Clinical trial NCT02290184: PilAm Go4Health Weight Loss Program to Prevent Heart Disease
Official title: Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: Type 2 diabetes
cardiovascular disease prevention
weight loss lifestyle intervention
physical activity
diet
Filipinos
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility for Participant Enrollment and Retention
timeFrame: Baseline to 6-months
Secondary outcomes:
measure: Weight Change in Kilograms
timeFrame: Baseline to 3 months
measure: Percent Change in Weight (kg) From Baseline and 3 Months
timeFrame: Baseline to 3 months
measure: Change in Waist Circumference
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco / Daly City Communities
state: California
Study officials:
affiliation: University of California, San Francisco
name: Melinda S Bender, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bender MS, Cooper BA, Park LG, Padash S, Arai S. A Feasible and Efficacious Mobile-Phone Based Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Randomized Controlled Trial. JMIR Diabetes. 2017 Dec 12;2(2):e30. doi: 10.2196/diabetes.8156.
citation: Bender MS, Santos GM, Villanueva C, Arai S. Development of a Mobile Phone-Based Weight Loss Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Protocol and Early Results From the PilAm Go4Health Randomized Controlled Trial. JMIR Res Protoc. 2016 Sep 8;5(3):e178. doi: 10.2196/resprot.5836.