NCT06202950

Brief Summary

The study will examine the effects of Mindfulness-Based Stress Reduction Program and yoga on stress level, quality of life and glycemic control in Youth with Type 1 diabetes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
3mo left

Started Mar 2023

Typical duration for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2023Jul 2026

Study Start

First participant enrolled

March 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

3.3 years

First QC Date

January 2, 2024

Last Update Submit

December 3, 2025

Conditions

DiabetesStress

Keywords

MindfulnessYogaType 1 DiabetesYouthStress LevelQuality of LifeGlycemic Control

Outcome Measures

Primary Outcomes (3)

  • 10-item version of the Diabetes Stress Questionnaire for Youths with Type 1 Diabetes

    use the scale with patients 12 and up and we administer it via online survey (Qualtrics). Scores vary from 0 (not at all) to 3 (very much), so the min score=0, and the max score=30. We use the clinical cut off of 12 (scores \>=12 are flagged).

    8 weeks

  • pediatrics quality of life inventoryTM (PedsQL) diabetes module 3.0 for Turkish adolescents with type 1 diabetes scale

    The 28-item multidimensional PedsQLTM 3.0 Diabetes Module included five subscales, which are diabetes symptoms (11 items), treatment barriers (4 items), treatment adherence (7 items), worry (3 items), and communication (3 items). The format

    8 weeks

  • Glycemic control form

    it is an assessment tool developed to evaulate the hemoglobin A1C

    12 weeks

Study Arms (3)

Yoga

EXPERIMENTAL

Applying yoga for one hour a week for eight weeks to with type 1 diabetes

Behavioral: Yoga

Mindfulness

ACTIVE COMPARATOR

Applying mindfulness to youth with type 1 diabetes one hour a week for eight weeks

Behavioral: Mindfulness

control

NO INTERVENTION

the control group received the usual care

Interventions

YogaBEHAVIORAL

Applying yoga for one hour a week for eight weeks to an adolescent with type 1 diabetes

Yoga
MindfulnessBEHAVIORAL

Applying mindfulness for one hour a week for eight weeks to an adolescent with type 1 diabetes

Mindfulness

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Youth with Type 1 diabetes between the ages of 13 and 18 with a diabetes age of at least 12 months
  • Not having participated in a Mindfulness-Based Stress Reduction Program or doing yoga before,
  • Speaking and understanding Turkish,
  • Able to read and write,
  • Having no other physiological or psychological diseases,
  • No mental disability,
  • Not using psychoactive drugs,
  • Parents volunteered for their child to participate in the research and signed the consent form,
  • During the application phase, you should have eaten 1.5-2 hours before the application and your blood sugar should be between 150-200mg/dl before the application

You may not qualify if:

  • Failed to complete the program
  • Youth diagnosed with acute or chronic diseases in addition to diabetes during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emine Sarıkamış Kale

Batman, Merkez, 72000, Turkey (Türkiye)

Location

Hasan Kalyoncu University

Gaziantep, Sahinbey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

YogaMindfulness

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical asistant

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

March 15, 2023

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

December 4, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Locations

TU(2)