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Healthy Kids I-PAL

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ClinicalTrials.gov Identifier: NCT03297541
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
Southeastern Louisiana University
Information provided by (Responsible Party):
Amanda Staiano, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: m-health approach Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healthy Kids at I-PAL (Interactive Physical Activity Lab)
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : December 12, 2017
Actual Study Completion Date : December 12, 2017

Arm Intervention/treatment
Experimental: m-health approach
All dyads will receive the m-health approach.
Behavioral: m-health approach
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 Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297541


Locations
United States, Louisiana
Southeastern Louisiana University
Hammond, Louisiana, United States, 70402
Sponsors and Collaborators
Pennington Biomedical Research Center
Southeastern Louisiana University
Investigators
Principal Investigator: Amanda Staiano, PhD Pennington Biomedical Research Center
Principal Investigator: Corby Martin, PhD Pennington Biomedical Research Center

Responsible Party: Amanda Staiano, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03297541     History of Changes
Other Study ID Numbers: 2016-009-PBRC
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms