Evaluating a Mindful Eating Curriculum, "Savor the Flavor"
1 other identifier
interventional
49
1 country
1
Brief Summary
The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 9, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJune 9, 2020
June 1, 2020
3 months
October 9, 2019
June 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Pre intervention and at conclusion of 5 week intervention
Secondary Outcomes (2)
Recall of Savor the Flavor steps
At conclusion of 5 week intervention
Acceptability of intervention
At conclusion of 5 week intervention
Other Outcomes (6)
Child body mass index
Measured once at any time between enrollment and conclusion of 5 week intervention
Child Eating Behavior Questionnaire
Measured once at any time between enrollment and conclusion of 5 week intervention
Structure and Control in Parent Feeding
Measured once at any time between enrollment and conclusion of 5 week intervention
- +3 more other outcomes
Study Arms (1)
Savor the Flavor
EXPERIMENTALThe "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.
Interventions
A series of five interactive classroom lessons focused on mindfulness in eating.
Eligibility Criteria
You may qualify if:
- Child must be enrolled in a Head Start preschool center
- Child must be between the ages of 2 and 6 years old
You may not qualify if:
- Food allergy or restriction to foods included in protocol
- Parent or other primary caregiver of a child enrolled in the study
- years of age or older
- English speaking
- \- None
- Actively employed as an early childhood education provider in the Head Start classroom where intervention is delivered
- years of age or older
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennsylvania State University
University Park, Pennsylvania, 16802, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer S Savage, PhD
Penn State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 9, 2019
First Posted
October 16, 2019
Study Start
October 1, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available after publication of primary outcomes.
- Access Criteria
- Access requests will be evaluated and approved at the principal investigator's discretion.
De-identified individual participant data will be available from the principal investigator upon request.