Mobile Integrated Care for Childhood Obesity

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2025-06-01

Brief Summary

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The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.

Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months.

The other group will be in our Healthy Lifestyle program for 6 months. This will include:

* Check-ins with lifestyle specialists and community health workers,
* A mobile app to help support a healthy lifestyle, and
* Access to community programs and activities.

The main questions the study aims to answer are:

* Do children in the Healthy Lifestyle program have better weight outcomes?
* Do more families in the Healthy Lifestyle program stay in the study?
* Does the Healthy Lifestyle program work better for families from certain communities?

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Healthy Lifestyle

Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.

Group Type EXPERIMENTAL

Healthy Lifestyle

Intervention Type BEHAVIORAL

Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.

Standard of Care

Weight checks and lifestyle counseling with primary care provider every other month.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type BEHAVIORAL

Weight checks and lifestyle counseling with primary care provider every other month.

Interventions

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Healthy Lifestyle

Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.

Intervention Type BEHAVIORAL

Standard of Care

Weight checks and lifestyle counseling with primary care provider every other month.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Child 4-12 years of age
* Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro
* Child has a BMI ≥ 95% for age and sex
* Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)

Exclusion Criteria

* Caregiver not child's legal guardian
* Caregiver not proficient in English or Spanish
* Caregiver does not have a device and reliable internet
* Child has a genetic syndrome or endocrine disorder that predisposes to obesity
* Child is on a medication that impacts weight
* Child is already enrolled in a weight management program

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes