- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02996422
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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
-
Penn State UniversityNot yet recruiting
-
Penn State UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institutes...TerminatedUnderage Drinking | Driving Under the Influence | Drinking, Teen | Drinking, CollegeUnited States
-
Auburn UniversityNot yet recruiting
-
Yonsei UniversityBlueSignum CorporationRecruitingAlcohol Drinking | High-Risk Drinking PatternsSouth Korea
-
Brown UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruitingAlcohol Drinking | Youth DrinkingUnited States
-
University of MiamiExegi PharmaRecruiting
-
The Hong Kong Polytechnic UniversityNot yet recruitingHazardous Drinking | Harmful Alcohol Use
-
University of WyomingRecruitingAlcohol Drinking | CravingUnited States
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedDrinking Behavior | Adolescent Behavior | Drinking, Alcohol | Alcohol Drinking, AdolescentUnited States
-
State University of New York at BuffaloNot yet recruitingSexual Violence | College Drinking | Behavioral ChangesUnited States
Clinical Trials on School-based water campaign
-
Mark Swanson, PhDCommunity Farm AllianceCompleted
-
University of BaghdadNot yet recruiting
-
Centers for Disease Control and PreventionProcter and Gamble; Centers for Disease Control and Prevention, China; Zhejiang... and other collaboratorsCompletedInfectious Disease | Absenteeism | Respiratory IllnessChina, Pakistan, Philippines
-
University of GuamNational Cancer Institute (NCI); University of Hawaii Cancer Research CenterCompletedTobacco Smoking | Vaping | Tobacco ChewingGuam
-
University of RochesterNational Heart, Lung, and Blood Institute (NHLBI); Halcyon Hill FoundationCompleted
-
Nordic Institute for Studies of Innovation, Research...University of Agder; The Institute of Transport Economics, Norway; Fredrikstad... and other collaboratorsRecruitingPhysical Inactivity | Health LiteracyNorway
-
Canisius CollegeU.S. Department of EducationCompleted
-
Hong Kong Baptist UniversityNot yet recruitingSleep | Physical Activities | Sedentary Behaviors | Fundamental Movement SkillsBangladesh
-
Universiti Putra MalaysiaUniversity of LahoreNot yet recruitingObesity, Childhood | Child Behavior | Child ObesityPakistan
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain