Family-Based Treatment for Childhood Type 1 Diabetes and Obesity

(FBT for T1D Trial)

Overseen By Andy Strohmeier, M.Ed.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University at Buffalo

Must not be taking: ADD meds, High-dose steroids

Disqualifiers: Chronic conditions, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance obesity management and metabolic control in children with Type 1 Diabetes (T1D) and their parents. It employs a Family-Based Treatment approach, involving both the child with T1D and an overweight or obese parent. The primary goal is to help families adopt healthier habits, leading to improved physical and mental health outcomes. Children aged 6-17 with T1D for at least a year, who use an insulin pump and glucose monitoring device, and have a participating parent with obesity, are suitable candidates for this trial. As an unphased trial, it offers families the chance to contribute to innovative research that could improve their health and well-being.

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.

What prior data suggests that this Family-Based Treatment is safe for children with Type 1 Diabetes and obesity?

Research has shown that family-based treatment for issues like obesity and eating disorders is generally safe. Participants in past studies report that this type of treatment is manageable. While some might experience minor problems, serious side effects are uncommon.

For instance, family-based treatment has been used successfully for various health issues without major safety concerns. This includes addressing obesity, a primary focus of the treatment under study for children with Type 1 Diabetes. Safety data from similar methods suggest that families can participate with confidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for childhood Type 1 Diabetes, which typically focuses on insulin management and dietary changes, the Family-Based Treatment for T1D takes a holistic approach. Researchers are excited about this method because it involves a family-based behavioral treatment, engaging both parents and children to work together on managing the condition and addressing obesity. This approach has the potential to improve adherence to treatment plans and foster a supportive environment, which could lead to better long-term health outcomes for children.

What evidence suggests that this Family-Based Treatment is effective for improving obesity and metabolic control in youth with Type 1 Diabetes?

Research has shown that family-based treatments can effectively manage childhood obesity, which is crucial for children with Type 1 Diabetes. In one study, children in these programs reduced their excess weight by 7.58% within six months. Another review found success rates between 43% and 73% in managing weight. Additionally, a study found that children receiving family-based treatment had better weight outcomes than those receiving usual care over 24 months. This trial will involve 20 child-parent dyads receiving family-based behavioral treatment. These programs often include parents, leading to a greater reduction in childhood overweight. Overall, family-based methods show promise for improving weight and related health outcomes in affected children. ^{5 6 7 8 9}

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.

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.

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?

Group I: 20 Child-Parent Dyads Experimental Treatment 1 Intervention

Family-Based Behavioral Treatment

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

Family-based treatment (FBT) is effective for weight restoration in about two-thirds of adolescents with anorexia nervosa (AN), but many still experience psychological distress during and after treatment, highlighting the need for a more holistic approach.

Participants emphasized the importance of family involvement in their recovery but felt that the initial focus on weight restoration often neglected their psychological needs, suggesting that treatment should prioritize their voices and unique experiences for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"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. Conti, J., Joyce, C., Natoli, S., et al.[2021]

A family-based behavioral weight control intervention for 192 children aged 8 to 12 resulted in a significant 7.58% decrease in percent overweight at 6 months, compared to only 0.66% in the usual care group.

Children who attended at least 75% of the intervention sessions were able to maintain their weight loss benefits over 18 months, highlighting the importance of consistent participation in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based treatment of severe pediatric obesity: randomized, controlled trial. Kalarchian, MA., Levine, MD., Arslanian, SA., et al.[2022]

Family-based behavioral interventions are effective and safe for treating childhood obesity and should be prioritized as a first-line treatment option.

Primary care providers play a crucial role in identifying childhood obesity early and referring families to evidence-based treatments, emphasizing the importance of comprehensive, family-involved strategies for successful long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current approaches to the management of pediatric overweight and obesity. Coppock, JH., Ridolfi, DR., Hayes, JF., et al.[2021]

In a randomized controlled trial involving 72 obese children, family-based behavioral treatment (FBBT) showed no significant difference in BMI reduction compared to a waiting-list control group, indicating that both groups experienced similar improvements in weight.

The treatment group did report significant reductions in systolic blood pressure and improvements in quality of life and eating attitudes, with no adverse effects noted, suggesting that while FBBT may not lead to greater weight loss, it can have positive health impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. Croker, H., Viner, RM., Nicholls, D., et al.[2022]

In a 6-month family-based treatment program for childhood obesity, both parents and children experienced significant weight loss, indicating that family involvement is crucial for effective weight management.

The study found that a parent's initial weight loss positively influenced their child's subsequent weight loss, and vice versa, highlighting the mutual influence between parent and child in achieving weight loss goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. Kang Sim, DE., Strong, DR., Manzano, MA., et al.[2022]

After 12 months of family-based obesity treatment, 40% of children with severe obesity no longer met the criteria for severe obesity, indicating the efficacy of the intervention.

Children with severe obesity showed improvements in psychosocial distress similar to those with mild obesity/overweight, suggesting that the treatment not only helps with weight loss but also supports mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. Hayes, JF., Fowler, LA., Balantekin, KN., et al.[2022]

The study found that higher baseline body mass index (BMI) in parents is positively correlated with their readiness to change their behaviors related to obesity, suggesting that those who are more affected by obesity may be more motivated to seek change.

Interestingly, Black non-Hispanic parents showed higher readiness to change compared to White and Other non-Hispanic parents, indicating that race and sociodemographic factors like education and income play a significant role in a parent's willingness to engage in obesity interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships examined: Parent and child readiness to change and sociodemographic characteristics in family based weight loss treatment. Ramel, M., Wilfley, DE., Tabak, R., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Nansel, TR., Iannotti, RJ., Liu, A.[2022]

Family-based behavioral treatment (FBBT) for childhood obesity was well-accepted in a clinical setting in the UK, with 82% of participating families completing the 12-session program.

Children in the program experienced an average BMI reduction of 8.4%, which was maintained at a 3-month follow-up, alongside improvements in self-esteem and mood, indicating the treatment's efficacy without negative psychological effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of obesity: acceptability and effectiveness in the UK. Edwards, C., Nicholls, D., Croker, H., et al.[2016]

Family-centered interventions for children with type 1 diabetes significantly improved health outcomes, specifically reducing A1C levels, enhancing family dynamics, and decreasing family conflict, based on a review of nine randomized controlled trials.

There is a need for future research to develop family-centered interventions that also consider nontraditional family structures and cultural differences, as the current studies primarily focused on traditional two-parent families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of family-centered interventions to enhance the health outcomes of children with type 1 diabetes. McBroom, LA., Enriquez, M.[2018]

In a study of 153 youth with type 1 diabetes, higher parental diabetes-specific knowledge, less negative affect in youth regarding blood glucose monitoring, and lower parental-perceived burden were all linked to better glycemic control, as measured by lower HbA1c levels.

These factors remained significant predictors of glycemic control even after accounting for other demographic and diabetes-specific variables, suggesting that enhancing parental support and reducing stress related to diabetes management can improve health outcomes for youth with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. Butler, DA., Zuehlke, JB., Tovar, A., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

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Family-Based Behavioral Treatment for Childhood Obesity ... At 24 months, children receiving family-based treatment had better weight outcomes than those receiving usual care based on the difference in ...

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Family-Based Interventions Targeting Childhood Obesity The positive effect size between treatment groups indicates that the first group (“parents only targeted”) decreased overweight 1.23% more than did the second ...

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Outcomes of a Family Based Pediatric Obesity Program However, reviews of treatment studies conducted on children in weight management programs have indicated success rates ranging from 43 to 73% (29, 38). These ...

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Family-Based Treatment for Childhood Type 1 Diabetes ... A family-based behavioral weight control intervention for 192 children aged 8 to 12 resulted in a significant 7.58% decrease in percent overweight at 6 months, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421002330

Implementing family-based behavioral treatment in the ... FBT has shown significant reductions in relative weight at 10 year follow-up in specialized (non-primary care) settings [16,17].

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Development of a Family-Based Intervention Promoting the ... The purpose of this paper is to describe the development of Behavioral Family Systems Therapy for Diabetes Transition (BFST-DT), a virtual ...

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The Wanek Family Project for Type 1 Diabetes Research Through the Wanek Family Project, City of Hope is committed to treating and reversing type 1 diabetes. Learn about our research, clinical trials and ...

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A Safety, Tolerability, and Efficacy Study of VX-880 in ... This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of ...

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Safety of a co-designed cognitive behavioural therapy ... The Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY) intervention is a diabetes specific cognitive behavioural therapy (CBT) ...