Overview

This trial is active, not recruiting.

Conditions insulin resistance,, metabolic syndrome, type 2 diabetes
Treatment pilam go4health weight-loss program
Sponsor University of California, San Francisco
Start date November 2014
End date June 2016
Trial size 45 participants
Trial identifier NCT02290184, 14-14158, 14CRP19560008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
pilam go4health weight-loss program PilAm Go4Health Program
This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts).
(Active Comparator)
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
pilam go4health weight-loss program PilAm Go4Health Program
This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts).

Primary Outcomes

Measure
Body mass index (BMI) and weight
time frame: 3 months

Secondary Outcomes

Measure
Insulin resistance
time frame: 3 months
feasibility and acceptability of a culturally appropriate PilAm Go4Health Weight-loss Program as measured by subject recruitment, engagement, adherence, and retention.
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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 smartphone (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 or revascularization, congested 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 INH alone as prophylaxis), or prescription weight-loss drugs

Additional Information

Official title Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease
Principal investigator Melinda S Bender, PhD
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, blood glucose levels (evaluating insulin resistance) 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, BMI, and insulin resistance 3. To conduct post-program process evaluations too improve the intervention relevancy for the target population.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.