Healthy Kids I-PAL
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
m-health approach
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity
Eligibility Criteria
Inclusion Criteria for Child:
- Have at least one participating parent
- 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 smart phone
- 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
- Southeastern Louisiana University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
m-health approach
Arm Description
All dyads will receive the m-health approach.
Outcomes
Primary Outcome Measures
Acceptability/feasibility of the mHealth approach
Acceptability/feasibility of the mHealth approach will be evaluated by a survey.
Secondary Outcome Measures
Full Information
NCT ID
NCT03297541
First Posted
September 18, 2017
Last Updated
August 25, 2022
Sponsor
Pennington Biomedical Research Center
Collaborators
Southeastern Louisiana University
1. Study Identification
Unique Protocol Identification Number
NCT03297541
Brief Title
Healthy Kids I-PAL
Official Title
Healthy Kids at I-PAL (Interactive Physical Activity Lab)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Southeastern Louisiana University
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
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
m-health approach
Arm Type
Experimental
Arm Description
All dyads will receive the m-health approach.
Intervention Type
Behavioral
Intervention Name(s)
m-health approach
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.
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
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 smart phone
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
Southeastern Louisiana University
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70402
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33410760
Citation
Staiano AE, Shanley JR, Kihm H, Hawkins KR, Self-Brown S, Hochsmann C, Osborne MC, LeBlanc MM, Apolzan JW, Martin CK. Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. JMIR Pediatr Parent. 2021 Jan 7;4(1):e24714. doi: 10.2196/24714.
Results Reference
derived
Learn more about this trial
Healthy Kids I-PAL
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