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Healthy Kids Pilot

Primary Purpose

Childhood Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
m-Health Intervention
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

5 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Child:

  • Have at least one participating parent
  • Have a BMI percentile > 85
  • Be physically capable of exercise
  • Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer

Inclusion Criteria for Parent:

  • Have a smartphone
  • Be willing to use the smartphone for the mHealth intervention

Exclusion Criteria for Child:

  • Significant cardiovascular disease or disorders via self-report from parent
  • Other significant medical problems that would prevent them from engaging in regular physical activity.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

m-health approach

Arm Description

See intervention description

Outcomes

Primary Outcome Measures

Acceptability/feasibility of the mHealth approach
Acceptability/feasibility of the mHealth approach will be evaluated by a survey on treatment satisfaction.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2017
Last Updated
June 19, 2023
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03297554
Brief Title
Healthy Kids Pilot
Official Title
Healthy Kids Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study closed on May 30, 2018 and no participants were enrolled.
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
m-health approach
Arm Type
Experimental
Arm Description
See intervention description
Intervention Type
Behavioral
Intervention Name(s)
m-Health Intervention
Intervention Description
Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
Primary Outcome Measure Information:
Title
Acceptability/feasibility of the mHealth approach
Description
Acceptability/feasibility of the mHealth approach will be evaluated by a survey on treatment satisfaction.
Time Frame
Week 0 to Week 14-16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Child: Have at least one participating parent Have a BMI percentile > 85 Be physically capable of exercise Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer Inclusion Criteria for Parent: Have a smartphone Be willing to use the smartphone for the mHealth intervention Exclusion Criteria for Child: Significant cardiovascular disease or disorders via self-report from parent Other significant medical problems that would prevent them from engaging in regular physical activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Staiano, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Corby Martin, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Healthy Kids Pilot

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