Healthy Kids Pilot

Childhood Obesity Clinical Trial

Official title:

Healthy Kids Pilot

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03297554
• Other study ID #: PBRC 2017-044
• Status: Withdrawn
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: March 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

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).

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 202 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability/feasibility of the mHealth approach	Acceptability/feasibility of the mHealth approach will be evaluated by a survey on treatment satisfaction.	Week 0 to Week 14-16