Diabetes, Hyperlipidemia, Hypertension, Obesity, Pre-diabetes
Conditions
Keywords
South Asians, Diabetes, Physical Activity, Coronary Heart Disease, Lifestyle
Brief 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) 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.
Interventions
BEHAVIORALLifestyle Intervention
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.
OTHERPrint Health Education
Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Significant medical or psychiatric co-morbidities * Plans to move out of the area within 2 years * Family/household member enrolled in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity (Minutes/Week) | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
Community outreach
Participants by arm
| Arm | Count |
|---|---|
| Primary Care Referral and Print Health Education Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail. | 32 |
| Lifestyle Intervention Lifestyle Intervention: 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. | 31 |
| Total | 63 |
Baseline characteristics
| Characteristic | Lifestyle Intervention | Primary Care Referral and Print Health Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 32 Participants | 63 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 8 | 50 years STANDARD_DEVIATION 7 | 50 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 31 participants | 32 participants | 63 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
Change in Physical Activity (Minutes/Week)
Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.
Time frame: baseline and 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Care Referral and Print Health Education | Change in Physical Activity (Minutes/Week) | 4 min/week | Standard Error 14 |
| Lifestyle Intervention | Change in Physical Activity (Minutes/Week) | 10 min/week | Standard Error 15 |
Primary
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
Time frame: baseline and 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Care Referral and Print Health Education | Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake | 0.58 percentage of kilocalories | Standard Error 0.51 |
| Lifestyle Intervention | Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake | 0.37 percentage of kilocalories | Standard Error 0.52 |