Appalachians Together Restoring the Eating Environment (Appal-TREE)

April 17, 2017 updated by: Mark Swanson, PhD
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 pilot 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 a social marketing campaign delivered to middle and high schools to promote healthy snacking and water consumption, and a series of group cooking classes for adults.

Study Overview

Detailed Description

This pilot study evaluates two principal components of a community-based intervention to improve dietary habits and access to healthy foods: a school-based healthy snacking campaign and a series of community cooking classes for adults. The primary outcome assessed within each intervention component is dietary intake as measured by self-reported beverage and food consumption in pre-post surveys. Secondary outcome variables include attitudes, preferences, confidence, self-efficacy and other psychosocial variables related to healthy eating behaviors, perceptions of healthy food availability, food purchasing and preparation habits, and perceived barriers to healthy eating.

The school-based intervention component employs a nonequivalent control group research design. A subset of middle- and high-schools within a single county in eastern KY will receive a healthy snacking campaign intervention, and students from randomly selected classrooms within these schools will be invited to enroll in the study. Students from middle- and high-school classrooms in a comparison county that receives no intervention will serve as nonequivalent controls. The investigators specific aims for this component are to improve the availability of healthy snack foods that students may purchase at school, increase student consumption of healthy snacks over unhealthy snacks, and increase the consumption of water over sugar-sweetened beverages. Following baseline, posttest surveys will be administered at 3, 6 and 14 months.

Community cooking classes will be delivered to a non-random sample of adults who will complete pretest-posttest measures at baseline and 8 weeks. The specific aims of this component are to increase the consumption of healthy foods at home, and increase participant knowledge, skills, and self-efficacy around healthy home cooking.

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For School-Based Component: 6th-12th grade students enrolled in a participating school and classroom in the intervention or comparison county.
  • For Cooking Classes: Adults aged 18 years and older residing in intervention county who have at least one juvenile in household.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: School-Based Healthy Snacking Campaign
Students who attend middle and high schools in the experimental county that participate in the healthy snacking campaign intervention.

The school-based healthy snacking campaign includes the following activities:

  • Sales promotion of snack choices that meet federal Smart Snack guidelines during the school day and at school events, such as snack bars and after-school events;
  • The installation of new filtered water fountains outfitted with water-filling stations;
  • The distribution of re-usable water bottles to students at participating schools; and
  • A social marketing campaign to support adoption of the healthy snacks and water consumption by students.
No Intervention: Comparison Schools
Students who attend middle and high schools in the comparison county, which does not receive any intervention components.
Experimental: Community Cooking Classes
Adults in the intervention county who enroll in group cooking classes (single-group pretest-posttest)
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, 3 months, 6 months, and 14 months
Frequency and quantity of beverages consumed in past month. Includes water, 100% fruit juice, sugar-sweetened beverages, sugar-free beverages and milk.
Baseline, 3 months, 6 months, and 14 months
Change in Snack Consumption (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
Frequency and quantity of snacks consumed in past month. Includes chips (regular and low-fat), salty snacks, candy, desserts, vegetables, fruit, nuts and seeds, vegetable dips, yogurt, and popcorn.
Baseline, 3 months, 6 months, and 14 months
Change in Dietary intake (Adults)
Time Frame: Baseline to 8 weeks
Frequency of consumption of fruits, vegetables, beans, candy, pastries, desserts, and salty snacks in the past month.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Snacking Attitudes and Preferences (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
Survey items address taste preferences, attitudes about healthy eating behaviors and body image
Baseline, 3 months, 6 months, and 14 months
Change in Healthy Snacking Confidence and Self-efficacy (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
Baseline, 3 months, 6 months, and 14 months
Change in Availability of Healthy Snack Foods (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
Frequency of availability of healthy and unhealthy snack foods at school
Baseline, 3 months, 6 months, and 14 months
Change in Snack Food Purchasing Habits (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
Frequency of purchasing snack foods and beverages at fast food restaurants, convenience stores, and school venues and events
Baseline, 3 months, 6 months, and 14 months
Change in Food Preparation Habits (Adults)
Time Frame: Baseline to 8 weeks
Likelihood of performing healthy food preparation behaviors; survey items address meal planning and preparation
Baseline to 8 weeks
Change in Food Purchasing Habits (Adults)
Time Frame: Baseline to 8 weeks
Frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
Baseline to 8 weeks
Change in Perceptions of Availability of Healthy 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 Healthy 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.

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

January 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

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.

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