Food ChoicesNCT02793024
Shopping Smart - Adolescent Intervention to Improve Shopping Practices Where You Live and Learn
A study testing Intervention in people with Food Choices, run by Alison Gustafson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Choices
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 18 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Food Choices
- Being tested
- Intervention
- Keywords
- food shopping intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention |
| Arm 2 - Intervention | No intervention | Control adolescents will not receive the intervention and will receive routine information normally distributed through schools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 12 weeks
Frequency of shopping at various food venues baseline and post intervention among intervention and control participants.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start12 Sep 2017
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food ChoicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alison Gustafson
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University
- Responsible party
- Sponsor-investigator, Alison Gustafson, University of Kentucky
- Investigators
- Alison Gustafson, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793024
- Sponsor's protocol ID
- 16-0114-PS
- Status last verified
- Feb 2018
- First submitted
- 27 May 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shopping Smart - Adolescent Intervention to Improve Shopping Practices Where You Live and Learn
- ClinicalTrials.gov ID
- NCT02793024
- Acronym / sponsor ID
- 16-0114-PS
- Conditions
- Food Choices
- Keywords
- food shopping intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Alison GustafsonUniversity, hospital or other
- Collaborators
- East Carolina University
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Intervention | Experimental | Behavioral: InterventionCounties 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. |
| Arm 2 - Intervention | No intervention | –Control adolescents will not receive the intervention and will receive routine information normally distributed through schools. |
Who may qualify
- Ages
- 14 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAdolescents 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. | Behavioural | Arm 1 - Intervention |
Primary outcome
Number of beverage choices per week at baseline and post intervention
Time frame: 12 weeks
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.
Number of fruit and vegetable servings per week among adolescents at baseline and post intervention
Time frame: 12 weeks
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.
2 secondary outcomes
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
Frequency of shopping at various food venues baseline and post intervention among intervention and control participants.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Gustafson, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Food Choices, run by Alison Gustafson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of beverage choices per week at baseline and post intervention (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.