Dietary HabitsAppal-TREENCT02399436
Appalachians Together Restoring the Eating Environment
A study testing School-Based Healthy Snacking Campaign and Community Cooking Classes in people with Dietary Habits, run by Mark Swanson, PhD at 1 site in United States.
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?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- School-Based Healthy Snacking 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
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jul 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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 pilot 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 a social marketing campaign delivered to middle and high schools to promote healthy snacking and water consumption, and a series of group cooking classes for adults.
Read the 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.
- Conditions
- Dietary Habits
- Being tested
- School-Based Healthy Snacking Campaign, Community Cooking Classes
- Keywords
- Community-Based Participatory Research, Community-Institutional Relations
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-Based Healthy Snacking CampaignBehavioural
The school-based healthy snacking campaign includes the following activities:
- Sales promotion of snack choices that meet federal Smart Snack guidelines during the school day and at school events, such as snack bars and after-school events;
- The installation of new filtered water fountains outfitted with water-filling stations;
- The distribution of re-usable water bottles to students at participating schools; and
- A social marketing campaign to support adoption of the healthy snacks and water consumption by 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 Healthy Snacking Campaign | Experimental | Students who attend middle and high schools in the experimental county that participate in the healthy snacking campaign intervention. Receives: Behavioral: School-Based Healthy Snacking Campaign |
| Comparison Schools | No intervention | Students who attend middle and high schools in the comparison county, which does not receive any intervention components. |
| Community Cooking Classes | Experimental | Adults in the intervention county who enroll in group cooking classes (single-group pretest-posttest) 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)
Frequency and quantity of beverages consumed in past month. Includes water, 100% fruit juice, sugar-sweetened beverages, sugar-free beverages and milk.
Measured: Baseline, 3 months, 6 months, and 14 months
Change in Snack Consumption (Students)
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.
Measured: Baseline, 3 months, 6 months, and 14 months
Change in Dietary intake (Adults)
Frequency of consumption of fruits, vegetables, beans, candy, pastries, desserts, and salty snacks in the past month.
Measured: Baseline to 8 weeks
Secondary outcomes (8)
Change in Snacking Attitudes and Preferences (Students)
Survey items address taste preferences, attitudes about healthy eating behaviors and body image
Measured: Baseline, 3 months, 6 months, and 14 months
Change in Healthy Snacking Confidence and Self-efficacy (Students)
Measured: Baseline, 3 months, 6 months, and 14 months
Change in Availability of Healthy Snack Foods (Students)
Frequency of availability of healthy and unhealthy snack foods at school
Measured: Baseline, 3 months, 6 months, and 14 months
Change in Snack Food Purchasing Habits (Students)
Frequency of purchasing snack foods and beverages at fast food restaurants, convenience stores, and school venues and events
Measured: Baseline, 3 months, 6 months, and 14 months
Change in Food Preparation Habits (Adults)
Likelihood of performing healthy food preparation behaviors; survey items address meal planning and preparation
Measured: Baseline to 8 weeks
Change in Food Purchasing Habits (Adults)
Frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
Measured: Baseline to 8 weeks
Change in Perceptions of Availability of Healthy 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 Healthy 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 posted26 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Swanson, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Community Farm Alliance
- Responsible party
- Sponsor-investigator, Mark Swanson, PhD, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399436
- Sponsor's protocol ID
- 12-0900-P3H
- Acronym
- Appal-TREE
- Status last verified
- Apr 2017
- First submitted
- 12 Mar 2015
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appalachians Together Restoring the Eating Environment
- ClinicalTrials.gov ID
- NCT02399436
- Acronym / sponsor ID
- Appal-TREE / 12-0900-P3H
- Conditions
- Dietary Habits
- Keywords
- Community-Based Participatory Research, Community-Institutional Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Mark Swanson, PhDUniversity, hospital or other
- Collaborators
- Community Farm Alliance
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Mar 2015 (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 pilot 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 a social marketing campaign delivered to middle and high schools to promote healthy snacking and water consumption, and a series of group cooking classes for adults.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School-Based Healthy Snacking Campaign | Experimental | Behavioral: School-Based Healthy Snacking CampaignStudents who attend middle and high schools in the experimental county that participate in the healthy snacking campaign intervention. |
| Comparison Schools | No intervention | –Students who attend middle and high schools in the comparison county, which does not receive any intervention components. |
| Community Cooking Classes | Experimental | Behavioral: Community Cooking ClassesAdults in the intervention county who enroll in group cooking classes (single-group pretest-posttest) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| School-Based Healthy Snacking CampaignThe school-based healthy snacking campaign includes the following activities: * Sales promotion of snack choices that meet federal Smart Snack guidelines during the school day and at school events, such as snack bars and after-school events; * The installation of new filtered water fountains outfitted with water-filling stations; * The distribution of re-usable water bottles to students at participating schools; and * A social marketing campaign to support adoption of the healthy snacks and water consumption by students. | Behavioural | School-Based Healthy Snacking 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, 3 months, 6 months, and 14 months
Frequency and quantity of beverages consumed in past month. Includes water, 100% fruit juice, sugar-sweetened beverages, sugar-free beverages and milk.
Change in Snack Consumption (Students)
Time frame: Baseline, 3 months, 6 months, and 14 months
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.
Change in Dietary intake (Adults)
Time frame: Baseline to 8 weeks
Frequency of consumption of fruits, vegetables, beans, candy, pastries, desserts, and salty snacks in the past month.
8 secondary outcomes
Change in Snacking Attitudes and Preferences (Students)
Time frame: Baseline, 3 months, 6 months, and 14 months
Change in Healthy Snacking Confidence and Self-efficacy (Students)
Time frame: Baseline, 3 months, 6 months, and 14 months
Change in Availability of Healthy Snack Foods (Students)
Time frame: Baseline, 3 months, 6 months, and 14 months
Change in Snack Food Purchasing Habits (Students)
Time frame: Baseline, 3 months, 6 months, and 14 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 Healthy Foods (Adults)
Time frame: Baseline to 8 weeks
Change in Barriers to Healthy 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 19 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-Based Healthy Snacking Campaign and Community Cooking Classes in people with Dietary Habits, run by Mark Swanson, PhD 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 2 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 19 Apr 2017. 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?
Change in Beverage Consumption (Students) (time frame: Baseline, 3 months, 6 months, and 14 months). The study lists 3 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 19 Apr 2017.