HIV InfectionsPhase 1NCT00090506
Yoga for Treating People at Risk for Diabetes or With Both HIV and Depression
A Phase 1 study testing Yoga in people with HIV Infections and Diabetes, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in India.
Trial summary
The purpose of this study is to plan and develop an international collaboration for research on the health effects of yoga. This study will also determine the effects of yoga on people who are at an increased risk for developing diabetes and people with both HIV and depression. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- HIV Infections, Diabetes, Depression
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2004to Mar 2007
- Phase
- Phase 1
- 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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet certain laboratory requirements
- HIV infected
- Able to walk at least 50% of the time
- Written informed consent of parent/guardian, if applicable
Who cannot join
- Require antiretroviral therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yoga, Health, and Meditation
The purpose of this study is to plan and develop an international collaboration for research on the health effects of yoga. This study will also determine the effects of yoga on people who are at an increased risk for developing diabetes and people with both HIV and depression.
Read the detailed description
In recent years, western health practitioners have become increasingly aware of the potential health benefits of yoga. This study will comprise two substudies that will evaluate the effects of yoga in two distinct populations.
Participants in the first study will be people who are at risk for developing diabetes; participants in the second study will be people with both HIV and depression. All participants will practice yoga 3 to 6 days per week for 3 months. Blood collection will be done and weight and blood pressure measurements will be taken in study 1 participants; questionnaires will be used to measure depression and stress in study 2 participants. All study participants will be assessed at entry and at 3 and 6 months.
- Conditions
- HIV Infections, Diabetes, Depression
- Being tested
- Yoga
- Keywords
- Yoga, Meditation
- Medical subject headings
- HIV Infections, Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2004 (estimated)
- Study startJul 2004
- Primary completionMar 2007
- Study completionMar 2007
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 HIV InfectionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Frederick M. Hecht, MD, Principal investigator, UCSF Positive Health Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090506
- Sponsor's protocol ID
- R21AT001942-01
- Status last verified
- Jan 2008
- First submitted
- 26 Aug 2004
- Last updated
- 25 Jan 2008
- Results posted
- No
Publications
McDermott KA, Rao MR, Nagarathna R, Murphy EJ, Burke A, Nagendra RH, Hecht FM. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial. BMC Complement Altern Med. 2014 Jul 1;14:212. doi: 10.1186/1472-6882-14-212.
PubMed 24980650
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga, Health, and Meditation
- ClinicalTrials.gov ID
- NCT00090506
- Acronym / sponsor ID
- R21AT001942-01
- Conditions
- HIV Infections, Diabetes, Depression
- Keywords
- Yoga, Meditation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jul 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 27 Aug 2004 (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 purpose of this study is to plan and develop an international collaboration for research on the health effects of yoga. This study will also determine the effects of yoga on people who are at an increased risk for developing diabetes and people with both HIV and depression.
Detailed description
In recent years, western health practitioners have become increasingly aware of the potential health benefits of yoga. This study will comprise two substudies that will evaluate the effects of yoga in two distinct populations.
Participants in the first study will be people who are at risk for developing diabetes; participants in the second study will be people with both HIV and depression. All participants will practice yoga 3 to 6 days per week for 3 months. Blood collection will be done and weight and blood pressure measurements will be taken in study 1 participants; questionnaires will be used to measure depression and stress in study 2 participants. All study participants will be assessed at entry and at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Meet certain laboratory requirements
- HIV infected
- Able to walk at least 50% of the time
- Written informed consent of parent/guardian, if applicable
Key exclusion criteria (1 listed)
- Require antiretroviral therapy
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 |
|---|---|---|
| Yoga | Behavioural | – |
Primary outcome
Not reported in the source record.
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 25 Jan 2008.
- Derived from this study: PubMed 24980650McDermott KA, Rao MR, Nagarathna R, Murphy EJ, Burke A, Nagendra RH, Hecht FM. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial. BMC Complement Altern Med. 2014 Jul 1;14:212. doi: 10.1186/1472-6882-14-212.
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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.
Frederick M. Hecht, MD principal investigator
UCSF Positive Health Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Yoga in people with HIV Infections and Diabetes, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in India.
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 4 inclusion and 1 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 25 Jan 2008. 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 India. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00090506, 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 25 Jan 2008.