Mobile Integrated Care for Childhood Obesity

Obesity Clinical Trial

Official title:

Mobile Integrated Care for Childhood Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936385
• Other study ID #: 416-Project
• Secondary ID: P20GM144270
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: December 2023
• Source: Nemours Children's Health System
• Contact: Thao-Ly T Phan, MD, MPH
• Phone: 302-331-7342
• Email: thaoly.phan[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 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.
• Standard of Care
Weight checks and lifestyle counseling with primary care provider every other month.

Locations

Country	Name	City	State
United States	Nemours Children's Health, Milford	Milford	Delaware
United States	Nemours Children's Health, Millsboro	Millsboro	Delaware
United States	Nemours Children's Health, Seaford	Seaford	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Health System	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	Visit adherence	Percentage of study visits attended and lost to follow-up (attrition) from study as documented in the electronic health record.	6 months
Secondary	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.	6 months
Secondary	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.	6 months