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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Joslin Diabetes Center
Study ID
NCT05413239
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Psychoeducation to reduce diabetes distress and improve glycemic outcomes — 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.

Study Details

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.

Key Dates

Start date
Jul 26, 2022
Status verified
Mar 2026
Primary completion
Nov 30, 2024
Completion
Feb 1, 2026

Study Design

Enrollment
217 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    The Intervention Group will receive the monthly intervention sessions during the first year of the study.
  • No Intervention: 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).

Primary Outcome Measure

Time in Range (TIR) [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305-
Joslin Diabetes CenterBostonMassachusetts02215-

Find similar trials in Palo Alto, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Stanford University· Palo Alto, CAJoslin Diabetes Center· Boston, MA

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