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Behavioral Intervention
Family-Based Treatment for Childhood Type 1 Diabetes and Obesity (FBT for T1D Trial)
N/A
Recruiting
Research Sponsored by University at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T1D of 12 or more months duration
Age 6-17 years
Must not have
Inability to perform at least mild physical activity such as walking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 and 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will help kids with type 1 diabetes and their families manage obesity and improve their long-term outcomes.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves lifestyle changes rather than medication, side effects may include typical reactions to increased physical activity or dietary adjustments such as muscle soreness or digestive changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had Type 1 Diabetes for at least 12 months.
Select...
I am between 6 and 17 years old.
Select...
I am overweight or obese.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot perform mild activities like walking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Weight for parent and child
Secondary study objectives
Change in HbA1c
Change in insulin dosing
Change in time in range (TIR) - that is in optimal glycemic range
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 20 Child-Parent DyadsExperimental Treatment1 Intervention
Family-Based Behavioral Treatment
Find a Location
Who is running the clinical trial?
University at BuffaloLead Sponsor
132 Previous Clinical Trials
98,916 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
362 Previous Clinical Trials
412,464 Total Patients Enrolled
State University of New York at BuffaloLead Sponsor
268 Previous Clinical Trials
52,304 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The parent shows signs of depression according to the standard PHQ assessment.I have had Type 1 Diabetes for at least 12 months.The child has other autoimmune conditions besides type 1 diabetes or autoimmune thyroiditis.You use a pump for insulin and a device to track your blood sugar levels.I am a parent with a chronic condition treated with meds that affect weight loss or limit my physical activity.A child showing signs of depression based on the Patient Health Questionnaire (PHQ) 9.My child has a condition like developmental delay or deafness that makes counseling challenging.I cannot perform mild activities like walking.Children with long-term health problems other than type 1 diabetes.A parent taking part in the study has autoimmune disorders other than type 1 diabetes or autoimmune thyroiditis.I am between 6 and 17 years old.I am a youth with at least one parent who is overweight or obese and willing to join the program with me.I am overweight or obese.My child is on medication that can affect their weight, like ADHD or asthma treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 20 Child-Parent Dyads
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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