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PilAm Go4Health Weight Loss Program to Prevent Heart Disease

Primary Purpose

Type2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PilAm Go4Health Weight-loss Program

Active Control

About this trial

This is an interventional prevention trial for Type2 Diabetes focused on measuring Type 2 diabetes, cardiovascular disease prevention, weight loss lifestyle intervention, physical activity, diet, Filipinos

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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:

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

Sites / Locations

San Francisco / Daly City Communities

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention - PilAm Go4Health Program

Active control - pedometer only

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Change in Waist Circumference

Change in waist circumference over time within groups

Full Information

NCT ID

NCT02290184

First Posted

November 8, 2014

Last Updated

April 3, 2019

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02290184

Brief Title

PilAm Go4Health Weight Loss Program to Prevent Heart Disease

Official Title

Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

November 1, 2014 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes

Keywords

Type 2 diabetes, cardiovascular disease prevention, weight loss lifestyle intervention, physical activity, diet, Filipinos

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

statistician has been masked from any subjects' personal and confidential information

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention - PilAm Go4Health Program

Arm Type

Experimental

Arm Description

Arm Title

Active control - pedometer only

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PilAm Go4Health Weight-loss Program

Other Intervention Name(s)

PilAm Go4Health Program

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Active Control

Other Intervention Name(s)

pedometer only

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility for Participant Enrollment and Retention

Description

Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm

Time Frame

Baseline to 6-months

Secondary Outcome Measure Information:

Title

Weight Change in Kilograms

Description

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

Time Frame

Baseline to 3 months

Title

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

Description

Time Frame

Baseline to 3 months

Title

Change in Waist Circumference

Description

Change in waist circumference over time within groups

Time Frame

baseline to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melinda S Bender, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco / Daly City Communities

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003. That data set will be made available to qualified investigators within one year after completion of our investigators' data analyses and publication of papers presenting the results of those analyses. Requests will be reviewed and acted on by the PI or in consultation with a UCSF representative. After approval, the PI will prepare the requested dataset. This dataset will be carefully screened to make certain that all identifying information has been removed, including information that could be combined so as to identify an individual. Data will be provided in comma separated variables (CSV) text format rather than a proprietary format either on a CD or through a password-protected download from our website.

IPD Sharing Time Frame

That data set will be made available to qualified investigators within one year after completion of our investigators' data analyses and publication of papers presenting the results of those analyses.

IPD Sharing Access Criteria

Data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.Requests will be reviewed and acted on by the PI or in consultation with a University of California San Francisco (UCSF) representative. After approval, the PI will prepare the requested dataset. This dataset will be carefully screened to make certain that all identifying information has been removed, including information that could be combined so as to identify an individual. Data will be provided in comma separated variables (CSV) text format rather than a proprietary format either on a computer disk (CD) or through a password-protected download from our website.

Citations:

PubMed Identifier

30291068

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. Erratum In: JMIR Diabetes. 2018 Dec 21;3(4):e12784.

Results Reference

derived

PubMed Identifier

27608829

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.

Results Reference

derived

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PilAm Go4Health Weight Loss Program to Prevent Heart Disease

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