NCT04127812

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

October 9, 2019

Last Update Submit

June 5, 2020

Conditions

Keywords

mindfullnesseatingsnackingobesitychildren

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

EXPERIMENTAL

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

Interventions

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

Savor the Flavor

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Feeding BehaviorObesity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer S Savage, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
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

De-identified individual participant data will be available from the principal investigator upon request.

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.

Locations