DiabetesSHAPENCT01084928
A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians
A study testing Lifestyle Intervention Classes in people with Diabetes and Obesity, run by Emory University at 1 site in United States.
Trial summary
The South Asian Community, people with origins in India, Pakistan, Bangladesh, Maldives, Nepal, Sri Lanka, or Bhutan, are more likely to get diabetes, get diabetes at younger ages, and do worse health-wise once they have diabetes than the general population. Read more about this study
- Who is it for?
- Ages 25 years and older
- What is being tested?
- Lifestyle Intervention Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2012
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified as being of South Asian origin
- Live in or near Atlanta, Georgia
- BMI greater than 22 kg/m2 calculated from standardized weight and height measurements (a BMI of greater than 22 kg/m2 is indicative of overweight in the South Asian population)
- A confirmed age greater than or equal to 25 determined by checking a valid photo identification (driver's license, passport, etc.)
- No prior diabetes diagnosis (physician diagnosis or on diabetes medication)
- A high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 120 (measured during screening)
- Fasting glucose of 100-125 mg/dL (impaired fasting glucose tolerance) and/or 2-hour post-load glucose of 140-199 mg/dL (impaired glucose tolerance), measured at baseline visit
- No history of heart disease, serious illness, or conditions that may impede or prohibit participation and are not currently pregnant
Who cannot join
- Capillary glucose less than 120
- Fasting glucose less than 100 mg/dL or greater than 125 mg/dL OR 2 hour post-load glucose less than 140 mg/dL or greater than 199 mg/dL
- Age less than 25 years
- BMI less than 22 kg/m2
- Pregnancy
- History of heart disease or diabetes (other than gestational diabetes)
Show all 9Show fewer
- Current functional difficulties
- Severe lung disease or cancer
- Failure to pass cardiovascular stress test
Trial locations and contacts
1 site in 1 country.
About this study
The South Asian Community, people with origins in India, Pakistan, Bangladesh, Maldives, Nepal, Sri Lanka, or Bhutan, are more likely to get diabetes, get diabetes at younger ages, and do worse health-wise once they have diabetes than the general population. This study will test the feasibility and community acceptability of a culturally appropriate lifestyle intervention for the prevention of diabetes in the South Asian community. The outcomes of this project could be used to plan larger interventions to prevent diabetes in South Asians, a rapidly growing segment of the US population.
- Being tested
- Lifestyle Intervention Classes
- Keywords
- diabetes, obesity, pre-diabetes, South Asian
- Medical subject headings
- Diabetes Mellitus, Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Intervention ClassesBehavioural
Also called South Asian Health and Prevention Education (SHAPE)
The intervention will be based on the Diabetes Prevention Program but tailored to the needs of the community based on feedback gathered in focus groups. Classes will be group-based and will use a variety of teaching techniques and group-based work to teach participants about behavior change, diet, and physical activity. Participant will be required to attend one group exercise class per week based on traditional Indian dances and other culturally appropriate activities. In order to reach their weekly exercise goal of 150 minutes or more per week, participants will also be able to attend an additional group exercise class, an organized group walk, do a culturally-tailored work out video created by the study staff, and/or exercise on their own.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Diet and Exercise) | Experimental | The lifestyle intervention will include a 16-week intervention period, followed by an 8 week, less intensive maintenance period. Receives: Behavioral: Lifestyle Intervention Classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Measured: 24 weeks (16 week intervention, 8 week maintenance)
Secondary outcomes (8)
percent body fat
Measured: 24 weeks (16 week intervention, 8 week maintenance)
body mass index
Measured: 24 weeks (16 week intervention, 8 week maintenance)
waist-to-hip ratio
Measured: 24 weeks (16 week intervention, 8 week maintenance)
fasting glucose
Measured: 24 weeks (16 week intervention, 8 week maintenance)
blood pressure
Measured: 24 weeks (16 week intervention, 8 week maintenance)
plasma lipids
Measured: 24 weeks (16 week intervention, 8 week maintenance)
self-reported physical activity
Measured: 24 weeks (16 week intervention, 8 week maintenance)
Percent of Total Calories from Fat
Measured: 24 weeks (16 week intervention, 8 week maintenance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Venkat Narayan, Emory University
- Investigators
- Venkat Narayan, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084928
- Sponsor's protocol ID
- IRB00035893
- Other IDs
- 1R34DK081723-01A1
- Acronym
- SHAPE
- Status last verified
- Sep 2013
- First submitted
- 1 Mar 2010
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians
- ClinicalTrials.gov ID
- NCT01084928
- Acronym / sponsor ID
- SHAPE / IRB00035893
- Keywords
- diabetes, obesity, pre-diabetes, South Asian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Mar 2010 (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 South Asian Community, people with origins in India, Pakistan, Bangladesh, Maldives, Nepal, Sri Lanka, or Bhutan, are more likely to get diabetes, get diabetes at younger ages, and do worse health-wise once they have diabetes than the general population. This study will test the feasibility and community acceptability of a culturally appropriate lifestyle intervention for the prevention of diabetes in the South Asian community. The outcomes of this project could be used to plan larger interventions to prevent diabetes in South Asians, a rapidly growing segment of the US population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Diet and Exercise) | Experimental | Behavioral: Lifestyle Intervention ClassesThe lifestyle intervention will include a 16-week intervention period, followed by an 8 week, less intensive maintenance period. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-identified as being of South Asian origin
- Live in or near Atlanta, Georgia
- BMI greater than 22 kg/m2 calculated from standardized weight and height measurements (a BMI of greater than 22 kg/m2 is indicative of overweight in the South Asian population)
- A confirmed age greater than or equal to 25 determined by checking a valid photo identification (driver's license, passport, etc.)
- No prior diabetes diagnosis (physician diagnosis or on diabetes medication)
Key exclusion criteria (9 listed)
- Capillary glucose less than 120
- Fasting glucose less than 100 mg/dL or greater than 125 mg/dL OR 2 hour post-load glucose less than 140 mg/dL or greater than 199 mg/dL
- Age less than 25 years
- BMI less than 22 kg/m2
- Pregnancy
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 |
|---|---|---|
| Lifestyle Intervention ClassesAlso: South Asian Health and Prevention Education (SHAPE)The intervention will be based on the Diabetes Prevention Program but tailored to the needs of the community based on feedback gathered in focus groups. Classes will be group-based and will use a variety of teaching techniques and group-based work to teach participants about behavior change, diet, and physical activity. Participant will be required to attend one group exercise class per week based on traditional Indian dances and other culturally appropriate activities. In order to reach their weekly exercise goal of 150 minutes or more per week, participants will also be able to attend an additional group exercise class, an organized group walk, do a culturally-tailored work out video created by the study staff, and/or exercise on their own. | Behavioural | Intervention Arm (Diet and Exercise) |
Primary outcome
body weight
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
8 secondary outcomes
percent body fat
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
body mass index
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
waist-to-hip ratio
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
fasting glucose
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
blood pressure
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
plasma lipids
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
self-reported physical activity
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
Percent of Total Calories from Fat
Time frame: 24 weeks (16 week intervention, 8 week maintenance)
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 Sep 2013.
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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.
Venkat Narayan, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention Classes in people with Diabetes and Obesity, run by Emory University 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 8 inclusion and 9 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 Sep 2013. 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?
body weight (time frame: 24 weeks (16 week intervention, 8 week maintenance)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2013.