- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02061618
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
-
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California
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Palo Alto, California, United States, 94301
- Palo Alto Medical Foundation Research Institute
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-
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
|
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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.
|
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
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.
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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