South Asian Healthy Lifestyle Initiative (SAHELI)
Status: | Recruiting |
---|---|
Conditions: | Peripheral Vascular Disease |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 6/6/2018 |
Start Date: | March 1, 2018 |
End Date: | May 31, 2021 |
Contact: | Swapna Dave, MPH,MBBS |
Email: | swapna-dave@northwestern.edu |
Phone: | 3125036995 |
Community Translation of the South Asian Healthy Lifestyle Intervention
Research show that South Asians (SA) have a high burden of Cardio Vascular Disease (CVD) risk
factors of which, poor diet and physical inactivity remain the major lifestyle risk factors
in SA. Intensive diet and physical activity behavioral interventions have been shown to yield
improvements across a variety of intermediate cardiovascular health outcomes (blood pressure,
cholesterol, glycated hemoglobin, weight) in persons with CVD risk factors and are
recommended by national guidelines. However, the investigators prior research found that
existing interventions are not reaching SA. First, the usual framing of behavioral risk
factor interventions in terms of the biomedical model of CVD is mismatched to SA explanatory
models, which emphasize psychosocial causes of CVD. Next, few interventions are tailored to
the sociocultural patterns shared by much of the SA community. Interventions that address the
individual and shared sociocultural drivers of CVD risk are needed to maximize reach and
effectiveness in the high risk and rapidly growing SA population. The proposed study builds
on the strong foundation of the South Asian Healthy Lifestyle Initiative (SAHELI), which has
a 9-year history of using community-based participatory research to design and test
culturally tailored, community-based interventions to reduce CVD disparities in SA. To date,
SAHELI has engaged multi-sectoral partners, established relationships of trust, and defined
mutually beneficial goals. The investigators also culturally adapted the SAHELI lifestyle
intervention to (a) address the individual and sociocultural determinants of CVD risk in SA;
and (b) increase components of self-regulation (motivation, self-monitoring, goal setting)
that are most effective in eliciting diet and physical activity changes.Hence, the SAHELI
intervention integrates evidence-based behavior change techniques with the shared the
sociocultural processes salient to SA. A pilot study (n=63) established feasibility of the
SAHELI intervention, had a 100% retention rate, and reduced glycated hemoglobin and weight
among intervention participants compared to a control group. Based on this preliminary
evidence of efficacy and a process evaluation, the investigators modified select components
of the intervention for the proposed trial. Study team increased the intervention contact
hours, piloted additional diet and exercise content, and included family. The proposed study
will use a hybrid trial type 1 design to evaluate the clinical effectiveness and
implementation potential of the culturally tailored, community-based lifestyle intervention
in a larger, more generalizable at-risk SA population. Study team is uniquely positioned to
fill a critical gap in work (a) demonstrating the cultural adaptation of evidence-based
lifestyle interventions, and (b) evaluating the effectiveness of the SAHELI intervention in
reducing CVD risk in SA living in the U.S.
factors of which, poor diet and physical inactivity remain the major lifestyle risk factors
in SA. Intensive diet and physical activity behavioral interventions have been shown to yield
improvements across a variety of intermediate cardiovascular health outcomes (blood pressure,
cholesterol, glycated hemoglobin, weight) in persons with CVD risk factors and are
recommended by national guidelines. However, the investigators prior research found that
existing interventions are not reaching SA. First, the usual framing of behavioral risk
factor interventions in terms of the biomedical model of CVD is mismatched to SA explanatory
models, which emphasize psychosocial causes of CVD. Next, few interventions are tailored to
the sociocultural patterns shared by much of the SA community. Interventions that address the
individual and shared sociocultural drivers of CVD risk are needed to maximize reach and
effectiveness in the high risk and rapidly growing SA population. The proposed study builds
on the strong foundation of the South Asian Healthy Lifestyle Initiative (SAHELI), which has
a 9-year history of using community-based participatory research to design and test
culturally tailored, community-based interventions to reduce CVD disparities in SA. To date,
SAHELI has engaged multi-sectoral partners, established relationships of trust, and defined
mutually beneficial goals. The investigators also culturally adapted the SAHELI lifestyle
intervention to (a) address the individual and sociocultural determinants of CVD risk in SA;
and (b) increase components of self-regulation (motivation, self-monitoring, goal setting)
that are most effective in eliciting diet and physical activity changes.Hence, the SAHELI
intervention integrates evidence-based behavior change techniques with the shared the
sociocultural processes salient to SA. A pilot study (n=63) established feasibility of the
SAHELI intervention, had a 100% retention rate, and reduced glycated hemoglobin and weight
among intervention participants compared to a control group. Based on this preliminary
evidence of efficacy and a process evaluation, the investigators modified select components
of the intervention for the proposed trial. Study team increased the intervention contact
hours, piloted additional diet and exercise content, and included family. The proposed study
will use a hybrid trial type 1 design to evaluate the clinical effectiveness and
implementation potential of the culturally tailored, community-based lifestyle intervention
in a larger, more generalizable at-risk SA population. Study team is uniquely positioned to
fill a critical gap in work (a) demonstrating the cultural adaptation of evidence-based
lifestyle interventions, and (b) evaluating the effectiveness of the SAHELI intervention in
reducing CVD risk in SA living in the U.S.
Inclusion Criteria:
- South Asian adults (18-65 years)
- Living within the 22 square mile study area
- Ability to understand Hindi, Urdu, Gujarati or English. AND
Body Mass Index of 25 and over and a diagnosis by a doctor of high cholesterol or
pre-diabetes/Diabetes, or High blood pressure. OR Body Mass Index of 23 to 24.9 and one
clinical risk factors for Cardiovascular Disease (CVD) (CVD risk factors are: Hypertension
(Systolic blood pressure >130 or diastolic blood pressure > 80), abnormal cholesterol
(Total cholesterol ≥200, triglycerides >150),pre-diabetes (A1c between 5.7-6.4%), or
diabetes (A1c 6.5 to 10.9),
Exclusion Criteria:
- History of a CVD event (stroke or heart attack)
- Being on insulin
- Blood pressure ≥180/100 mmHg
- HbA1c ≥11% BMI ≥ 40
- Current pregnancy
- Being ≤ 12 months postpartum
- Any underlying diseases likely to limit lifespan and/or affects ability to exercise.
We found this trial at
1
site
303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Namratha Kandula, MD, MPH
Phone: 312-503-6995
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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