Appalachians Together Restoring the Eating Environment

Dietary Habits Clinical Trial

— Appal-TREE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399436
• Other study ID #: 12-0900-P3H
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: April 17, 2017
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Habits

Intervention

Behavioral:
• School-Based Healthy Snacking Campaign
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.
• 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
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Mark Swanson, PhD	Community Farm Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in Snacking Attitudes and Preferences (Students)	Survey items address taste preferences, attitudes about healthy eating behaviors and body image	Baseline, 3 months, 6 months, and 14 months
Secondary	Change in Healthy Snacking Confidence and Self-efficacy (Students)		Baseline, 3 months, 6 months, and 14 months
Secondary	Change in Availability of Healthy Snack Foods (Students)	Frequency of availability of healthy and unhealthy snack foods at school	Baseline, 3 months, 6 months, and 14 months
Secondary	Change in Snack Food Purchasing Habits (Students)	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
Secondary	Change in Food Preparation Habits (Adults)	Likelihood of performing healthy food preparation behaviors; survey items address meal planning and preparation	Baseline to 8 weeks
Secondary	Change in Food Purchasing Habits (Adults)	Frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands	Baseline to 8 weeks
Secondary	Change in Perceptions of Availability of Healthy 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 Healthy Eating (Adults)	Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating	Baseline to 8 weeks