- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04127812
Evaluating a Mindful Eating Curriculum, "Savor the Flavor"
June 5, 2020 updated by: Jennifer Savage Williams, Penn State University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Pennsylvania State University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Savor the Flavor
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.
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A series of five interactive classroom lessons focused on mindfulness in eating.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Pre intervention and at conclusion of 5 week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recall of Savor the Flavor steps
Time Frame: At conclusion of 5 week intervention
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Children will be asked to recall the five steps of "Savor the Flavor"
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At conclusion of 5 week intervention
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Acceptability of intervention
Time Frame: At conclusion of 5 week intervention
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Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention
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At conclusion of 5 week intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child body mass index
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
|
Child height and weight will be measured and used to calculate body mass index (BMI).
Age and sex specific BMI percentiles/z-scores will be calculated using CDC growth standards
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Child Eating Behavior Questionnaire
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the Child Eating Behavior Questionnaire as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Structure and Control in Parent Feeding
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the Structure and Control in Parent Feeding as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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USDA Food Security questionnaire
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the USDA food security questionnaire as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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External Food Responsiveness scale
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the External Food Responsiveness Scale as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Eating in the Absence of Hunger scale
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the Eating in the Absence of Hunger Scale as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer S Savage, PhD, Penn State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
October 9, 2019
First Submitted That Met QC Criteria
October 14, 2019
First Posted (Actual)
October 16, 2019
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 5, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00013064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data will be available from the principal investigator upon request.
IPD Sharing Time Frame
Data will be available after publication of primary outcomes.
IPD Sharing Access Criteria
Access requests will be evaluated and approved at the principal investigator's discretion.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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