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NCT05756361
Family-Based Treatment for Type 1 Diabetes
Conditions: Diabetes Mellitus, Type 1, Obesity, Childhood, Overweight, Comorbidities and Coexisting Conditions
Sex: All
Ages: 6 Years – 17 Years
Phase: NA
Enrollment: 20
Sponsor: University at Buffalo
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.
Eligibility Criteria
Inclusion Criteria:T1D of 12 or more months durationAge 6-17-yearsPresence of overweight/obesityYouth uses a pump for insulin delivery and a continuous glucose monitoring device to monitor glycemic levelsYouth has one parent with overweight/obesity willing to participate in the programExclusion Criteria:Child:Chronic conditions other than T1DOther 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 parentInability to perform at least mild physical activity such as walkingChild with handicap (such as developmental delay or deafness) that would prevent him/her from benefitting from counseling in person and/or remotely Participating parent withsymptoms of depression assessed by standard of care PHQautoimmune disorders other than T1D or autoimmune thyroiditisParticipating 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
Source: ClinicalTrials.gov (NCT05756361). StuddyBuddy aggregates publicly available trial information.