ACTIVE_NOT_RECRUITING

Family-Based Treatment for Type 1 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Family-Based Approach to Treat Obesity and Its Co-morbidities in Youth With Type 1 Diabetes (T1D) and Their Parents

Quick Facts

Study Start:2023-04-26
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05756361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * T1D of 12 or more months duration
  2. * Age 6-17-years
  3. * Presence of overweight/obesity
  4. * Youth uses a pump for insulin delivery and a continuous glucose monitoring device to monitor glycemic levels
  5. * Youth has one parent with overweight/obesity willing to participate in the program
  1. * Child:
  2. * Chronic conditions other than T1D
  3. * Other autoimmune conditions other then T1D or autoimmune thyroiditis.
  4. * Medications that can affects weight, such as medications used to treat Attention Deficit Disorder or high dose steroids used to treat asthma.
  5. * Depression symptoms by standard of care Patient Health Questionnaire (PHQ) 9 in the child or parent
  6. * Inability to perform at least mild physical activity such as walking
  7. * 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
  8. * symptoms of depression assessed by standard of care PHQ
  9. * autoimmune disorders other than T1D or autoimmune thyroiditis
  10. * 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

Contacts and Locations

Study Locations (Sites)

Conventus
Buffalo, New York, 14203
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-26
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-04-26
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 1
  • Obesity, Childhood
  • Overweight
  • Comorbidities and Coexisting Conditions