Family-Based Treatment for Type 1 Diabetes (FBT for T1D)
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ClinicalTrials.gov Identifier: NCT05756361 |
Recruitment Status :
Not yet recruiting
First Posted : March 6, 2023
Last Update Posted : March 6, 2023
|
Sponsor:
University at Buffalo
Information provided by (Responsible Party):
Teresa Quattrin, University at Buffalo
Brief Summary:
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 Obesity, Childhood Overweight Comorbidities and Coexisting Conditions | Behavioral: Family-Based Treatment for T1D | Not Applicable |
Show detailed description
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Family-Based Approach to Treat Obesity and Its Co-morbidities in Youth With Type 1 Diabetes (T1D) and Their Parents |
Estimated Study Start Date : | March 20, 2023 |
Estimated Primary Completion Date : | March 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 1 diabetes
Arm | Intervention/treatment |
---|---|
Experimental: 20 Child-Parent Dyads
Family-Based Behavioral Treatment
|
Behavioral: Family-Based Treatment for T1D
Our FBT curriculum, which has been delivered successfully in the specialty and primary care settings, has 3 components: 1. Meal planning including quality of carbohydrates and glycemic index for both parents and children while ensuring that youth have a balanced meal plan with adequate amounts of carbohydrates for optimal growth. Our FBT has a focus on "Food Literacy" including healthy food selection and sourcing of affordable healthy food, food preparation and preplanning, social engagement tailoring the meal plan to the needs to the family in socio cultural appropriate way and also feasibility based on logistics and economic aspects; 2. Physical activity (PA) component with shaping strategy to allow for a progressive shaping of easy PA starting, if needed, with as little as with 10 minutes of walking/day and strategies to incorporate PA in daily routines, family, and social activities; 3. Extensive behavioral component which has been shown to be very powerful in obesity treatment |
Primary Outcome Measures :
- Change in Weight for parent and child [ Time Frame: Baseline, 3 and 6 months ]Participants will be given Body Trace Weight Scales and will weigh themselves twice per week.
Secondary Outcome Measures :
- Change in insulin dosing [ Time Frame: baseline, 3 and 6 months ]Metrics will be obtained through Insulin pumps
- In parents, change in severity of obesity co-morbidities [ Time Frame: baseline, 3 and 6 months ]Participants will be given Body Trace Weight Scales and will weigh themselves twice per week. Parent co-morbidities will be tracked on a sheet
- Change in HbA1c [ Time Frame: baseline, 3 and 6 months ]Metrics will be obtained through Continuous Glucose Monitor
- Change in time in range (TIR) - that is in optimal glycemic range [ Time Frame: baseline, 3 and 6 months ]Metrics will be obtained through Continuous Glucose Monitor
- In parents, change in medication dosing [ Time Frame: baseline, 3 and 6 months ]Parent medications will be tracked on a sheet.
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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- T1D of 12 or more months duration
- Age 6-17-years
- Presence of overweight/obesity
- Youth uses a pump for insulin delivery and a continuous glucose monitoring device to monitor glycemic levels
- Youth has one parent with overweight/obesity willing to participate in the program
Exclusion Criteria:
-
Child:
- Chronic conditions other than T1D
- Other autoimmune conditions other then T1D or autoimmune thyroiditis.
- Medications that can affects weight, such as medications used to treat Attention Deficit Disorder or high dose steroids used to treat asthma.
- Depression symptoms by standard of care Patient Health Questionnaire (PHQ) 9 in the child or parent
- Inability to perform at least mild physical activity such as walking
- Child with handicap (such as developmental delay or deafness) that would prevent him/her from benefitting from counseling in person and/or remotely Participating parent with
- symptoms of depression assessed by standard of care PHQ
- autoimmune disorders other than T1D or autoimmune thyroiditis
- Participating parents with chronic disorder that is treated with medications that interfere with weight loss or are preventing him/her from performing at least mild physical activity
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05756361
Contacts
Contact: Teresa Quattrin, MD | (716) 480-3185 | tquattrin@upa.chob.edu | |
Contact: Andy Strohmeier, M.Ed. | (716) 480-3185 | awstrohm@buffalo.edu |
Sponsors and Collaborators
University at Buffalo
Responsible Party: | Teresa Quattrin, Principal Investigator, University at Buffalo |
ClinicalTrials.gov Identifier: | NCT05756361 |
Other Study ID Numbers: |
STUDY00006622: FBT for T1D |
First Posted: | March 6, 2023 Key Record Dates |
Last Update Posted: | March 6, 2023 |
Last Verified: | February 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Diabetes Mellitus Obesity Diabetes Mellitus, Type 1 Pediatric Obesity Overweight Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Overnutrition Nutrition Disorders Body Weight Autoimmune Diseases Immune System Diseases |