- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03297554
Healthy Kids Pilot
March 27, 2024 updated by: Amanda Staiano, Pennington Biomedical Research Center
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: m-health approach
See 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability/feasibility of the mHealth approach
Time Frame: Week 0 to Week 14-16
|
Acceptability/feasibility of the mHealth approach will be evaluated by a survey on treatment satisfaction.
|
Week 0 to Week 14-16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Corby Martin, PhD, Pennington Biomedical Research Center
- Principal Investigator: Amanda Staiano, PhD, Pennington Biomedical Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2017
Primary Completion (Actual)
May 30, 2018
Study Completion (Actual)
May 30, 2018
Study Registration Dates
First Submitted
September 18, 2017
First Submitted That Met QC Criteria
September 26, 2017
First Posted (Actual)
September 29, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2017-044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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