Type 1 Diabetes
Conditions
Keywords
motivational interviewing, problem solving skills training, family communication, social support, adolescents
Brief summary
The purpose of this study is to see if a behavioral intervention for adolescents with type 1 diabetes will improve adherence to T1D self-management activities and improve diabetes outcomes. We expect the intervention to improve diabetes outcomes when compared to usual care.
Detailed description
The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support. All FL3X intervention participants will receive FL3X-Basic, which is the initial 3-month intervention that includes 4 sessions (40-60 min), supplemented with short additional contacts (via text, email, or web-based communication) as needed. Thereafter, applying principles of adaptive interventions, based on a decision rule using A1c values measured at defined intervals, participants are iteratively assigned to FL3X-Check-in or FL3X-Regular, both of which continue with MI and PSST for the underlying counseling strategy. In FL3X-Check-in, participants who are doing well (responders) will receive minimal ongoing support to reinforce successful strategies through brief monthly touch-base contacts. In FL3X-Regular, those who are Regular-responders will have a minimum of 3-4 in-person full-length sessions (40-60 min) over each 6-month interval, with additional brief contacts as needed (e.g., text, voice, or internet). FL3X participants randomized to the control group will receive usual care.
Interventions
BEHAVIORALFL3X: Flexible Lifestyle Empowering Change
The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital Medical Center, Cincinnati
University of Colorado, Denver
University of Washington
Nemours Children's Clinic
University of Pittsburgh
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* type 1 diabetes with duration at least 12 months * between ages 12-16 years at registration * poor glycemic control (A1c 8.0-13.0%) * parent/guardian willing to also participate * not planning on moving in the following 18 months
Exclusion criteria
* pregnant (if female) * diabetes type 2 or gestational * Pre-existing systemic chronic disease (drug abuse, cancer, certain psychiatric conditions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 0, 3, 6, 12, 18, 24, 30 months | HbA1c will be measured to determine impact on glucose control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation | 0, 3, 6, 12, 18, 24, 30 months | Motivation related to diabetes care will be assessed |
| Problem solving skills | 0, 3, 6, 12, 18, 24, 30 months | Assess use of problem solving skills relative to diabetes care |
| Hypoglycemia | 0, 6, 18 mo | Monitoring low blood sugar from continuous glucose monitoring |
| Risk factors for diabetes complications | 0, 3, 6, 12, 18, 24, 30 months | Assess variables related to diabetes complications |
| Health-related quality of life | 0, 3, 6, 12, 18, 24, 30 months | Assess health-related quality of life |
| Diabetes self-management behaviors | 0, 3, 6, 12, 18, 24, 30 months | Assess use of diabetes self-management behaviors |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost of intervention delivery | 0-30 months | The study will evaluate cost to deliver intervention compared to usual care. |
Countries
United States
Outcome results
None listed