Culturally Relevant Exercise for Diabetes (CURE-D) (CURE-D)

April 1, 2015 updated by: Latha Palaniappan, MD, MS, Palo Alto Medical Foundation
The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a culturally-sensitive dance intervention is an accepted and effective physical intervention for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if Bollywood dance exercise improves diabetes outcomes in South Asian women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Sex: Females
  • Ethnicity: South Asian
  • Hemoglobin A1c ≥ 6.0 mg/dL
  • A PAMF patient for ≥ 24 months
  • Able and willing to enroll and meet the requirements of the study.

Exclusion Criteria:

  • BMI > 35
  • Insulin dependent
  • Current atrial fibrillation
  • Active treatment for cancer
  • Diagnosis of a terminal illness and/or in hospice care
  • Any serious medical condition which would prevent long-term participation or which would contraindicate physical activity
  • Pregnant, lactating, or planning to become pregnant during the study period
  • Inability to speak, read, or understand English
  • No longer a PAMF patient or planning to transfer care outside of PAMF during the study period
  • Investigator discretion for clinical safety or protocol adherence reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual Care
EXPERIMENTAL: Bollywood Dance Exercise
Participants in the Bollywood Dance Exercise group will take part in an 8-week dance intervention. The dance classes will take place 2 times per week, approximately 60 minutes per class, for 8 weeks total.
Behavioral: Bollywood Dance Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: Baseline
Baseline
Hemoglobin A1c
Time Frame: 8-week follow-up
Change from Baseline in Hemoglobin A1c level at 8 weeks
8-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: Baseline, 8-week follow-up
Baseline, 8-week follow-up
Blood Pressure
Time Frame: Baseline, 8-week follow-up
Baseline, 8-week follow-up
Physical Activity
Time Frame: Baseline, 8-week follow-up
Assessed by accelerometers
Baseline, 8-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (ESTIMATE)

February 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-07-250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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