PilAm Go4Health Weight Loss Program to Prevent Heart Disease

University of California San Francisco (UCSF)

Status: Completed

Conditions: Type2 Diabetes

Treatments: Behavioral: PilAm Go4Health Weight-loss Program; Behavioral: Active Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02290184

14-14158

14CRP19560008 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Self-identified as Filipino
2. Age > 18 years
3. BMI for Asians > 23 kg/m2
4. 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%)
5. On metformin for T2DM

4. 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

1. Uncontrolled T2DM
2. Glucose metabolism associated disease (Cushing's syndrome, Acromegaly, and Pheochromocytoma currently under treatment, chronic pancreatitis), 2) Thyroid disease - sub-optimally treated
3. 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)
4. Recent acute coronary syndrome, congestive heart failure
5. Currently participating in a lifestyle modification program
6. Planning a trip outside of the US during the 6-month study period
7. Known eating disorder
8. Planning a surgery in the next 7-months
9. Taking long-term antibiotics (including HIV-related agents), anti-tuberculosis agents (except isoniazid alone as prophylaxis), or prescription weight-loss drugs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Intervention - PilAm Go4Health Program

Experimental group

Description:

In the first 3 months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months this group will transition to a 3-month maintenance phase where they will continue to maintain the physical activity and healthy eating behaviors learned in the PilAm Go4Health Weight-loss Program lifestyle intervention and will complete the study for a total of 6 months.

Treatment:

Behavioral: PilAm Go4Health Weight-loss Program

Active control - pedometer only

Active Comparator group

Description:

In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months

Treatment:

Behavioral: Active Control