Healthy Kids I-PAL

NCT03297541 | Completed Results

• 1 other identifier: PBRC 2016-009
• Study Type: interventional
• Target: 10
• 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)

• Child Acceptability of the mHealth Approach

  Children completed an acceptability survey at the end of the intervention that included Likert scales on intervention satisfaction. The items were average to calculate an average acceptability score. The scale range for the average total score is 1 to 5. A higher score indicates higher acceptability.

  13 Weeks

Secondary Outcomes (1)

• BMI Z-score Change

  Week 0 to Week 14-16

Study Arms (1)

m-health approach

EXPERIMENTAL

All dyads will receive the m-health approach.

Behavioral: m-health approach

Interventions

m-health approach 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). Anthropometric and demographic data collected on children in the dyad only.

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
• 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 smart phone
• 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
• Southeastern Louisiana University: collaborator

Study Sites (1)

Southeastern Louisiana University

Hammond, Louisiana, 70402, 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 DERIVED

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

Limitations and Caveats

A limitation of these studies is the one-arm design without a control or comparator and the need for further verification in a larger randomized controlled trial. It is possible that BMIz fluctuations were influenced by maturation bias or regression to the mean, though the observed effect size was similar to prior interventions. Another limitation is the use of BMIz to examine change, as researchers have identified concerns with z-score for children with a BMI above the 97th percentile.

Results Point of Contact

• Title: Dr. Amanda Staiano
• Organization: LSU's Pennington Biomedical Research Center

amanda.staiano@pbrc.edu

2257632500

Study Officials

• Amanda Staiano, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Corby Martin, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 5, 2017
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)