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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02996422
Other study ID # 16-0245-P3H
Secondary ID U01MD010556
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date July 31, 2020

Study information

Verified date June 2021
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1657
Est. completion date July 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
School-based water campaign
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.
Community cooking classes
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Mark Swanson, PhD Community Farm Alliance, National Institute on Minority Health and Health Disparities (NIMHD)

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change in attitudes and preferences about beverages (students) 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
Secondary 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. Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Secondary Change in food preparation habits (adults) Survey items address meal planning and preparation Baseline to 8 weeks
Secondary Change in food purchasing habits (adults) Survey items address frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands Baseline to 8 weeks
Secondary Change in perceptions of availability of health foods (adults) Survey items address availability of high quality fruits and vegetables and low-fat foods Baseline to 8 weeks
Secondary Change in barriers to health eating (adults) Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating Baseline to 8 weeks
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