Healthy Kids Pilot

NCT03297554 | Withdrawn

• 1 other identifier: PBRC 2017-044
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

m-health approach

EXPERIMENTAL

See intervention description

Behavioral: m-Health Intervention

Interventions

m-Health Intervention BEHAVIORAL

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).

m-health approach

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Have a smartphone
• Be willing to use the smartphone for the mHealth intervention

You may not qualify if:

• Significant cardiovascular disease or disorders via self-report from parent
• Other significant medical problems that would prevent them from engaging in regular physical activity.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related 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. 2021 Jan 7;4(1):e24714. doi: 10.2196/24714.

  PMID: 33410760 RESULT

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda Staiano, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Corby Martin, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 29, 2017
• Study Start: November 13, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)