Clinical trial NCT02770196: Intervention Study of Cost-Offset Community Supported Agriculture (CO-CSA)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Child Nutrition Disorders
Keywords: Community-Supported Agriculture
Local Food System
Vegetable
Fruit
Childhood Obesity
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: University of Vermont
name: University of North Carolina, Chapel Hill
name: The Evergreen State College
First posted: 2016-05-12
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in child's fruit and vegetable intake as measured by short dietary screener
timeFrame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
measure: Change in child's fruit and vegetable intake as measured by 24-hour dietary recall
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Change in child's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire
timeFrame: Baseline to 4 months, 12-month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
measure: Change in child's intake of sugar-sweetened beverages and processed snacks as measured by 24-hour dietary recall
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Change in child's caloric intake as a percent of estimated energy requirements
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Change in child's dermal carotenoid levels
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Change in child's diet quality
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
Secondary outcomes:
measure: Change in child's BMI percentile
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Change in child's physical activity
timeFrame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
measure: Change in child's sedentary behavior
timeFrame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
measure: Changes in parent's ability to select, store, and prepare CSA produce
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Changes in parent's ability to prepare foods to minimize added (solid) fat and sugar
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Changes in parent's ability to substitute fruit and vegetables for energy-dense foods
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Changes in parent's knowledge, attitudes, and beliefs about fruits and vegetables
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Changes in availability and accessibility of fruits and vegetables in the home
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Change in parent's fruit and vegetable intake as measured by short dietary screener
timeFrame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
measure: Change in parent's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire
timeFrame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
measure: Change in parent's dermal carotenoid levels
timeFrame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up
measure: Changes in household food security
timeFrame: Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up
Other outcomes:
Locations:
city: Barker
country: United States
facility: Barker
state: New York
city: Corning
country: United States
facility: Corning
state: New York
city: Gasport
country: United States
facility: Gasport
state: New York
city: Lockport
country: United States
facility: Lockport
state: New York
city: Medina
country: United States
facility: Medina
state: New York
city: Newfane
country: United States
facility: Newfane
state: New York
city: Watertown
country: United States
facility: Watertown
state: New York
city: Chapel Hill
country: United States
facility: Chapel Hill
state: North Carolina
city: Chapel Hill
country: United States
facility: Chapel Hill
state: North Carolina
city: Pittsboro
country: United States
facility: Pittsboro
state: North Carolina
city: Siler City
country: United States
facility: Siler City
state: North Carolina
city: Bristol
country: United States
facility: Bristol
state: Vermont
city: Burlington
country: United States
facility: Burlington
state: Vermont
city: Burlington
country: United States
facility: Burlington
state: Vermont
city: Cuttingsville
country: United States
facility: Cuttingsville
state: Vermont
city: Hinesburg
country: United States
facility: Hinesburg
state: Vermont
city: Ludlow
country: United States
facility: Ludlow
state: Vermont
city: Rutland
country: United States
facility: Rutland
state: Vermont
city: Rutland
country: United States
facility: Rutland
state: Vermont
city: South Burlington
country: United States
facility: South Burlington
state: Vermont
city: Starksboro
country: United States
facility: Starksboro
state: Vermont
city: Starksboro
country: United States
facility: Starksboro
state: Vermont
city: Vergennes
country: United States
facility: Vergennes
state: Vermont
city: Winooski
country: United States
facility: Winooski
state: Vermont
city: La Conner
country: United States
facility: La Conner
state: Washington
city: Mount Vernon
country: United States
facility: Mount Vernon
state: Washington
city: Olympia
country: United States
facility: Olympia
state: Washington
city: Rochester
country: United States
facility: Rochester
state: Washington
city: Sedro-Woolley
country: United States
facility: Sedro Woolley
state: Washington
Study officials:
affiliation: Cornell University
name: Rebecca A. Seguin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Karla Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Jane Kolodinsky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Evergreen State College
name: Marilyn Sitaker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Alice Ammerman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Carolina University
name: Stephanie Jilcott-Pitts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.