NCT02399436

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

March 12, 2015

Last Update Submit

April 17, 2017

Conditions

Keywords

Community-Based Participatory ResearchCommunity-Institutional Relations

Outcome Measures

Primary Outcomes (3)

  • Change in Beverage Consumption (Students)

    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)

    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)

    Frequency of consumption of fruits, vegetables, beans, candy, pastries, desserts, and salty snacks in the past month.

    Baseline to 8 weeks

Secondary Outcomes (8)

  • Change in Snacking Attitudes and Preferences (Students)

    Baseline, 3 months, 6 months, and 14 months

  • Change in Healthy Snacking Confidence and Self-efficacy (Students)

    Baseline, 3 months, 6 months, and 14 months

  • Change in Availability of Healthy Snack Foods (Students)

    Baseline, 3 months, 6 months, and 14 months

  • Change in Snack Food Purchasing Habits (Students)

    Baseline, 3 months, 6 months, and 14 months

  • Change in Food Preparation Habits (Adults)

    Baseline to 8 weeks

  • +3 more secondary outcomes

Study Arms (3)

School-Based Healthy Snacking Campaign

EXPERIMENTAL

Students who attend middle and high schools in the experimental county that participate in the healthy snacking campaign intervention.

Behavioral: School-Based Healthy Snacking Campaign

Comparison Schools

NO INTERVENTION

Students who attend middle and high schools in the comparison county, which does not receive any intervention components.

Community Cooking Classes

EXPERIMENTAL

Adults in the intervention county who enroll in group cooking classes (single-group pretest-posttest)

Behavioral: Community Cooking Classes

Interventions

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.

School-Based Healthy Snacking 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

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Department of Health Behavior, College of Public Health

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 26, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations