Health BehaviorNCT04109768
Hands On Nutrition Education to Improve Childhood Health
A study testing nutrition and activity in people with Health Behavior and Nutrition Poor, run by University of Alabama at Birmingham.
Trial summary
The main goals of this study is to better understand how an experiential cooking, movement and mindfulness intervention influence elementary school children at Spring Valley School. program diet, fitness, metabolic outcomes, health literacy and overall well-being. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Nutrition Poor
- What is being tested?
- nutrition and activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2020to 31 Mar 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- speak and read English able to ambulate student at selected school
Who cannot join
- medical condition precluding participation
About this study
Official title: Culinary Medicine Intervention to Empower Pre-Adolescent Children to Help Their Families to Improve Nutrition Literacy, Self-Image and Well-Being
The main goals of this study is to better understand how an experiential cooking, movement and mindfulness intervention influence elementary school children at Spring Valley School. program diet, fitness, metabolic outcomes, health literacy and overall well-being. Specifically, the role of the novel empowering experiential learning through a cooking and fitness intervention activities will play on health literacy and metabolic outcomes, engagement in fitness and motivation, and stress levels will be evaluated.
Read the detailed description
Nutrition and mindful movement program activities will take place during the school day. Children will be given the opportunity understand the value of quality nutrition in the prevention com-morbidities of treatment and poor lifestyle choices. The intervention will consist of ten sessions. This includes pre- and post-assessments (weeks 1 and 10) and eight weekly 1-hour interactive culinary medicine education sessions. Children will be asked questions about their diet, feelings, physical activity. Height, weight, waist circumference, and grip strength will also be measured. This will take about one hour prior to beginning the education portion of our program. Each week, \a nutrition lecture, a cooking demo and fitness activities will be completed over two-45 minutes sessions during PE class. These hands-on applied nutrition sessions include fundamental of nutrition, cooking skills, cooking skills, and activities. Experiential or hands-on applied learning, including culturally appropriate meal preparation and personalized nutrition and mindful movements, represents a potential tool to increase adolescent health literacy as well as empower adolescent to engage their families. Cooking as medicine helps people make the healthy behavior changes they are seeking because it allows hands-on teaching and learning in a fun interactive environment, without stigma. This strategy encompasses combination of thinking and doing skills that are applied during home food preparation, as well as conceptual and perceptual abilities on food handling, safety and storage, and other factors related to nutrition. The delivery of cooking as medicine programs serves as a way to improve and promote confidence, well-being, and enhance meal quality and preparation practices and offer a valuable platform to engage children and families via inclusive social activities, whilst positively impacting their dietary profiles and health outcomes.
- Conditions
- Health Behavior, Nutrition Poor
- Being tested
- nutrition and activity
- Medical subject headings
- Health Behavior, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition and activityBehavioural
16 sessions; nutrition 8; activity 8- 45 minutes to improve health and nutrition literacy
| Study group | Role | What they receive |
|---|---|---|
| Hands on Nutrition Education | Experimental | Nutrition and activity intervention to improve behaviors pre to post Receives: Behavioral: nutrition and activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
health literacy
A questionnaire to evaluate pre and post health literacy specific to nutrition will be used
Measured: 10 weeks
metabolic outcome
glucose, insulin, lipid profile will be evaluated by biochemical analysis following a blood draw
Measured: 10 weeks
self-efficacy
A self-efficacy questionnaire evaluating child's perceived capacity to prepare and consume healthy meals will be assessed.
Measured: 10-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start31 Mar 2020
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: PI left university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- pre post intervention
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Casazza, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109768
- Sponsor's protocol ID
- 300002498
- Status last verified
- Apr 2020
- First submitted
- 25 Sep 2019
- Last updated
- 30 Apr 2020
- 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 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culinary Medicine Intervention to Empower Pre-Adolescent Children to Help Their Families to Improve Nutrition Literacy, Self-Image and Well-Being
- ClinicalTrials.gov ID
- NCT04109768
- Acronym / sponsor ID
- 300002498
- Conditions
- Health Behavior, Nutrition Poor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 30 Sep 2019 (actual)
- 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 main goals of this study is to better understand how an experiential cooking, movement and mindfulness intervention influence elementary school children at Spring Valley School. program diet, fitness, metabolic outcomes, health literacy and overall well-being. Specifically, the role of the novel empowering experiential learning through a cooking and fitness intervention activities will play on health literacy and metabolic outcomes, engagement in fitness and motivation, and stress levels will be evaluated.
Detailed description
Nutrition and mindful movement program activities will take place during the school day. Children will be given the opportunity understand the value of quality nutrition in the prevention com-morbidities of treatment and poor lifestyle choices. The intervention will consist of ten sessions. This includes pre- and post-assessments (weeks 1 and 10) and eight weekly 1-hour interactive culinary medicine education sessions. Children will be asked questions about their diet, feelings, physical activity. Height, weight, waist circumference, and grip strength will also be measured. This will take about one hour prior to beginning the education portion of our program. Each week, \a nutrition lecture, a cooking demo and fitness activities will be completed over two-45 minutes sessions during PE class. These hands-on applied nutrition sessions include fundamental of nutrition, cooking skills, cooking skills, and activities. Experiential or hands-on applied learning, including culturally appropriate meal preparation and personalized nutrition and mindful movements, represents a potential tool to increase adolescent health literacy as well as empower adolescent to engage their families. Cooking as medicine helps people make the healthy behavior changes they are seeking because it allows hands-on teaching and learning in a fun interactive environment, without stigma. This strategy encompasses combination of thinking and doing skills that are applied during home food preparation, as well as conceptual and perceptual abilities on food handling, safety and storage, and other factors related to nutrition. The delivery of cooking as medicine programs serves as a way to improve and promote confidence, well-being, and enhance meal quality and preparation practices and offer a valuable platform to engage children and families via inclusive social activities, whilst positively impacting their dietary profiles and health outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre post intervention
| Arm | Type | Receives |
|---|---|---|
| Hands on Nutrition Education | Experimental | Behavioral: nutrition and activityNutrition and activity intervention to improve behaviors pre to post |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- speak and read English able to ambulate student at selected school
Key exclusion criteria (1 listed)
- medical condition precluding participation
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 |
|---|---|---|
| nutrition and activity16 sessions; nutrition 8; activity 8- 45 minutes to improve health and nutrition literacy | Behavioural | Hands on Nutrition Education |
Primary outcome
health literacy
Time frame: 10 weeks
A questionnaire to evaluate pre and post health literacy specific to nutrition will be used
metabolic outcome
Time frame: 10 weeks
glucose, insulin, lipid profile will be evaluated by biochemical analysis following a blood draw
self-efficacy
Time frame: 10-weeks
A self-efficacy questionnaire evaluating child's perceived capacity to prepare and consume healthy meals will be assessed.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition and activity in people with Health Behavior and Nutrition Poor, run by University of Alabama at Birmingham.
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 1 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: withdrawn, as of the sponsor's last update on 30 Apr 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
health literacy (time frame: 10 weeks). 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 30 Apr 2020.