- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02793024
Shopping Smart - Adolescent Intervention to Improve Shopping Practices Where You Live and Learn
Study Overview
Detailed Description
Overview of the study - To achieve sustained healthy behavior changes, a supportive context is needed. For example, adolescents who are trying to consume more fruits and vegetables, fewer sugary beverages, and more water may be challenged in these pursuits as they may be inundated with low-cost, easily available, highly processed foods and beverages. The intervention will take into account the multiple sectors of influence on behavior among adolescents recently recommended. This project moves beyond understanding the interaction between the individual with their environment and seeks to develop and examine the effectiveness of an intervention aiming to improve how adolescents make healthy choices in a variety of food environments and in a variety of social settings.
Overview - This project includes collection of primary data in Year 1 to inform the curriculum development of the "Smart Shopping" intervention in Years 2 and 3. The intervention will take place among 4 schools (2 in KY and 2 in NC) with 4 delayed - control schools (2 in KY and 2 NC). This individual-level intervention will be tailored based on the food environment factors of each site. The key food environmental variables that will be addressed will be school policy adoption and implementation of School Wellness Policies, availability of food within the home, as well as the availability and access to various food venues in each county. After baseline data are collected, the curriculum will be developed reflecting the shopping behaviors of adolescents in these counties. The curriculum will utilize current Cooperative Extension resources from "Cooking Matters," but will be tailored and significantly revised for adolescents using the formative data collected in year 1. The curriculum will be developed with Cooperative Extension agents in each county while connecting with dietetics and nutrition students. The intervention will take place over 12 weeks, once a week, after school but before athletic or school sponsored activities begin. The intervention session will be led by nutrition and dietetics students, with oversight by Cooperative Extension agents and project team. Process evaluation will take place in year 2 and 3 of the study, while main intervention outcome evaluation will take place in year 4 led by project team.
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, 40514
- University of Kentucky
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- To be eligible for participation, the adolescent must provide assent and the primary caregiver must provide consent for their child to participate.
- The adolescents must have resided in the county for at least 1 year, plan to reside in the county for at least 1 year, speak English as the primary language, and not report any serious illness that would alter their dietary patterns, such as diabetes or Crohn's disease.
- If there is more than one adolescent in the household within the age range, the adolescent and the primary caregiver will decide which adolescent will participate in the project.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1 - Intervention
Counties will be randomized to receive the intervention or act as a delayed control.
Students in the intervention arm will receive the 12-week intervention to improve shopping choices.
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Adolescents in the intervention arm will receive 3 face to face session about making smart shopping choices.
The following 9 weeks will consist of utilizing social media to improve shopping choices.
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NO_INTERVENTION: Arm 2 - Intervention
Control adolescents will not receive the intervention and will receive routine information normally distributed through schools.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of beverage choices per week at baseline and post intervention
Time Frame: 12 weeks
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Beverage intake will be measured with the BEV-Q questionnaire at baseline to determine how many sugar-sweetened beverages and low calories are consumed over a 12 week period among intervention and control participants.
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12 weeks
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Number of fruit and vegetable servings per week among adolescents at baseline and post intervention
Time Frame: 12 weeks
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Fruit and vegetable serving intake will be measured with the National Cancer Institute Dietary Screener to determine how many servings of fruits and vegetables are consumed over a 12 week period among intervention and control participants.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Availability of fruits and vegetables, water, and sugar-sweetened beverages where adolescents live and shop at baseline and post intervention among intervention and control participants.
Time Frame: 12 weeks
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availability of fruits and vegetables, water, and SSB will be measured through a survey about availability in the home, school, and neighborhood food venues.
Questions from Youth Impact and Project EAT survey questions will capture availability.
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12 weeks
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Frequency of shopping at various food venues baseline and post intervention among intervention and control participants.
Time Frame: 12 weeks
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frequency of shopping at gas stations, convenience stores, and fast-food restaurants compared to controls, as measured by self-report shopping behavior patterns survey7 and key questions from the Youth Impact Questionnaire
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12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alison Gustafson, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start (ACTUAL)
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
Keywords
Other Study ID Numbers
- 16-0114-PS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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