NCT04982640

Brief Summary

This study will randomize 90 adults with type-2 diabetes (T2DM) from three different states (RI, MA, and AL) to a 12-week program of either (1) Iyengar yoga or (2) a Standard Exercise program. Follow up assessments occur at 3 and 6-months post-intervention. Results of this study will determine the ability to deliver these interventions with strong rigor and fidelity across multiple sites and will establish the feasibility and acceptability of this intervention across racially and ethnically diverse populations. The study will also examine factors (e.g., outcome expectations, barriers to home practice) that promote long-term adherence to yoga and/or physical activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 4, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 24, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

July 4, 2021

Last Update Submit

April 17, 2025

Conditions

Type2 Diabetes

Keywords

DiabetesYogaPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Feasibility assessed as session attendance

    Each participant is scheduled for 36 classes in total. The percent of classes attended is calculated for each participant to determine feasibility. If the average percentage of classes attended for all participants exceeds 70% the intervention will be deemed feasible.

    12 weeks

  • Acceptability as indicated by participant satisfaction ratings

    The participant satisfaction scale contains 10 items using a Likert scale from 1 (not at all satisfied) to 5 (very satisfied). Scale items will be summed and averaged for each participant. Scores from all participants are averaged. If the overall average score from all participants is 4 or greater the program will be considered satisfactory.

    12 weeks

Secondary Outcomes (4)

  • Hemoglobin A1c

    6 months

  • Diabetes Distress as measured by the Problem Areas in Diabetes Scale

    12 weeks

  • Fasting Blood Glucose

    12 weeks

  • Body Mass Index

    6 months

Study Arms (2)

Yoga

EXPERIMENTAL

12-week program, 60 minutes, twice weekly group-delivered Iyengar yoga

Behavioral: Iyengar yogaBehavioral: Nutrition Counseling

Standard Exercise

ACTIVE COMPARATOR

12-week, 60 minutes, twice weekly group-delivered aerobic exercise (e.g., walking) program

Behavioral: Standard ExerciseBehavioral: Nutrition Counseling

Interventions

Iyengar yogaBEHAVIORAL

60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks

Yoga
Standard ExerciseBEHAVIORAL

60 minutes, twice weekly for 12 weeks, group-based walking program

Standard Exercise
Nutrition CounselingBEHAVIORAL

One, 30-minute session with registered dietitian

Standard ExerciseYoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Diagnosis of type-2 diabetes, stable on medications
  • Physician clearance

You may not qualify if:

  • Serious comorbid condition (such as uncontrolled hypertension, glaucoma, heart failure).
  • Complications of diabetes such as diabetic retinopathy, neuropathy and nephropathy
  • Serious psychiatric disorder (e.g. psychosis, major depression, panic attacks, suicidality, or substance dependence).
  • Extremely obese (i.e. Body Mass Index \> 45 kg/m2)
  • Currently engaged in yoga, Tai Chi, or other mindfulness-based practice the past six months
  • Pregnant or trying to become pregnant
  • Inability to read and write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital- CORO building

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Codes identifying randomization assignment are withheld from the research staff conducting study outcome assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 29, 2021

Study Start

October 24, 2022

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)