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Family-Based Treatment for Type 1 Diabetes

NCT05756361 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-16

No results posted yet for this study

Summary

Type 1 Diabetes carries high burden for affected youth and their families. Advances in insulin therapy and technology have been associated with increased obesity with 1/3 adolescents being overweight/obese. Since obesity runs in families and carries risk for poor outcomes psychologically and medically, the investigators are adapting our successful evidence-based Family Based Treatment for hybrid delivery to improve obesity and metabolic control in the affected youth and improve obesity and related co-morbidities in their parents.

Conditions

  • Diabetes Mellitus, Type 1
  • Obesity, Childhood
  • Overweight
  • Comorbidities and Coexisting Conditions

Interventions

BEHAVIORAL

Family-Based Treatment for T1D

Our FBT curriculum, which has been delivered successfully in the specialty and primary care settings, has 3 components: 1. Meal planning including quality of carbohydrates and glycemic index for both parents and children while ensuring that youth have a balanced meal plan with adequate amounts of carbohydrates for optimal growth. Our FBT has a focus on "Food Literacy" including healthy food selection and sourcing of affordable healthy food, food preparation and preplanning, social engagement tailoring the meal plan to the needs to the family in socio cultural appropriate way and also feasibility based on logistics and economic aspects; 2. Physical activity (PA) component with shaping strategy to allow for a progressive shaping of easy PA starting, if needed, with as little as with 10 minutes of walking/day and strategies to incorporate PA in daily routines, family, and social activities; 3. Extensive behavioral component which has been shown to be very powerful in obesity treatment

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • State University of New York at Buffalo

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2025-07-07
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05756361 on ClinicalTrials.gov