NCT06658743

Brief Summary

The goal of this study is to learn about if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes. The main question\[s\] it aims to answer are:

  • Design four group activities centered around nutrition therapy, peer interactions, exercise and stress management.
  • Design the clinical workflow for implementation phase. Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

October 29, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

October 24, 2024

Last Update Submit

April 30, 2026

Conditions

Keywords

youth onset type 2 diabetesshared medical appointmentsgroup appointmentspediatric type 2 diabetes

Outcome Measures

Primary Outcomes (2)

  • Design four group activities for Team Clinic for youth with type 2 diabetes

    Activities will be prepared for the focus group for the following topics 1. Nutrition Therapy, 2. Peer Interactions, 3. Exercise, 4. Stress Management.

    Baseline to 5 months

  • Design Team Clinic for youth with type 2 diabetes workflow

    Team Clinic in a multidisciplinary care model that includes 1) individual encounter with clinician, 2) group activity, 3) caregiver group discussion, 4) option to consult with nurse, dietician, and/or behavioral health specialist.

    Baseline to 1 year

Study Arms (3)

Adolescents and Young Adult Advisory Council

Youth with type 2 diabetes between the ages of 12 to 18.

Care Giver Advisory Council

Care givers of youth with Type 2 diabetes.

Curriculum Reviewers

Multidisciplinary team members (including dieticians, clinicians, social workers, and nurses) that take care of patients with type 2 diabetes.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

AYA Advisory Council: Participants will include AYAT2D between the ages of 12 to 18. Caregiver Advisory Group: Participants will include caregivers of AYAT2D. The Stakeholder Advisory Board will include the PI, co-I's, study coordinator, group facilitators (including Certified Diabetes Care and Education Specialists \[CDCES\], RD, and behavioral health specialist \[BH: psychologist and social worker\]), clinicians, and clinic administrator. The Curriculum Reviewers will include CDCESs, nurses, nurse practitioners, dieticians, social workers or physicians in the diabetes clinic.

You may qualify if:

  • Age 12 to 18 at time of study enrollment
  • Receives care for type 2 diabetes
  • Willingness to attend all meetings
  • English-speaking

You may not qualify if:

  • Age 18 or above
  • Caregiver of AYA with type 2 diabetes
  • Willingness to attend all meetings
  • English- or Spanish-speaking
  • Non-verbal or unable to participate in group activities and discussions
  • Age 18 or above
  • On staff at CHLA or UCSF
  • Clinical or administrative member of the diabetes clinic
  • Willingness to participate in monthly meetings. If unable to attend, willingness to review meeting minutes.
  • Age 18 or above
  • CDCESs, nurses, nurse practitioners, dieticians, social workers or physicians in the diabetes clinic
  • Clinical members of the diabetes clinic
  • Member of the Stakeholder Advisory Board

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

UCSF

San Francisco, California, 94518, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lily Chao, MD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

October 29, 2024

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations