NCT04109768

Brief Summary

The main goals of this study is to better understand how an experiential cooking, movement and mindfulness intervention influence elementary school children at Spring Valley School. program diet, fitness, metabolic outcomes, health literacy and overall well-being. Specifically, the role of the novel empowering experiential learning through a cooking and fitness intervention activities will play on health literacy and metabolic outcomes, engagement in fitness and motivation, and stress levels will be evaluated.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

March 31, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

September 25, 2019

Last Update Submit

April 28, 2020

Conditions

Health BehaviorNutrition Poor

Outcome Measures

Primary Outcomes (3)

  • health literacy

    A questionnaire to evaluate pre and post health literacy specific to nutrition will be used

    10 weeks

  • metabolic outcome

    glucose, insulin, lipid profile will be evaluated by biochemical analysis following a blood draw

    10 weeks

  • self-efficacy

    A self-efficacy questionnaire evaluating child's perceived capacity to prepare and consume healthy meals will be assessed.

    10-weeks

Study Arms (1)

Hands on Nutrition Education

EXPERIMENTAL

Nutrition and activity intervention to improve behaviors pre to post

Behavioral: nutrition and activity

Interventions

nutrition and activityBEHAVIORAL

16 sessions; nutrition 8; activity 8- 45 minutes to improve health and nutrition literacy

Hands on Nutrition Education

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • speak and read English able to ambulate student at selected school

You may not qualify if:

  • medical condition precluding participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health BehaviorMalnutrition

Interventions

Nutritional StatusExercise

Condition Hierarchy (Ancestors)

BehaviorNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: pre post intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 30, 2019

Study Start

March 31, 2020

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 30, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share