PilAm Go4Health Weight Loss Program to Prevent Heart Disease

Type2 Diabetes Clinical Trial

Official title:

Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290184
• Other study ID #: 14-14158
• Secondary ID: 14CRP19560008
• Status: Completed
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: August 2017

Study information

• Verified date: April 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Heart Diseases
• Type2 Diabetes
• Weight Loss

Intervention

Behavioral:
• PilAm Go4Health Weight-loss 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 Control
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

Locations

Country	Name	City	State
United States	San Francisco / Daly City Communities	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility for Participant Enrollment and Retention	Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm	Baseline to 6-months
Secondary	Weight Change in Kilograms	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	Baseline to 3 months
Secondary	Percent Change in Weight (kg) From Baseline and 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.	Baseline to 3 months
Secondary	Change in Waist Circumference	Change in waist circumference over time within groups	baseline to 3 months