NCT02607566

Brief Summary

This study will examine the feasibility and acceptability of a twice weekly yoga program for adults with type 2 diabetes. Changes in perceived stress, salivary cortisol, and HbA1c will also be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 25, 2019

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

November 12, 2015

Last Update Submit

April 23, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesYogaWalkingStressexerciseglycemic control

Outcome Measures

Primary Outcomes (2)

  • Acceptability as measured by session attendance

    Number of sessions attended

    12 weeks

  • Feasibility as measured by study completion

    Percent of enrolled subjects completing all assessments

    6 months

Secondary Outcomes (4)

  • Changes in diabetes-related distress as measured by Diabetes Related Distress Survey

    Baseline to Week 12

  • Changes in Salivary Cortisol (ug/dL) between baseline and week 12

    Baseline to Week 12

  • HbA1c

    6 months

  • Diabetes Self-Care

    12 weeks

Study Arms (2)

Iyengar Yoga

EXPERIMENTAL

Iyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks.

Behavioral: Yoga

Standard Exercise Program

ACTIVE COMPARATOR

professionally supervised program of aerobic exercise including use of an indoor walking track, treadmills, stationary bicycles and elliptical machines, held for 60 minutes twice weekly for 12 weeks

Behavioral: Standard Exercise Program

Interventions

YogaBEHAVIORAL
Iyengar Yoga
Standard Exercise ProgramBEHAVIORAL

twice weekly aerobic exercise program, 60 minutes for 12 weeks

Standard Exercise Program

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes for more than 6 months
  • HbA1c \> 6.5
  • Body Mass Index \< 42

You may not qualify if:

  • Serious co-morbid condition (e.g. uncontrolled hypertension, glaucoma, heart failure)
  • Complications of diabetes (e.g. diabetic retinopathy, neuropathy, nephropathy)
  • Serious psychiatric disorder (e.g. psychosis, major depression, panic attacks, suicidality, or substance dependence)
  • Body Mass Index of 42 or greater
  • Pregnancy or planned pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Miriam Hospital- CORO building

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (4)

  • Thind H, Fava JL, Guthrie KM, Stroud L, Gopalakrishnan G, Sillice M, Gidron N, Bock BC. Yoga as a Complementary Therapy for Adults with Type 2 Diabetes: Design and Rationale of the Healthy, Active, and in Control (HA1C) Study. Int J Yoga Therap. 2018 Nov;28(1):123-132. doi: 10.17761/2018-00026. Epub 2018 Aug 21.

    PMID: 30130144BACKGROUND

  • Thind H, Guthrie KM, Horowitz S, Conrad M, Bock BC. "I can do almost anything": The experience of adults with type 2 diabetes with a yoga intervention. Complement Ther Clin Pract. 2019 Feb;34:116-122. doi: 10.1016/j.ctcp.2018.11.011. Epub 2018 Nov 16. No abstract available.

    PMID: 30712714RESULT

  • Bock BC, Thind H, Fava JL, Dunsiger S, Guthrie KM, Stroud L, Gopalakrishnan G, Sillice M, Wu W. Feasibility of yoga as a complementary therapy for patients with type 2 diabetes: The Healthy Active and in Control (HA1C) study. Complement Ther Med. 2019 Feb;42:125-131. doi: 10.1016/j.ctim.2018.09.019. Epub 2018 Sep 26.

    PMID: 30670230RESULT

  • Thind H, Lantini R, Balletto BL, Donahue ML, Salmoirago-Blotcher E, Bock BC, Scott-Sheldon LAJ. The effects of yoga among adults with type 2 diabetes: A systematic review and meta-analysis. Prev Med. 2017 Dec;105:116-126. doi: 10.1016/j.ypmed.2017.08.017. Epub 2017 Sep 4.

    PMID: 28882745RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusMotor Activity

Interventions

Yoga

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Beth Bock, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 18, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

September 1, 2017

Last Updated

April 25, 2019

Record last verified: 2015-11

Locations

US(2)