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Completed

NCT Number: NCT04127812

Evaluating a Mindful Eating Curriculum, "Savor the Flavor"

The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention.

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Key information

Conditions

Eating Behavior Behavior Behavior, Animal Body Weight Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Savor the Flavor

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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"

  2. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2019
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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