Evaluating a Mindful Eating Curriculum, "Savor the Flavor"

Sponsor

Penn State University (Other)

Overall Status

Completed

CT.gov ID

NCT04127812

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

16.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Behavior	Behavioral: Savor the Flavor	N/A

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

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

Evaluating a Mindful Eating Curriculum, "Savor the Flavor" to Promote Healthy Eating Among Head Start Preschool Children

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

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.	Behavioral: Savor the Flavor A series of five interactive classroom lessons focused on mindfulness in eating.

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.

Behavioral: Savor the Flavor

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

Outcome Measures

Primary Outcome Measures

Change in eating in the absence of hunger from pre to post intervention [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.

Secondary Outcome Measures

Recall of Savor the Flavor steps [At conclusion of 5 week intervention]
Children will be asked to recall the five steps of "Savor the Flavor"
Acceptability of intervention [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

Other Outcome Measures

Child body mass index [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
Child Eating Behavior Questionnaire [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
Structure and Control in Parent Feeding [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
USDA Food Security questionnaire [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
External Food Responsiveness scale [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
Eating in the Absence of Hunger scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennsylvania State University	University Park	Pennsylvania	United States	16802

Sponsors and Collaborators

Penn State University

Investigators

Principal Investigator: Jennifer S Savage, PhD, Penn State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Savage Williams, Associate Professor, Penn State University

ClinicalTrials.gov Identifier:

NCT04127812

Other Study ID Numbers:

STUDY00013064

First Posted:

Oct 16, 2019

Last Update Posted:

Jun 9, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jennifer Savage Williams, Associate Professor, Penn State University

Study Results

No Results Posted as of Jun 9, 2020