20 Participants Needed

Family-Based Treatment for Childhood Type 1 Diabetes and Obesity

(FBT for T1D Trial)

TQ
AS
Overseen ByAndy Strohmeier, M.Ed.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University at Buffalo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Will 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.

Is family-based treatment generally safe for children?

Family-based treatment has been used for conditions like obesity and anorexia nervosa, and while it is generally considered safe, some participants may experience ongoing psychological distress during and after treatment.12345

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.12678

What 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.910111213

Are You a Good Fit for This Trial?

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.
You use a pump for insulin and a device to track your blood sugar levels.
I am between 6 and 17 years old.
See 2 more

Exclusion Criteria

The parent shows signs of depression according to the standard PHQ assessment.
The child has other autoimmune conditions besides type 1 diabetes or autoimmune thyroiditis.
I am a parent with a chronic condition treated with meds that affect weight loss or limit my physical activity.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Family-Based Behavioral Treatment with weekly coaching sessions for nine weeks, followed by bi-weekly sessions for two months, and then monthly sessions

26 weeks
7 in-person visits, 6 virtual visits

Follow-up

Participants are monitored for changes in weight, HbA1c, insulin dosing, and obesity co-morbidities

4 weeks

Extension

Potential continuation of monitoring and support for families showing significant progress

Optional

What Are the Treatments Tested in This Trial?

Interventions

  • Family-Based Treatment for T1D
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: 20 Child-Parent DyadsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University at Buffalo

Lead Sponsor

Trials
139
Recruited
105,000+

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Published Research Related to This Trial

The revised Behavioral Family Systems Therapy for diabetes (BFST-D) significantly improved family conflict and treatment adherence in adolescents with diabetes, particularly those with higher baseline HbA1c levels (≥ 9.0%).
Both BFST-D and an educational support group (ES) led to significant reductions in HbA1c compared to standard care, indicating that these interventions can effectively enhance metabolic control in adolescents with poor diabetes management.
Effects of behavioral family systems therapy for diabetes on adolescents' family relationships, treatment adherence, and metabolic control.Wysocki, T., Harris, MA., Buckloh, LM., et al.[2022]
Family-based interventions for children and adolescents with type 1 diabetes (T1D) have been shown to effectively improve glycemic control and psychosocial outcomes, based on a systematic review of 25 randomized controlled trials.
Most interventions involved both youth and their caregivers and were conducted in various settings, indicating a collaborative approach is beneficial; however, further research is needed to clarify the mechanisms behind these improvements and to explore additional health markers beyond HbA1c.
Family-Based Interventions Targeting Improvements in Health and Family Outcomes of Children and Adolescents with Type 1 Diabetes: a Systematic Review.Feldman, MA., Anderson, LM., Shapiro, JB., et al.[2019]
A 2-year randomized clinical trial involving 390 families showed that a low-intensity, clinic-integrated behavioral intervention significantly improved glycemic control in youth with type 1 diabetes, particularly in those aged 12 to 14.
The intervention effectively prevented the typical decline in diabetes management during adolescence, suggesting it could be a valuable approach to integrate behavioral support into medical care for diabetes.
Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial.Nansel, TR., Iannotti, RJ., Liu, A.[2022]

Citations

Effects of behavioral family systems therapy for diabetes on adolescents' family relationships, treatment adherence, and metabolic control. [2022]
Family-Based Interventions Targeting Improvements in Health and Family Outcomes of Children and Adolescents with Type 1 Diabetes: a Systematic Review. [2019]
Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. [2022]
Review of family-centered interventions to enhance the health outcomes of children with type 1 diabetes. [2018]
The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. [2022]
"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]
Relationships examined: Parent and child readiness to change and sociodemographic characteristics in family based weight loss treatment. [2023]
Family-based treatment of severe pediatric obesity: randomized, controlled trial. [2022]
Family-based behavioural treatment of obesity: acceptability and effectiveness in the UK. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. [2022]
Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Current approaches to the management of pediatric overweight and obesity. [2021]
Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. [2022]
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