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Healthy Kids Pilot

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT03297554
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
6.5
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: m-Health Intervention
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Healthy Kids Pilot
Actual Study Start Date :
Nov 13, 2017
Actual Primary Completion Date :
May 30, 2018
Actual Study Completion Date :
May 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: m-health approach

See intervention description

Behavioral: m-Health Intervention
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).

Outcome Measures

Primary Outcome Measures

  1. Acceptability/feasibility of the mHealth approach [Week 0 to Week 14-16]

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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

Sponsors and Collaborators

  • Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Amanda Staiano, PhD, Pennington Biomedical Research Center
  • Principal Investigator: Corby Martin, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amanda Staiano, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT03297554
Other Study ID Numbers:
  • 2017-044-PBRC
First Posted:
Sep 29, 2017
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Jan 18, 2022