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

June 11, 2021 updated by: Mark Swanson, PhD

Appalachians Together Restoring the Eating Environment (Appal-TREE): Advancing Sustainable CBPR Interventions to Improve Healthy Diet in Rural Appalachian Children

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1657

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: School-based water campaign
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.
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.
No Intervention: Comparison schools
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.
Experimental: Community cooking classes
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in beverage consumption (students)
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
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.
Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Change in fruit and vegetable consumption (adults)
Time Frame: Baseline to 8 weeks
Survey items address frequency and quantity of consumption of fruits and vegetables in the past month.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in attitudes and preferences about beverages (students)
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Survey items address taste preferences, attitudes about eating/drinking behavior and body image, and self-efficacy.
Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Change in purchasing of drinks (students)
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Survey items will address frequency of purchasing beverages at fast food restaurants, convenience stores, and school venues and events.
Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Change in food preparation habits (adults)
Time Frame: Baseline to 8 weeks
Survey items address meal planning and preparation
Baseline to 8 weeks
Change in food purchasing habits (adults)
Time Frame: Baseline to 8 weeks
Survey items address frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
Baseline to 8 weeks
Change in perceptions of availability of health foods (adults)
Time Frame: Baseline to 8 weeks
Survey items address availability of high quality fruits and vegetables and low-fat foods
Baseline to 8 weeks
Change in barriers to health eating (adults)
Time Frame: Baseline to 8 weeks
Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark Swanson, PhD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0245-P3H
  • U01MD010556 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drinking Behavior

Clinical Trials on School-based water campaign

Subscribe