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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04127812
Other study ID # STUDY00013064
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date December 31, 2019

Study information

Verified date June 2020
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Pennsylvania State University University Park Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Child body mass index 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
Other Child Eating Behavior Questionnaire 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
Other Structure and Control in Parent Feeding 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
Other USDA Food Security questionnaire 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
Other External Food Responsiveness scale 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
Other Eating in the Absence of Hunger scale 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
Primary 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 Recall of Savor the Flavor steps Children will be asked to recall the five steps of "Savor the Flavor" At conclusion of 5 week intervention
Secondary Acceptability of 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
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