Diabetes MellitusCURE-DNCT02061618
Culturally Relevant Exercise for Diabetes (CURE-D)
A study testing Bollywood Dance Exercise in people with Diabetes Mellitus, run by Palo Alto Medical Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Bollywood Dance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Bollywood Dance Exercise
- Keywords
- South Asian
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bollywood Dance ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| 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. Receives: Behavioral: Bollywood Dance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Measured: Baseline
Hemoglobin A1c
Change from Baseline in Hemoglobin A1c level at 8 weeks
Measured: 8-week follow-up
Secondary outcomes (3)
Body Mass Index
Measured: Baseline, 8-week follow-up
Blood Pressure
Measured: Baseline, 8-week follow-up
Physical Activity
Assessed by accelerometers
Measured: Baseline, 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Latha Palaniappan, MD, MS, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061618
- Sponsor's protocol ID
- 13-07-250
- Acronym
- CURE-D
- Status last verified
- Apr 2015
- First submitted
- 10 Feb 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26566446
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Relevant Exercise for Diabetes (CURE-D)
- ClinicalTrials.gov ID
- NCT02061618
- Acronym / sponsor ID
- CURE-D / 13-07-250
- Conditions
- Diabetes Mellitus
- Keywords
- South Asian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | – |
| Bollywood Dance Exercise | Experimental | Behavioral: Bollywood Dance ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- BMI > 35
- Insulin dependent
- Current atrial fibrillation
- Active treatment for cancer
- Diagnosis of a terminal illness and/or in hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bollywood Dance Exercise | Behavioural | Bollywood Dance Exercise |
Primary outcome
Hemoglobin A1c
Time frame: Baseline
Hemoglobin A1c
Time frame: 8-week follow-up
Change from Baseline in Hemoglobin A1c level at 8 weeks
3 secondary outcomes
Body Mass Index
Time frame: Baseline, 8-week follow-up
Blood Pressure
Time frame: Baseline, 8-week follow-up
Physical Activity
Time frame: Baseline, 8-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 26566446Natesan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bollywood Dance Exercise in people with Diabetes Mellitus, run by Palo Alto Medical Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.