Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type2 Diabetes
- Sponsor
- University of California, San Francisco
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Feasibility for Participant Enrollment and Retention
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a pilot randomized controlled trial intervention to improve lifestyle behaviors (physical activity and health diet) for Filipino Americans with type 2 diabetes on metformin. If the PilAm Go4Health intervention demonstrates potential efficacy, it may identify effective intervention strategies to significantly reduce risks for heart disease risks (i.e., metabolic syndrome) in Filipino Americans.
Detailed Description
Filipino Americans are the second largest Asian population and fastest growing racial group in the United States. They have one of the highest rates of insulin resistance (type 2 diabetes = T2DM) and central obesity (fat distributions primarily in the abdominal region). T2DM and central obesity are two of five major risk factors for metabolic syndrome that lead to cardiovascular disease and stroke. Key factors contributing to obesity and T2DM in Filipinos are their physical inactivity, and a diet high in fat and soda intake. However, there are very few research studies on improving health behaviors to reduce risks for metabolic syndrome in Filipino Americans. To help reduce the risk of developing metabolic syndrome in overweight/obese Filipino Americans with T2DM, the proposed project will test a culturally appropriate health behavior intervention program to reduce weight and waist circumference, through increasing physical activity, and lowering fat and sugar sweetened beverage intake. This intervention uses a mobile phone health app and social networking to encourage adherence to target health behaviors. The goals are to: 1. To assess feasibility and acceptability of the culturally appropriate PilAm Go4Health Weight Loss Program 2. To obtain preliminary estimates of the effect of the intervention on weight 3. To conduct post-program process evaluations too improve the intervention relevancy for the target population.
Investigators
Melinda Bender
Assistant Professor
University of California, San Francisco
Eligibility Criteria
Inclusion Criteria
- •Self-identified as Filipino
- •Age \> 18 years
- •BMI for Asians \> 23 kg/m2
- •Physician diagnosed T2DM diabetes confirmed by clinical data (e.g. documentation of fasting blood glucose \>126 mg/dL or a positive oral glucose tolerance test (OGTT) \> 200 mg/dl, HbA1c \> 6.5%)
- •On metformin for T2DM
- •waist circumference: men \> 40 inches, women \> 35 inches 6) Physically inactive - most leisure time spent without much physical activity 7) No cognitive impairment per the Mini-Cog test 8) has a mobile smart phone (iPhone 4s or above, or android phone) 9) English speaking. Only one member per household allowed to enroll in the study.
Exclusion Criteria
- •Uncontrolled T2DM
- •Glucose metabolism associated disease (Cushing's syndrome, Acromegaly, and Pheochromocytoma currently under treatment, chronic pancreatitis), 2) Thyroid disease - sub-optimally treated
- •Known medical conditions or other physical problems needing a special exercise program (e.g., prior myocardial infarction, history of angioplasty or angina, admission for hospital evaluation of chest pain, use of nitroglycerin for angina, chronic obstructive pulmonary disease, or uncontrolled hypertension)
- •Recent acute coronary syndrome, congestive heart failure
- •Currently participating in a lifestyle modification program
- •Planning a trip outside of the US during the 6-month study period
- •Known eating disorder
- •Planning a surgery in the next 7-months
- •Taking long-term antibiotics (including HIV-related agents), anti-tuberculosis agents (except isoniazid alone as prophylaxis), or prescription weight-loss drugs
Outcomes
Primary Outcomes
Feasibility for Participant Enrollment and Retention
Time Frame: Baseline to 6-months
Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm
Secondary Outcomes
- Change in Waist Circumference(baseline to 3 months)
- Weight Change in Kilograms(Baseline to 3 months)
- Percent Change in Weight (kg) From Baseline and 3 Months(Baseline to 3 months)