes	Vermont
United States	Watertown	Watertown	New York
United States	Winooski	Winooski	Vermont

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
Primary	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	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Primary	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'	Baseline to 4 months, 12-month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
Primary	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	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Primary	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	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Primary	Change in child's dermal carotenoid levels	Carotenoid levels measured by resonance Raman spectroscopy using the Bio-Photonic Scanner (NuSkin Enterprises)	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Primary	Change in child's diet quality	Data collected with dietary recalls using the online Automated Self-Administered 24-Hour Dietary Recall (ASA24) system	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary	Change in child's BMI percentile	Height and weight measured by trained research staff	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary	Change in child's physical activity	Data collected using survey question on physical activity adapted from Youth Risk Behavior Surveillance System (YRBSS) questionnaire	Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
Secondary	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	Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
Secondary	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	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary	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	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary	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	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary	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	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary	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	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary	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	Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
Secondary	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'	Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
Secondary	Change in parent's dermal carotenoid levels	Carotenoid levels measured by resonance Raman spectroscopy using the Bio-Photonic Scanner (NuSkin Enterprises)	Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary	Changes in household food security	Data collected using the USDA 6-item Food Security Survey Module with 30-day reference period	Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up