Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)

NCT ID: NCT05413239

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2025-11-30

Brief Summary

In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.

Detailed Description

In this study, we will recruit 180 adolescents and young adults (ages 14-25) with type 1 diabetes for at least 1 year and suboptimal diabetes control (A1c 7-13%) to participate in a 2-year randomized clinical trial aimed at reducing diabetes distress and improving glycemic outcomes. Adolescents and young adults with type 1 diabetes represent a population that often has uncontrolled diabetes with elevated A1c levels and experiences diabetes distress, making such patients ideal for this study. Participants will be randomly assigned to one of two groups (control or intervention). The intervention group will participate in monthly intervention sessions with a research assistant during the first year of the study. Four sessions will focus on improving glycemic outcomes and 8 sessions will focus on reducing diabetes distress. The sessions will be conducted face-to-face or remotely. To ensure adequate recruitment and retention, the control group will participate in the intervention sessions during the second year of the study. Participants in both groups will use continuous glucose monitoring (CGM), with CGM data downloaded every 3 months. Participants in both groups will complete surveys and have A1c measured every 6 months. We will compare the two groups on percent time in target glucose range (70-180 mg/dL), A1c, and diabetes distress from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent time in range, A1c, and diabetes distress, compared with the control group.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention Group

The Intervention Group will receive the monthly intervention sessions during the first year of the study.

Group Type: EXPERIMENTAL

Psychoeducation to reduce diabetes distress and improve glycemic outcomes

Intervention Type: BEHAVIORAL

The intervention includes two types of sessions - those targeting an improvement in glycemic outcomes and those targeting a reduction in diabetes distress. Evidence indicates that psychoeducation and support are needed to improve self-care behaviors and optimize use of advanced diabetes technologies, which, in turn, can help improve diabetes control while also reducing diabetes distress. Participants will receive 4 one-on-one glycemic sessions and 8 one-on-one distress sessions, each lasting \~30 minutes. Sessions will be conducted in-person or remotely. The virtual sessions are intended to provide the extra psychoeducation and support needed for this high risk group without increasing the burden associated with frequent face-to-face sessions.

Control Group

The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychoeducation to reduce diabetes distress and improve glycemic outcomes

The intervention includes two types of sessions - those targeting an improvement in glycemic outcomes and those targeting a reduction in diabetes distress. Evidence indicates that psychoeducation and support are needed to improve self-care behaviors and optimize use of advanced diabetes technologies, which, in turn, can help improve diabetes control while also reducing diabetes distress. Participants will receive 4 one-on-one glycemic sessions and 8 one-on-one distress sessions, each lasting \~30 minutes. Sessions will be conducted in-person or remotely. The virtual sessions are intended to provide the extra psychoeducation and support needed for this high risk group without increasing the burden associated with frequent face-to-face sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 14-25 years
• Diagnosis of type 1 diabetes (according to ADA criteria)
• Type 1 diabetes duration ≥12 months
• A1c 7-13%
• Smartphone or regular access to wifi via computer
• Fluency in English at a 5th grade level or higher (based on investigator assessment of grade level in school or highest grade level achieved and presence in mainstream academic classes)

Exclusion Criteria

• Physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism)
• Participation in another intervention study within the last 3 months
• Currently pregnant or intending to become pregnant during the study (assessed by self-report)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori M Laffel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Korey K Hood, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK129479

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000154

Identifier Type: -

Identifier Source: org_study_id