- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399436
Appalachians Together Restoring the Eating Environment (Appal-TREE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: School-Based Healthy Snacking Campaign
Students who attend middle and high schools in the experimental county that participate in the healthy snacking campaign intervention.
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The school-based healthy snacking campaign includes the following activities:
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No Intervention: Comparison Schools
Students who attend middle and high schools in the comparison county, which does not receive any intervention components.
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Experimental: Community Cooking Classes
Adults in the intervention county who enroll in group cooking classes (single-group pretest-posttest)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beverage Consumption (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
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Frequency and quantity of beverages consumed in past month.
Includes water, 100% fruit juice, sugar-sweetened beverages, sugar-free beverages and milk.
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Baseline, 3 months, 6 months, and 14 months
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Change in Snack Consumption (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
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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.
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Baseline, 3 months, 6 months, and 14 months
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Change in Dietary intake (Adults)
Time Frame: Baseline to 8 weeks
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Frequency of consumption of fruits, vegetables, beans, candy, pastries, desserts, and salty snacks in the past month.
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Baseline to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Snacking Attitudes and Preferences (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
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Survey items address taste preferences, attitudes about healthy eating behaviors and body image
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Baseline, 3 months, 6 months, and 14 months
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Change in Healthy Snacking Confidence and Self-efficacy (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
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Baseline, 3 months, 6 months, and 14 months
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Change in Availability of Healthy Snack Foods (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
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Frequency of availability of healthy and unhealthy snack foods at school
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Baseline, 3 months, 6 months, and 14 months
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Change in Snack Food Purchasing Habits (Students)
Time Frame: Baseline, 3 months, 6 months, and 14 months
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Frequency of purchasing snack foods and beverages at fast food restaurants, convenience stores, and school venues and events
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Baseline, 3 months, 6 months, and 14 months
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Change in Food Preparation Habits (Adults)
Time Frame: Baseline to 8 weeks
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Likelihood of performing healthy food preparation behaviors; survey items address meal planning and preparation
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Baseline to 8 weeks
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Change in Food Purchasing Habits (Adults)
Time Frame: Baseline to 8 weeks
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Frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
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Baseline to 8 weeks
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Change in Perceptions of Availability of Healthy Foods (Adults)
Time Frame: Baseline to 8 weeks
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Survey items address availability of high quality fruits and vegetables and low-fat foods
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Baseline to 8 weeks
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Change in Barriers to Healthy Eating (Adults)
Time Frame: Baseline to 8 weeks
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Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating
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Baseline to 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12-0900-P3H
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.
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