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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

  • 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 ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up ]
    Data coll

    Original Primary Outcome:

    • 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 ]
      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 [ Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up ]
      Data collected with non-consecutive 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 [ Time Frame: 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 [ Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up ]
      Data collected with non-consecutive 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 [ Time Frame: Baseline to 4 months, 16-month follow-up, and 28-month follow-up ]

      Current Secondary Outcome:

      • Change in child's BMI percentile [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


      Original Secondary Outcome: Same as current

      Information By: Cornell University

      Dates:
      Date Received: April 5, 2016
      Date Started: April 2015
      Date Completion: December 2018
      Last Updated: March 22, 2017
      Last Verified: March 2017