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

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{9 10 11 12 13}

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

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]

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-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]

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]

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 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 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]

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]

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]

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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effects of behavioral family systems therapy for diabetes on adolescents' family relationships, treatment adherence, and metabolic control. [2022]

2. United States 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Denmark pubmed.ncbi.nlm.nih.gov

The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. [2022]

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Relationships examined: Parent and child readiness to change and sociodemographic characteristics in family based weight loss treatment. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Family-based treatment of severe pediatric obesity: randomized, controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of obesity: acceptability and effectiveness in the UK. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Current approaches to the management of pediatric overweight and obesity. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. [2022]