Healthy Kids Pilot

NCT ID: NCT03297554

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2018-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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m-health approach

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Group Type EXPERIMENTAL

m-Health Intervention

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Amanda Staiano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda Staiano, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Corby Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 33410760 (View on PubMed)

Other Identifiers

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PBRC 2017-044

Identifier Type: -

Identifier Source: org_study_id

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