Feeding BehaviorNCT02996422
Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky
A study testing School-based water campaign and Community cooking classes in people with Feeding Behavior and Drinking Behavior, run by Mark Swanson, PhD.
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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior, Drinking Behavior
- What is being tested?
- School-based water campaign and Community cooking classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,657 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 31 Jul 2020
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For school-based component: Student in selected middle or high school classroom in a participating school in intervention or comparison counties (6th to 12th grades)
- For cooking classes: adult aged 18 years or older and residing in intervention county who have at least one dependent child attending middle or high school in the participating school districts
Who cannot join
- Unable to speak or read English, as all materials will be presented in English
About this study
Official title: Appalachians Together Restoring the Eating Environment (Appal-TREE): Advancing Sustainable CBPR Interventions to Improve Healthy Diet in Rural Appalachian Children
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 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: 1) a school-based campaign to promote water consumption in middle and high schools and 2) a series of group cooking classes for adults.
- Conditions
- Feeding Behavior, Drinking Behavior
- Being tested
- School-based water campaign, Community cooking classes
- Medical subject headings
- Feeding Behavior, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based water campaignBehavioural
Includes: 1) the installation of filtered water bottle refilling stations, 2) the distribution of reusable water bottles to all students and teachers, and 3) a social marketing campaign to support the increase of water consumption among students.
Community cooking classesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| School-based water campaign | Experimental | Students who attend middle and high schools in the intervention counties will receive a school-based water campaign. A sample of students from each school will complete surveys before and after the installation of the water refilling stations to measure beverage consumption, knowledge, attitudes, and self-efficacy. Receives: Behavioral: School-based water campaign |
| Comparison schools | No intervention | A sample of students who attend middle and high schools in the comparison county, which does not receive any intervention components, will complete surveys to measure beverage consumption, knowledge, attitudes, and self-efficacy. |
| Community cooking classes | Experimental | Adults in the same intervention counties as the school-based water campaign will enroll in group cooking classes. They will complete a baseline and two follow-up surveys to measure changes in fruit and vegetable consumption, attitudes, and self-efficacy. Receives: Behavioral: Community cooking classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beverage consumption (students)
Survey items address frequency and quantity of beverages consumed in past month. Includes water, pop/soda, diet pop/soda, sports drinks, energy drinks, sweetened tea, 100% fruit juice, and milk.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Change in fruit and vegetable consumption (adults)
Survey items address frequency and quantity of consumption of fruits and vegetables in the past month.
Measured: Baseline to 8 weeks
Secondary outcomes (6)
Change in attitudes and preferences about beverages (students)
Survey items address taste preferences, attitudes about eating/drinking behavior and body image, and self-efficacy.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Change in purchasing of drinks (students)
Survey items will address frequency of purchasing beverages at fast food restaurants, convenience stores, and school venues and events.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Change in food preparation habits (adults)
Survey items address meal planning and preparation
Measured: Baseline to 8 weeks
Change in food purchasing habits (adults)
Survey items address frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
Measured: Baseline to 8 weeks
Change in perceptions of availability of health foods (adults)
Survey items address availability of high quality fruits and vegetables and low-fat foods
Measured: Baseline to 8 weeks
Change in barriers to health eating (adults)
Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding BehaviorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Swanson, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Community Farm Alliance
- Responsible party
- Sponsor-investigator, Mark Swanson, PhD, University of Kentucky
- Investigators
- Mark Swanson, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996422
- Sponsor's protocol ID
- 16-0245-P3H
- Other IDs
- U01MD010556
- Status last verified
- Jun 2021
- First submitted
- 6 Dec 2016
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appalachians Together Restoring the Eating Environment (Appal-TREE): Advancing Sustainable CBPR Interventions to Improve Healthy Diet in Rural Appalachian Children
- ClinicalTrials.gov ID
- NCT02996422
- Acronym / sponsor ID
- 16-0245-P3H
- Conditions
- Feeding Behavior, Drinking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,657 participants (actual)
- Lead sponsor
- Mark Swanson, PhDUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Community Farm Alliance
- Study start
- Nov 2016
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 19 Dec 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.
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 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: 1) a school-based campaign to promote water consumption in middle and high schools and 2) a series of group cooking classes for adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School-based water campaign | Experimental | Behavioral: School-based water campaignStudents who attend middle and high schools in the intervention counties will receive a school-based water campaign. A sample of students from each school will complete surveys before and after the installation of the water refilling stations to measure beverage consumption, knowledge, attitudes, and self-efficacy. |
| Comparison schools | No intervention | –A sample of students who attend middle and high schools in the comparison county, which does not receive any intervention components, will complete surveys to measure beverage consumption, knowledge, attitudes, and self-efficacy. |
| Community cooking classes | Experimental | Behavioral: Community cooking classesAdults in the same intervention counties as the school-based water campaign will enroll in group cooking classes. They will complete a baseline and two follow-up surveys to measure changes in fruit and vegetable consumption, attitudes, and self-efficacy. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- For school-based component: Student in selected middle or high school classroom in a participating school in intervention or comparison counties (6th to 12th grades)
- For cooking classes: adult aged 18 years or older and residing in intervention county who have at least one dependent child attending middle or high school in the participating school districts
Key exclusion criteria (1 listed)
- Unable to speak or read English, as all materials will be presented in English
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 |
|---|---|---|
| School-based water campaignIncludes: 1) the installation of filtered water bottle refilling stations, 2) the distribution of reusable water bottles to all students and teachers, and 3) a social marketing campaign to support the increase of water consumption among students. | Behavioural | School-based water campaign |
| Community cooking classesCooking 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. | Behavioural | Community cooking classes |
Primary outcome
Change in beverage consumption (students)
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Survey items address frequency and quantity of beverages consumed in past month. Includes water, pop/soda, diet pop/soda, sports drinks, energy drinks, sweetened tea, 100% fruit juice, and milk.
Change in fruit and vegetable consumption (adults)
Time frame: Baseline to 8 weeks
Survey items address frequency and quantity of consumption of fruits and vegetables in the past month.
6 secondary outcomes
Change in attitudes and preferences about beverages (students)
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Change in purchasing of drinks (students)
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months
Change in food preparation habits (adults)
Time frame: Baseline to 8 weeks
Change in food purchasing habits (adults)
Time frame: Baseline to 8 weeks
Change in perceptions of availability of health foods (adults)
Time frame: Baseline to 8 weeks
Change in barriers to health eating (adults)
Time frame: Baseline to 8 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 16 Jun 2021.
- 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.
Mark Swanson, PhD principal investigator
University of Kentucky
Questions about this trial
What is this clinical trial studying?
A study testing School-based water campaign and Community cooking classes in people with Feeding Behavior and Drinking Behavior, run by Mark Swanson, PhD.
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 2 inclusion and 1 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in beverage consumption (students) (time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months). 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 16 Jun 2021.