Integrative, mindfulness group therapy in adolescents with diabetes

ISRCTN	ISRCTN15165508
DOI	https://doi.org/10.1186/ISRCTN15165508
The DAISY Foundation HE Grant No.	HEG-2024-1142
Sponsor	DAISY Foundation
Funder	DAISY Foundation

Submission date: 03/01/2026
Registration date: 06/01/2026
Last edited: 06/01/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Mrs Ashley Lekach
Principal investigator, Scientific, Public

325 Clinton Ave, 14 E
Brooklyn
11205
United States of America

ORCID ID	0009-0008-1792-0221
Phone	+18504455631
Email	ASL9041@nyp.org

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Supportive care, Treatment
Scientific title	A pilot study of an 8-week, group-based, chakra-informed kundalini yoga intervention for adolescents and young adults with diabetes: feasibility, youth outcomes, and caregiver distress
Study objectives	The purpose of this prospective pilot-based intervention is to evaluate the feasibility, safety, and efficacy of an integrative multi-modal, small-group, wellness intervention for adolescents aged 12-21, diagnosed with Type I and II diabetes. This research will explore integrative therapies' potential to improve blood sugar control, stress and inflammation in children and young adults living with diabetes.
Ethics approval(s)	Approved 03/04/2024, NewYork-Presbyterian Brooklyn Methodist Hospital Institutional Review Committee (NewYork-Presbyterian Brooklyn Methodist Hospital, 506 6th Street, Brooklyn, 11215-9008, United States of America; +1 718/780-5575; pcfullar@nyp.org), ref: 2174522
Health condition(s) or problem(s) studied	Diabetes, Diabetes related distress, Depression, Anxiety, Perceived Stress, Glycemic control, Caregiver related diabetes distress
Intervention	The 8-week intervention includes a series of therapeutic sessions in small groups (3-5 people) utilizing integrative therapy for about 1.5-2 hours. Sessions will be held in a private room on the hospital campus, facilitated by the Primary Investigator, an FNP and Certified Yoga instructor. The format for each session will follow a theme and start with a meditation or prompt, followed by journaling & reflection, group sharing & affirmation, and kinesthetics, specifically, yoga postures. Participants will be given care kits: yoga mat, blocks, strap, water bottle, journal, and pen. In addition to the 8-week intervention, the study participants will complete study procedures as shown below for intervals of baseline, week 8 and 3 months: Research surveys: PSS-10, DDS-17 & PDDS-18 Routine visit surveys: Social Determinant of Health, General Anxiety Disorders (GAD-7), and Patient Health Questionnaire (PHQ-9) extracted from the electronic medical record Biometrics: Body Mass Index, weight, waist circumference Vitals: Oxygen saturation, heart rate, respiratory rate, and blood pressure Devices: Continuous Glucose Monitor (CGM) Laboratory tests: Cortisol, CRP, IL-6, TNF-a, adiponectin, leptin, adiponectin-leptin ratio, HbA1c, vitamin D, TSH, fT4, Creatinine/albumin ratio, lipid profile. Intervention Schedule: Last Saved Version: March 15, 2024 Page 5 of 8 • Baseline (preliminary labs, biometrics, surveys: SDOH, PHQ9, GAD, DDS-17, PDDS18, PSS-10, CGM within 2+ weeks of intervention, consent). • Week 1: Root: Security, Grounding, Stability • Week 2: Sacral: Passion, Creativity • Week 3: Solar Plexus: Personal, Power, Confidence • Week 4: Heart: Love, Kindness, Harmony • Week 5: Throat: Truth, Honesty, Self-Expression • Week 6: Third Eye: Intuition, Insight, Perception • Week 7: Crown: Elevating Connections • Week 8: Closing Ceremony (Reflection/Feedback Survey) • Upon completion of the program repeat: Labs, biometrics, surveys: DDS-17, PDDS-18, PSS-10, GAD, PHQ9, CGM not exceeding 1-2 weeks • Schedule 3-month post-intervention endocrine follow-up clinic visit. Obtain final labs, biometrics, surveys: DDS-17, PDDS-18, PSS-10, GAD, PHQ9, CGM 3-month summary
Intervention type	Behavioural
Primary outcome measure(s)	Diabetes related distress measured using the Diabetes Distress Scale 17‑item (DDS-17) at baseline (pre), on completion of the program (post), and 3-month follow up Parental diabetes related distress measured using the Parental‑Determined Disease Steps (18‑item (PDDS-20) at baseline (pre), on completion of the program (post), and 3-month follow up Depression measured using the Patient Health Questionnaire 9‑item (PHQ-9) at baseline (pre), on completion of the program (post), and 3-month follow up
Key secondary outcome measure(s)
Completion date	01/11/2025

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	14 Years
Upper age limit	21 Years
Sex	All
Target sample size at registration	15
Total final enrolment	13
Key inclusion criteria	1. For the intervention, adolescents aged 12-21 years, all genders, have a minimum of 1 year DM history and type 1 or type 2 diabetes as defined by the American Diabetes Association. Participants who are proficient in English, at a minimum of 3rd grade reading level (for the purpose of consent/assent). 2. Caregiver(s) will be invited to participate in the SDOH (once during consent) and the PDSS survey at pre,-post, and at the 3 month follow up visit with endocrinology. A caregiver is considered any member of the family that directly interacts with daily diabetes management.
Key exclusion criteria	1. Adolescents less than 12 years of age 2. Non-English speaking 3. Less than 1 year history of type 1 and type 2 diabetes as defined by the American Diabetes Association
Date of first enrolment	01/07/2024
Date of final enrolment	05/08/2024

Locations

Countries of recruitment

United States of America

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

06/01/2026: Study’s existence confirmed by the NewYork-Presbyterian Brooklyn Methodist Hospital Institutional Review Committee, United States of America.