Family-Based Treatment for Type 1 Diabetes

NCT05756361 | Active Not Recruiting

• 2 other identifiers: STUDY00006622: FBT for T1DUL1TR001412
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Weight for parent and child

  Participants will be given Body Trace Weight Scales and will weigh themselves twice per week.

  Baseline, 3 and 6 months

Secondary Outcomes (5)

• Change in insulin dosing

  baseline, 3 and 6 months

• In parents, change in severity of obesity co-morbidities

  baseline, 3 and 6 months

• Change in HbA1c

  baseline, 3 and 6 months

• Change in time in range (TIR) - that is in optimal glycemic range

  baseline, 3 and 6 months

• In parents, change in medication dosing

  baseline, 3 and 6 months

Study Arms (1)

20 Child-Parent Dyads

EXPERIMENTAL

Family-Based Behavioral Treatment

Behavioral: Family-Based Treatment for T1D

Interventions

Family-Based Treatment for T1D BEHAVIORAL

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

20 Child-Parent Dyads

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• T1D of 12 or more months duration
• Age 6-17-years
• Presence of overweight/obesity
• Youth uses a pump for insulin delivery and a continuous glucose monitoring device to monitor glycemic levels
• Youth has one parent with overweight/obesity willing to participate in the program

You may not qualify if:

• Child:
• Chronic conditions other than T1D
• Other autoimmune conditions other then T1D or autoimmune thyroiditis.
• Medications that can affects weight, such as medications used to treat Attention Deficit Disorder or high dose steroids used to treat asthma.
• Depression symptoms by standard of care Patient Health Questionnaire (PHQ) 9 in the child or parent
• Inability to perform at least mild physical activity such as walking
• Child with handicap (such as developmental delay or deafness) that would prevent him/her from benefitting from counseling in person and/or remotely Participating parent with
• symptoms of depression assessed by standard of care PHQ
• autoimmune disorders other than T1D or autoimmune thyroiditis
• Participating parents with chronic disorder that is treated with medications that interfere with weight loss or are preventing him/her from performing at least mild physical activity

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Conventus

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Pediatric Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Obesity; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 6, 2023
• Study Start: April 26, 2023
• Primary Completion: July 7, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)