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Completed

NCT Number: NCT02290184

PilAm Go4Health Weight Loss Program to Prevent Heart Disease

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco / Daly City Communities

San Francisco, California, 94115, United States

About this study

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:

  • To assess feasibility and acceptability of the culturally appropriate PilAm Go4Health Weight Loss Program
  • To obtain preliminary estimates of the effect of the intervention on weight
  • To conduct post-program process evaluations too improve the intervention relevancy for the target population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PilAm Go4Health Weight-loss Program

Behavioral

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).

Other names: PilAm Go4Health Program

Active Control

Behavioral

This is a 3-month active control using a pedometer only without any education related to wt loss, physical activity, health eating, or tracking healthy behaviors

Other names: pedometer only

Primary outcomes

  1. 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

  1. Weight Change in Kilograms

    Time frame: Baseline to 3 months

    weight change in kilograms over a 3 month period. Intervention group will have a significantly greater reduction in weight change compared to the active control from baseline to 3-months

  2. Percent Change in Weight (kg) From Baseline and 3 Months

    Time frame: Baseline to 3 months

    100 x change in weight (kg) at 3 months divided by weight (kg) at baseline. Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months.

  3. Change in Waist Circumference

    Time frame: baseline to 3 months

    Change in waist circumference over time within groups

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 13, 2014
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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