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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02061618
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Latha Palaniappan, MD, MS, Palo Alto Medical Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Bollywood Dance Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Culturally Relevant Exercise for Diabetes (CURE-D)
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: Baseline ]
  2. Hemoglobin A1c [ Time Frame: 8-week follow-up ]
    Change from Baseline in Hemoglobin A1c level at 8 weeks


Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: Baseline, 8-week follow-up ]
  2. Blood Pressure [ Time Frame: Baseline, 8-week follow-up ]
  3. Physical Activity [ Time Frame: Baseline, 8-week follow-up ]
    Assessed by accelerometers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061618


Locations
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United States, California
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301
Sponsors and Collaborators
Palo Alto Medical Foundation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Latha Palaniappan, MD, MS, Associate Investigator, Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT02061618     History of Changes
Other Study ID Numbers: 13-07-250
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Latha Palaniappan, MD, MS, Palo Alto Medical Foundation:
South Asian

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases