NCT02996422

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,657

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

3.7 years

First QC Date

December 6, 2016

Last Update Submit

June 11, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 6 months, 12 months, 18 months, 24 months, 30 months

  • Change in fruit and vegetable consumption (adults)

    Survey items address frequency and quantity of consumption of fruits and vegetables in the past month.

    Baseline to 8 weeks

Secondary Outcomes (6)

  • Change in attitudes and preferences about beverages (students)

    Baseline, 6 months, 12 months, 18 months, 24 months, 30 months

  • Change in purchasing of drinks (students)

    Baseline, 6 months, 12 months, 18 months, 24 months, 30 months

  • Change in food preparation habits (adults)

    Baseline to 8 weeks

  • Change in food purchasing habits (adults)

    Baseline to 8 weeks

  • Change in perceptions of availability of health foods (adults)

    Baseline to 8 weeks

  • +1 more secondary outcomes

Study Arms (3)

School-based water campaign

EXPERIMENTAL

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.

Behavioral: School-based water campaign

Comparison schools

NO INTERVENTION

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.

Community cooking classes

EXPERIMENTAL

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.

Behavioral: Community cooking classes

Interventions

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.

School-based water campaign

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.

Community cooking classes

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding BehaviorDrinking Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Mark Swanson, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 19, 2016

Study Start

November 1, 2016

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share