NCT02793024

Brief Summary

The objective of this project is to develop and test the effectiveness of a Cooperative Extension enhanced intervention titled "Smart Shopping," aimed at improving the shopping practices of adolescents with the ultimate goal of increasing fruit and vegetable intake. To achieve this goal, the investigators will conduct formative research (Year 1) via a community-wide analysis of the school, home and neighborhood food environments. In collaboration with Extension staff and faculty, this formative research will provide insight into the development and enhancement of the "Smart Shopping" curriculum (adapted from the "Cooking Matters" Extension curriculum, Year 2). In Years 3-4, the investigators will implement a randomized controlled intervention trial to examine the effectiveness of the developed intervention "Smart Shopping" to improve adolescents' purchasing and consumption behaviors. The investigators will implement the trial in Year 3, and evaluate results in Year 4. Our education component will include training of University dietetics interns, graduate, and undergraduate students to implement and evaluate the intervention with oversight by project staff as part of their service learning requirements. This project is unique as it: 1) takes into account the role that school wellness policies and school environment have in food procurement during the day; 2) incorporates information from multiple levels of the social ecological framework (home, school, and community food environments, as well as the social influence of peers) to create an intervention that addresses influences on adolescents purchasing and consumption behaviors where they live and learn; 3) collaborates with Extension faculty and staff while enhancing an existing program; 4) utilizes and hones the skill sets of students in undergraduate and graduate level nutrition and dietetics programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

May 27, 2016

Last Update Submit

February 5, 2018

Conditions

Keywords

food shopping intervention

Outcome Measures

Primary Outcomes (2)

  • Number of beverage choices per week at baseline and post intervention

    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.

    12 weeks

  • Number of fruit and vegetable servings per week among adolescents at baseline and post intervention

    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.

    12 weeks

Secondary Outcomes (2)

  • 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.

    12 weeks

  • Frequency of shopping at various food venues baseline and post intervention among intervention and control participants.

    12 weeks

Study Arms (2)

Arm 1 - Intervention

EXPERIMENTAL

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.

Behavioral: Intervention

Arm 2 - Intervention

NO INTERVENTION

Control adolescents will not receive the intervention and will receive routine information normally distributed through schools.

Interventions

InterventionBEHAVIORAL

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.

Arm 1 - Intervention

Eligibility Criteria

Age14 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40514, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Alison Gustafson, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor/Investigator

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 8, 2016

Study Start

September 12, 2017

Primary Completion

December 18, 2017

Study Completion

December 18, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations