Family-based treatment for managing Type 1 Diabetes and obesity
A Family-Based Approach to Treat Obesity and Its Co-morbidities in Youth With Type 1 Diabetes (T1D) and Their Parents
This study is testing a family-based program to help kids with Type 1 Diabetes and their parents manage weight and improve diabetes control together.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT05756361 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to improve obesity and metabolic control in youth aged 6-17 with Type 1 Diabetes (T1D) and their parents through a Family-Based Treatment (FBT) approach. The study will enroll 20 participants who have had T1D for over a year and are overweight or obese, along with at least one parent who also has overweight or obesity and related health issues. The intervention includes behavioral components, weight monitoring, and tailored support to address dietary habits and physical activity. The trial will last for 6 months and will utilize continuous glucose monitoring and insulin therapy to ensure optimal diabetes management.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-17 with Type 1 Diabetes for over a year, who are overweight or obese, and have a parent willing to participate who also has overweight or obesity.
Not a fit: Patients with chronic conditions other than Type 1 Diabetes, significant mental health issues, or disabilities that hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved weight management and metabolic control for both children with Type 1 Diabetes and their parents.
How similar studies have performed: While family-based interventions for obesity have shown promise in other contexts, this specific approach for Type 1 Diabetes and obesity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Buffalo, New York
- Conventus — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Teresa Quattrin, MD
- Email: tquattrin@upa.chob.edu
- Phone: (716) 480-3185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.