Eating BehaviorNCT04127812
Evaluating a Mindful Eating Curriculum, "Savor the Flavor"
A study testing Savor the Flavor in people with Eating Behavior, run by Penn State University at 1 site in United States.
Trial summary
The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Savor the Flavor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Dec 2019
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Child Inclusion Criteria:
- Child must be enrolled in a Head Start preschool center
- Child must be between the ages of 2 and 6 years old
Child Exclusion Criteria:
- Food allergy or restriction to foods included in protocol
Parent Inclusion Criteria:
- Parent or other primary caregiver of a child enrolled in the study
- 18 years of age or older
- English speaking
Parent Exclusion Criteria:
- None
Teacher Inclusion Criteria:
- Actively employed as an early childhood education provider in the Head Start classroom where intervention is delivered
- 18 years of age or older
Teacher Exclusion Criteria:
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Evaluating a Mindful Eating Curriculum, "Savor the Flavor" to Promote Healthy Eating Among Head Start Preschool Children
The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention.
Read the detailed description
The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention. The goal of this curriculum is to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention will also teach children attention control techniques so that they are better able to delay consumption of high energy, low nutrition foods, when appropriate.The study will also evaluate a modified version of the Eating in the Absence of Hunger task for use in a preschool classroom setting.
- Conditions
- Eating Behavior
- Being tested
- Savor the Flavor
- Keywords
- mindfullness, eating, snacking, obesity, children
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savor the FlavorBehavioural
A series of five interactive classroom lessons focused on mindfulness in eating.
| Study group | Role | What they receive |
|---|---|---|
| Savor the Flavor | Experimental | The "Savor the Flavor" curriculum is a series of five interactive lessons designed to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention also teaches attention control techniques so that children are better able to delay consumption of high energy, low nutrition foods, when appropriate, as well as general mindfulness practices (e.g. breathing exercises). Lessons are delivered in the Head Start classroom by a nutrition educator. Receives: Behavioral: Savor the Flavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eating in the absence of hunger from pre to post intervention
Children will be given seven minutes of free access to a variety of palatable snacks and toys during a time when they are not hungry (e.g. after a meal). Intake of snacks is determined by pre and post weighing the foods.
Measured: Pre intervention and at conclusion of 5 week intervention
Secondary outcomes (2)
Recall of Savor the Flavor steps
Children will be asked to recall the five steps of "Savor the Flavor"
Measured: At conclusion of 5 week intervention
Acceptability of intervention
Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention
Measured: At conclusion of 5 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Selected classrooms will receive the Savor the Flavor intervention. Data will be collected prior to and after the intervention. Children, their parent/guardian, and classroom teachers will participate in the research.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Savage Williams, Penn State University
- Investigators
- Jennifer S Savage, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127812
- Sponsor's protocol ID
- STUDY00013064
- Status last verified
- Jun 2020
- First submitted
- 9 Oct 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available from the principal investigator upon request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Mindful Eating Curriculum, "Savor the Flavor" to Promote Healthy Eating Among Head Start Preschool Children
- ClinicalTrials.gov ID
- NCT04127812
- Acronym / sponsor ID
- STUDY00013064
- Conditions
- Eating Behavior
- Keywords
- mindfullness, eating, snacking, obesity, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Oct 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 overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention.
Detailed description
The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention. The goal of this curriculum is to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention will also teach children attention control techniques so that they are better able to delay consumption of high energy, low nutrition foods, when appropriate.The study will also evaluate a modified version of the Eating in the Absence of Hunger task for use in a preschool classroom setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Selected classrooms will receive the Savor the Flavor intervention. Data will be collected prior to and after the intervention. Children, their parent/guardian, and classroom teachers will participate in the research.
| Arm | Type | Receives |
|---|---|---|
| Savor the Flavor | Experimental | Behavioral: Savor the FlavorThe "Savor the Flavor" curriculum is a series of five interactive lessons designed to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention also teaches attention control techniques so that children are better able to delay consumption of high energy, low nutrition foods, when appropriate, as well as general mindfulness practices (e.g. breathing exercises). Lessons are delivered in the Head Start classroom by a nutrition educator. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Savor the FlavorA series of five interactive classroom lessons focused on mindfulness in eating. | Behavioural | Savor the Flavor |
Primary outcome
Change in eating in the absence of hunger from pre to post intervention
Time frame: Pre intervention and at conclusion of 5 week intervention
Children will be given seven minutes of free access to a variety of palatable snacks and toys during a time when they are not hungry (e.g. after a meal). Intake of snacks is determined by pre and post weighing the foods.
2 secondary outcomes
Recall of Savor the Flavor steps
Time frame: At conclusion of 5 week intervention
Acceptability of intervention
Time frame: At conclusion of 5 week intervention
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 9 Jun 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available from the principal investigator upon request.
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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.
Jennifer S Savage, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Savor the Flavor in people with Eating Behavior, run by Penn State University 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?
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 9 Jun 2020. 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 eating in the absence of hunger from pre to post intervention (time frame: Pre intervention and at conclusion of 5 week intervention). 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 9 Jun 2020.