NCT02767830

Brief Summary

A 12 month long program focused on making good food choices and exercise directed at 8-12 year olds and their caregivers. The program will consist of monthly educational meetings each teaching a new nutritional and exercise concept. Children will be given weekly exercise schedules and their adherence to the program will be assessed. The study will culminate with an annual children's race in May.

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 Sep 2016

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withdrawn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

May 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

May 8, 2016

Last Update Submit

May 2, 2022

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

  • Adherence to program

    number of subjects who participate in race

    12 months

Study Arms (1)

Excercise and Nutrition Program

EXPERIMENTAL

Children and their care givers will receive 5 lectures on nutrition and exercise and will be given a weekly running program. At the end of the study children will be encouraged to participate in an annual 0.25-0.5 mile race.

Behavioral: Excercise and Nutrition Program

Interventions

Excercise and Nutrition ProgramBEHAVIORAL
Excercise and Nutrition Program

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants must be aged 8-12 years old and enrolled in kindergarten through 6th grade in a Cleveland Public School
  • Participants must have at least a B-average or equivalent in the prior academic year
  • Participants must have at least one part or guardian who is able to accompany the participant during exercise and educational sessions
  • Participants must be willing to participate in the Rite Aid Cleveland Marathon Ringling Bros. and Barnum \& Bailey Red Nose Run® at the end of the study

You may not qualify if:

  • Children who are younger than 8 years or older than 12 years
  • Children whose parents who are unable or unwilling to provide informed consent,
  • Children whose parents are are illiterate or non-English speaking or reading
  • Children whose parents are unable or unwilling to accompany them to educational and exercise sessions
  • Children with a medical condition that prevents them from unmonitored exercise
  • Children who have not maintained an equivalent of a B-average in the prior academic year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2016

First Posted

May 10, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

May 6, 2022

Record last verified: 2022-05