Culturally Relevant Exercise for Diabetes (CURE-D)

Diabetes Mellitus Clinical Trial

— CURE-D  

Official title:

Culturally Relevant Exercise for Diabetes (CURE-D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061618
• Other study ID #: 13-07-250
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: April 1, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Bollywood Dance Exercise

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation Research Institute	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		Baseline	No
Primary	Hemoglobin A1c	Change from Baseline in Hemoglobin A1c level at 8 weeks	8-week follow-up	No
Secondary	Body Mass Index		Baseline, 8-week follow-up	No
Secondary	Blood Pressure		Baseline, 8-week follow-up	No
Secondary	Physical Activity	Assessed by accelerometers	Baseline, 8-week follow-up	No