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Mobile Integrated Care for Childhood Obesity

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Lifestyle
Standard of Care
Sponsored by
Nemours Children's Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Disparities, Stakeholder engagement, Social determinants of health, Healthcare delivery

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Caregiver and child dyads will be enrolled 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 rural neighborhood (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

Sites / Locations

  • Nemours Children's Health, MilfordRecruiting
  • Nemours Children's Health, MillsboroRecruiting
  • Nemours Children's Health, SeafordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthy Lifestyle

Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in child adiposity
Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Visit adherence
Percentage of study visits attended and lost to follow-up (attrition) from study as documented in the electronic health record.

Secondary Outcome Measures

Differences in change in child adiposity based on child sociodemographic characteristics
Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Differences in visit adherence based on child sociodemographic characteristics
Differences in percentage of study visits attended and lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.

Full Information

First Posted
June 20, 2023
Last Updated
August 16, 2023
Sponsor
Nemours Children's Health System
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05936385
Brief Title
Mobile Integrated Care for Childhood Obesity
Official Title
Mobile Integrated Care for Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Health System
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Disparities, Stakeholder engagement, Social determinants of health, Healthcare delivery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Lifestyle
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Weight checks and lifestyle counseling with primary care provider every other month.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle
Intervention Description
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
Intervention Name(s)
Standard of Care
Intervention Description
Weight checks and lifestyle counseling with primary care provider every other month.
Primary Outcome Measure Information:
Title
Change in child adiposity
Description
Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Time Frame
6 months
Title
Visit adherence
Description
Percentage of study visits attended and lost to follow-up (attrition) from study as documented in the electronic health record.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Differences in change in child adiposity based on child sociodemographic characteristics
Description
Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Time Frame
6 months
Title
Differences in visit adherence based on child sociodemographic characteristics
Description
Differences in percentage of study visits attended and lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Caregiver and child dyads will be enrolled 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 rural neighborhood (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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thao-Ly T Phan, MD, MPH
Phone
302-331-7342
Email
thaoly.phan@nemours.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thao-Ly T Phan, MD, MPH
Organizational Affiliation
Nemours Children's Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Health, Milford
City
Milford
State/Province
Delaware
ZIP/Postal Code
19963
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Bagas, MD
Facility Name
Nemours Children's Health, Millsboro
City
Millsboro
State/Province
Delaware
ZIP/Postal Code
19966
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry Lehman, MD
Facility Name
Nemours Children's Health, Seaford
City
Seaford
State/Province
Delaware
ZIP/Postal Code
19973
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiele Anthony, MD

12. IPD Sharing Statement

Learn more about this trial

Mobile Integrated Care for Childhood Obesity

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