NCT02061618

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

February 10, 2014

Last Update Submit

April 1, 2015

Conditions

Keywords

South Asian

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin A1c

    Baseline

  • Hemoglobin A1c

    Change from Baseline in Hemoglobin A1c level at 8 weeks

    8-week follow-up

Secondary Outcomes (3)

  • Body Mass Index

    Baseline, 8-week follow-up

  • Blood Pressure

    Baseline, 8-week follow-up

  • Physical Activity

    Baseline, 8-week follow-up

Study Arms (2)

Usual Care

NO INTERVENTION

Bollywood Dance Exercise

EXPERIMENTAL

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

Interventions

Bollywood Dance Exercise

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

Related Publications (1)

  • Natesan A, Nimbal VC, Ivey SL, Wang EJ, Madsen KA, Palaniappan LP. Engaging South Asian women with type 2 diabetes in a culturally relevant exercise intervention: a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 Oct 28;3(1):e000126. doi: 10.1136/bmjdrc-2015-000126. eCollection 2015.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Investigator

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 13, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations