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Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky

Primary Purpose

Feeding Behavior, Drinking Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
School-based water campaign
Community cooking classes
Sponsored by
Mark Swanson, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Feeding Behavior

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For school-based component: Student in selected middle or high school classroom in a participating school in intervention or comparison counties (6th to 12th grades)
  • For cooking classes: adult aged 18 years or older and residing in intervention county who have at least one dependent child attending middle or high school in the participating school districts

Exclusion Criteria:

  • Unable to speak or read English, as all materials will be presented in English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    No Intervention

    Experimental

    Arm Label

    School-based water campaign

    Comparison schools

    Community cooking classes

    Arm Description

    Students who attend middle and high schools in the intervention counties will receive a school-based water campaign. A sample of students from each school will complete surveys before and after the installation of the water refilling stations to measure beverage consumption, knowledge, attitudes, and self-efficacy.

    A sample of students who attend middle and high schools in the comparison county, which does not receive any intervention components, will complete surveys to measure beverage consumption, knowledge, attitudes, and self-efficacy.

    Adults in the same intervention counties as the school-based water campaign will enroll in group cooking classes. They will complete a baseline and two follow-up surveys to measure changes in fruit and vegetable consumption, attitudes, and self-efficacy.

    Outcomes

    Primary Outcome Measures

    Change in beverage consumption (students)
    Survey items address frequency and quantity of beverages consumed in past month. Includes water, pop/soda, diet pop/soda, sports drinks, energy drinks, sweetened tea, 100% fruit juice, and milk.
    Change in fruit and vegetable consumption (adults)
    Survey items address frequency and quantity of consumption of fruits and vegetables in the past month.

    Secondary Outcome Measures

    Change in attitudes and preferences about beverages (students)
    Survey items address taste preferences, attitudes about eating/drinking behavior and body image, and self-efficacy.
    Change in purchasing of drinks (students)
    Survey items will address frequency of purchasing beverages at fast food restaurants, convenience stores, and school venues and events.
    Change in food preparation habits (adults)
    Survey items address meal planning and preparation
    Change in food purchasing habits (adults)
    Survey items address frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
    Change in perceptions of availability of health foods (adults)
    Survey items address availability of high quality fruits and vegetables and low-fat foods
    Change in barriers to health eating (adults)
    Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating

    Full Information

    First Posted
    December 6, 2016
    Last Updated
    June 11, 2021
    Sponsor
    Mark Swanson, PhD
    Collaborators
    National Institute on Minority Health and Health Disparities (NIMHD), Community Farm Alliance
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02996422
    Brief Title
    Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky
    Official Title
    Appalachians Together Restoring the Eating Environment (Appal-TREE): Advancing Sustainable CBPR Interventions to Improve Healthy Diet in Rural Appalachian Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    July 31, 2020 (Actual)
    Study Completion Date
    July 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mark Swanson, PhD
    Collaborators
    National Institute on Minority Health and Health Disparities (NIMHD), Community Farm Alliance

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Most of the nation's serious chronic health challenges and causes of death, including diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both poor diets and associated disease are disproportionately common in the Appalachian counties of eastern Kentucky, a region with stark health inequities, including elevated rates of obesity, overweight, and premature mortality. The purpose of this study is to evaluate a multi-component intervention developed through community-based participatory research methods for improving access to healthy foods and enhancing dietary intake in eastern Kentucky. The intervention components evaluated in this study consist of: 1) a school-based campaign to promote water consumption in middle and high schools and 2) a series of group cooking classes for adults.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Feeding Behavior, Drinking Behavior

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1657 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    School-based water campaign
    Arm Type
    Experimental
    Arm Description
    Students who attend middle and high schools in the intervention counties will receive a school-based water campaign. A sample of students from each school will complete surveys before and after the installation of the water refilling stations to measure beverage consumption, knowledge, attitudes, and self-efficacy.
    Arm Title
    Comparison schools
    Arm Type
    No Intervention
    Arm Description
    A sample of students who attend middle and high schools in the comparison county, which does not receive any intervention components, will complete surveys to measure beverage consumption, knowledge, attitudes, and self-efficacy.
    Arm Title
    Community cooking classes
    Arm Type
    Experimental
    Arm Description
    Adults in the same intervention counties as the school-based water campaign will enroll in group cooking classes. They will complete a baseline and two follow-up surveys to measure changes in fruit and vegetable consumption, attitudes, and self-efficacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    School-based water campaign
    Intervention Description
    Includes: 1) the installation of filtered water bottle refilling stations, 2) the distribution of reusable water bottles to all students and teachers, and 3) a social marketing campaign to support the increase of water consumption among students.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Community cooking classes
    Intervention Description
    Cooking classes will be delivered to groups of 8-12 adult participants as a series of 8 weekly classes in community venues. The content of each class is driven by topics and themes identified and prioritized by community members, namely cooking healthy on tight budget.
    Primary Outcome Measure Information:
    Title
    Change in beverage consumption (students)
    Description
    Survey items address frequency and quantity of beverages consumed in past month. Includes water, pop/soda, diet pop/soda, sports drinks, energy drinks, sweetened tea, 100% fruit juice, and milk.
    Time Frame
    Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
    Title
    Change in fruit and vegetable consumption (adults)
    Description
    Survey items address frequency and quantity of consumption of fruits and vegetables in the past month.
    Time Frame
    Baseline to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Change in attitudes and preferences about beverages (students)
    Description
    Survey items address taste preferences, attitudes about eating/drinking behavior and body image, and self-efficacy.
    Time Frame
    Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
    Title
    Change in purchasing of drinks (students)
    Description
    Survey items will address frequency of purchasing beverages at fast food restaurants, convenience stores, and school venues and events.
    Time Frame
    Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
    Title
    Change in food preparation habits (adults)
    Description
    Survey items address meal planning and preparation
    Time Frame
    Baseline to 8 weeks
    Title
    Change in food purchasing habits (adults)
    Description
    Survey items address frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
    Time Frame
    Baseline to 8 weeks
    Title
    Change in perceptions of availability of health foods (adults)
    Description
    Survey items address availability of high quality fruits and vegetables and low-fat foods
    Time Frame
    Baseline to 8 weeks
    Title
    Change in barriers to health eating (adults)
    Description
    Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating
    Time Frame
    Baseline to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: For school-based component: Student in selected middle or high school classroom in a participating school in intervention or comparison counties (6th to 12th grades) For cooking classes: adult aged 18 years or older and residing in intervention county who have at least one dependent child attending middle or high school in the participating school districts Exclusion Criteria: Unable to speak or read English, as all materials will be presented in English
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Swanson, PhD
    Organizational Affiliation
    University of Kentucky
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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