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

Status

Completed

Conditions

Intervention / Treatment

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

    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Pennsylvania State University

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.
A series of five interactive classroom lessons focused on mindfulness in eating.

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.
Pre intervention and at conclusion of 5 week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recall of Savor the Flavor steps
Time Frame: At conclusion of 5 week intervention
Children will be asked to recall the five steps of "Savor the Flavor"
At conclusion of 5 week intervention
Acceptability of intervention
Time Frame: At conclusion of 5 week intervention
Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention
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
Measured once at any time between enrollment and conclusion of 5 week intervention
Child Eating Behavior Questionnaire
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
Parents will complete the Child Eating Behavior Questionnaire as part of a survey packet
Measured once at any time between enrollment and conclusion of 5 week intervention
Structure and Control in Parent Feeding
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
Parents will complete the Structure and Control in Parent Feeding as part of a survey packet
Measured once at any time between enrollment and conclusion of 5 week intervention
USDA Food Security questionnaire
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
Parents will complete the USDA food security questionnaire as part of a survey packet
Measured once at any time between enrollment and conclusion of 5 week intervention
External Food Responsiveness scale
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
Parents will complete the External Food Responsiveness Scale as part of a survey packet
Measured once at any time between enrollment and conclusion of 5 week intervention
Eating in the Absence of Hunger scale
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
Parents will complete the Eating in the Absence of Hunger Scale as part of a survey packet
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.

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

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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