ObesityNCT01647438
Translating a Heart Disease Lifestyle Intervention Into the Community
A study testing Lifestyle Intervention and Print Health Education in people with Obesity and Hyperlipidemia, run by Northwestern University at 2 sites in United States.
Trial summary
Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle intervention to improve the cardiovascular health of underserved South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan)… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hyperlipidemia, Hypertension
- What is being tested?
- Lifestyle Intervention and Print Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- South Asians between 30 and 60 years
- Have at least one CHD risk factor: obesity (body mass index > 25 kg/m2- cutoff for obesity in South Asians), hyperlipidemia, hypertension, pre-diabetes, or diabetes.
Who cannot join
- Inability to speak English, Hindi, or Urdu
- History of clinically evident CVD (e.g. heart attack, stroke)
- Pregnant, lactating, or planning to become pregnant during the study period
- Conditions that inhibit moderate intensity physical activity
- Systolic blood pressure ≥190 or diastolic blood pressure ≥105; Triglycerides ≥ 400
- Using insulin for diabetes
Show all 9Show fewer
- Significant medical or psychiatric co-morbidities
- Plans to move out of the area within 2 years
- Family/household member enrolled in study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
Metropolitan Asian Family Services
Chicago, Illinois, 60645
About this study
Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle intervention to improve the cardiovascular health of underserved South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be randomly assigned to either a group to receive heart disease prevention classes or to another group where they will receive written materials about heart disease prevention.
Read the detailed description
South Asian individuals were recruited from a community based organization in Chicago and randomly assigned to the print health education group or the SAHELI intervention.
- Conditions
- Obesity, Hyperlipidemia, Hypertension, Pre-diabetes, Diabetes
- Being tested
- Lifestyle Intervention, Print Health Education
- Keywords
- South Asians, Diabetes, Physical Activity, Coronary Heart Disease, Lifestyle
- Medical subject headings
- Obesity, Hyperlipidemias, Hypertension, Glucose Intolerance, Diabetes Mellitus, Motor Activity, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
Print Health EducationOther
Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
| Study group | Role | What they receive |
|---|---|---|
| Print Health Education | Other | Participants receive print health education materials Receives: Other: Print Health Education |
| Lifestyle Intervention | Experimental | Six weekly health education classes and phone counseling. Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity (Minutes/Week)
Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.
Measured: baseline and 6-months
Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake
Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months
Measured: baseline and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namratha Kandula, Northwestern University
- Investigators
- Namratha Kandula, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647438
- Sponsor's protocol ID
- R21HL113743-01
- Status last verified
- Oct 2015
- First submitted
- 19 Jul 2012
- Last updated
- 2 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jayaprakash M, Puri-Taneja A, Kandula NR, Bharucha H, Kumar S, Dave SS. Qualitative Process Evaluation of a Community-Based Culturally Tailored Lifestyle Intervention for Underserved South Asians. Health Promot Pract. 2016 Nov;17(6):802-813. doi: 10.1177/1524839916650165. Epub 2016 May 24.
PubMed 27225217Kandula NR, Dave S, De Chavez PJ, Bharucha H, Patel Y, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial. BMC Public Health. 2015 Oct 16;15:1064. doi: 10.1186/s12889-015-2401-2.
PubMed 26475629Kandula NR, Patel Y, Dave S, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: design and methods. Contemp Clin Trials. 2013 Nov;36(2):479-87. doi: 10.1016/j.cct.2013.09.007. Epub 2013 Sep 21.
PubMed 24060673
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating a Heart Disease Lifestyle Intervention Into the Community
- ClinicalTrials.gov ID
- NCT01647438
- Acronym / sponsor ID
- R21HL113743-01
- Conditions
- Obesity, Hyperlipidemia, Hypertension, Pre-diabetes, Diabetes
- Keywords
- South Asians, Diabetes, Physical Activity, Coronary Heart Disease, Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Posted 2 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle intervention to improve the cardiovascular health of underserved South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be randomly assigned to either a group to receive heart disease prevention classes or to another group where they will receive written materials about heart disease prevention.
Detailed description
South Asian individuals were recruited from a community based organization in Chicago and randomly assigned to the print health education group or the SAHELI intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Print Health Education | Other | Other: Print Health EducationParticipants receive print health education materials |
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionSix weekly health education classes and phone counseling. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- South Asians between 30 and 60 years
- Have at least one CHD risk factor: obesity (body mass index > 25 kg/m2- cutoff for obesity in South Asians), hyperlipidemia, hypertension, pre-diabetes, or diabetes.
Key exclusion criteria (9 listed)
- Inability to speak English, Hindi, or Urdu
- History of clinically evident CVD (e.g. heart attack, stroke)
- Pregnant, lactating, or planning to become pregnant during the study period
- Conditions that inhibit moderate intensity physical activity
- Systolic blood pressure ≥190 or diastolic blood pressure ≥105; Triglycerides ≥ 400
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 InterventionParticipants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives. | Behavioural | Lifestyle Intervention |
| Print Health EducationParticipants will receive primary care referrals and print health education material about heart disease prevention in the mail. | Other | Print Health Education |
Primary outcome
Change in Physical Activity (Minutes/Week)
Time frame: baseline and 6-months
Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.
Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake
Time frame: baseline and 6-months
Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27225217Jayaprakash M, Puri-Taneja A, Kandula NR, Bharucha H, Kumar S, Dave SS. Qualitative Process Evaluation of a Community-Based Culturally Tailored Lifestyle Intervention for Underserved South Asians. Health Promot Pract. 2016 Nov;17(6):802-813. doi: 10.1177/1524839916650165. Epub 2016 May 24.
- Derived from this study: PubMed 26475629Kandula NR, Dave S, De Chavez PJ, Bharucha H, Patel Y, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial. BMC Public Health. 2015 Oct 16;15:1064. doi: 10.1186/s12889-015-2401-2.
- Derived from this study: PubMed 24060673Kandula NR, Patel Y, Dave S, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: design and methods. Contemp Clin Trials. 2013 Nov;36(2):479-87. doi: 10.1016/j.cct.2013.09.007. Epub 2013 Sep 21.
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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.
Namratha Kandula, MD, MPH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention and Print Health Education in people with Obesity and Hyperlipidemia, run by Northwestern University at 2 sites 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 2 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Physical Activity (Minutes/Week) (time frame: baseline and 6-months). 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 NCT01647438, which also lists 3 linked publications.
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 2 Nov 2015.