Family-Based Treatment for Childhood Type 1 Diabetes and Obesity (FBT for T1D Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University at Buffalo
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
How is Family-Based Treatment for T1D different from other treatments for childhood Type 1 Diabetes and obesity?
Family-Based Treatment for T1D is unique because it involves the whole family in the treatment process, focusing on nutrition, physical activity, and behavior changes. This approach is different from standard treatments that often focus solely on the individual child, and it leverages the support and involvement of family members to improve outcomes.
68101213What data supports the effectiveness of the treatment Family-Based Treatment for T1D in the clinical trial for childhood type 1 diabetes and obesity?
Research shows that family-based interventions can improve family relationships and communication, which are important for managing type 1 diabetes in children. Although the effects on treatment adherence and blood sugar control were not strong, these interventions can still support better overall health outcomes.
23479Will I have to stop taking my current medications?
The trial requires that participants stop taking medications that can affect weight, such as those for Attention Deficit Disorder or high-dose steroids for asthma.
Eligibility Criteria
This trial is for children aged 6-17 with Type 1 Diabetes (T1D) who are overweight/obese, use an insulin pump and continuous glucose monitoring device. They must have had T1D for at least a year and have one parent willing to join the program who is also overweight/obese. Excluded are those unable to do mild exercise, with certain chronic/autoimmune conditions or on weight-affecting meds.Inclusion Criteria
I have had Type 1 Diabetes for at least 12 months.
I am between 6 and 17 years old.
I am overweight or obese.
Exclusion Criteria
I cannot perform mild activities like walking.
Participant Groups
The study tests a Family-Based Treatment adapted for youth with T1D to address obesity in them and their parents. It aims to improve metabolic control in kids and tackle obesity-related issues in both generations through hybrid delivery of treatment that includes counseling.
1Treatment groups
Experimental Treatment
Group I: 20 Child-Parent DyadsExperimental Treatment1 Intervention
Family-Based Behavioral Treatment
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
ConventusBuffalo, NY
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Who is running the clinical trial?
University at BuffaloLead Sponsor
State University of New York at BuffaloLead Sponsor
National Center for Advancing Translational Sciences (NCATS)Collaborator
References
Family-based behavioural treatment of obesity: acceptability and effectiveness in the UK. [2016]To assess the acceptability and impact of family-based behavioural treatment (FBBT) for childhood obesity in a clinical setting in the UK.
Effects of behavioral family systems therapy for diabetes on adolescents' family relationships, treatment adherence, and metabolic control. [2022]Behavioral family systems therapy (BFST) for adolescents with diabetes has improved family relationships and communication, but effects on adherence and metabolic control were weak. We evaluated a revised intervention, BFST for diabetes (BFST-D).
The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. [2022]To identify modifiable family factors impacting glycemic control in youth with type 1 diabetes (T1DM) beyond the anticipated physical, developmental, and behavioral issues associated with adolescence.
Review of family-centered interventions to enhance the health outcomes of children with type 1 diabetes. [2018]The purpose of this systematic literature review was to examine family-centered interventions that enhance the health outcomes of children with type 1 diabetes. The review summarizes the interventions and outcome measures that consisted of A1Cs, family relationships, and family conflict.
Family-based treatment of severe pediatric obesity: randomized, controlled trial. [2022]We evaluated the efficacy of family-based, behavioral weight control in the management of severe pediatric obesity.
Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. [2022]The best outcomes for treating childhood obesity have come from comprehensive family-based programmes. However there are questions over their generalizability.
Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. [2022]To test the effect on diabetes management outcomes of a low-intensity, clinic-integrated behavioral intervention for families of youth with type 1 diabetes.
Current approaches to the management of pediatric overweight and obesity. [2021]Family-based behavioral intervention has been demonstrated to be an effective and safe treatment for childhood obesity and should be considered a first-line treatment option. However, access to such intensive evidence-based treatment is limited and, currently, obesity care is dominated by high intensity behavioral treatment implemented in specialty clinics or less effective low intensity treatments implemented in primary care. However, capitalizing on the established and ongoing relationship between primary care providers and families, primary care providers have an invaluable role in early identification of overweight and obesity, and subsequent referral to an evidence-based treatment. Key aspects of effective treatment include: early intervention, moderate intensity to high intensity intervention of sufficient duration, multicomponent intervention targeting dietary modification, physical activity and behavioral strategies, family involvement and goals targeting family members, and follow-up contact during maintenance. The purpose of this review is to present the current empirically supported treatment options for pediatric obesity including primary care-based interventions and diagnostic tools, multicomponent behavioral intervention with a focus on family-based behavioral intervention, immersion treatment, and pharmacologic and surgical management.
Family-Based Interventions Targeting Improvements in Health and Family Outcomes of Children and Adolescents with Type 1 Diabetes: a Systematic Review. [2019]A systematic review was conducted of family-based interventions to improve glycemic control, adherence, and psychosocial outcomes in children and adolescents with type 1 diabetes (T1D). Electronic databases were searched for randomized controlled trials (RCTs) published since the seminal Diabetes Control and Compliance Trial (DCCT). Interventions are summarized and findings reviewed to help guide clinical practice and future research.
Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. [2022]Family-based treatment (FBT) for children with overweight and obesity is a package that includes nutrition and physical activity education, as well as parenting and behavior therapy skills. To date, the majority of research suggests that one of the best predictors of child weight loss is parent weight loss. However, the bidirectional processes facilitating parent-child weight loss are not well understood.
Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. [2022]This study compares children with severe obesity and children with mild obesity/overweight participating in family-based obesity treatment (FBT) on change in (1) relative weight and adiposity and (2) psychosocial distress.
"I'm still here, but no one hears you": a qualitative study of young women's experiences of persistent distress post family-based treatment for adolescent anorexia nervosa. [2021]Family-based treatment (FBT) is the current treatment of choice for adolescent AN based on positive outcomes that include weight restoration in around two-thirds of adolescents. Nevertheless around a quarter drop-out from treatment, particularly in the earlier phases, and a notable proportion of treated adolescents are reported to experience ongoing psychological distress during and post-treatment. This study explores the under-researched experiences of these adolescents.
Relationships examined: Parent and child readiness to change and sociodemographic characteristics in family based weight loss treatment. [2023]Family based treatment is an effective, multipronged approach to address obesity as it plagues families.