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| ID | Type | Description | Link |
|---|---|---|---|
| 14CRP19560008 | Other Grant/Funding Number | American Heart Association |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - PilAm Go4Health Program | 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. |
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| Active control - pedometer only | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percent Change in Weight (kg) From Baseline and 3 Months |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda S Bender, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco / Daly City Communities | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30291068 | Derived | 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. | |
| 27608829 | Derived | 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. |
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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.
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.
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.
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During the 2-week run-in, eligible participants are asked to wear Fitbit pedometer every day for 10 hours/day, take photos with their smart phone of each meal for 3 consecutive days, and email these photos to research study email.
Those who pass the physical exam, serum lab test, and run-in period are then randomized to one of two study groups.
All potential participants are invited to complete a pre-telephone screening. Those who pass the pre-telephone screening are potentially eligible to participate in the study and invited to attend a screening baseline visit where they are asked to complete a physical exam, serum blood tests, and a 2 week run-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group - Start With PilAm Go4Health Intervention | In the first 3 months intervention group start PilAm Go4Health lifestyle intervention. After initial 3-months participants will transition to a 3-month maintenance phase to maintain weight loss and learned lifestyle behaviors on their own. Group will complete the study at 6 months. PilAm Go4Health Weight-loss Program: This is a 3-month lifestyle intervention promoting weight loss through physical activity and health diet using a mobile health app, pedometer to track daily step-counts, and social networking (in-person and Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on oral meds. Subjects will be asked: 1) log daily calorie/food intake and weekly wt. in mobile app diary and 2) wear a pedometer for 10hrs/day to monitor steps |
| FG001 | Active Wait-list Control Group - Start With Pedometer Only | 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: 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Start With PilAm Go4Health Program | Baseline to 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: 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 physical activity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Total number of enrolled participants in each arm who completed 6-month program divided by the total number of enrolled participants in each arm. Goal is to retain 80% of participants enrolled in each arm. | Posted | Number | percentage of participants retained | Baseline to 6-months | participants | participants |
|
13 months (Dec 2014 through Dec 2015)
This study complied with the same clinicaltrials.gov definition for adverse event and/or serious adverse event. At each participant's schedule research office visit, an adverse event questionnaire was completed by the research staff to assess if any participant adverse events and/or serious adverse events had occurred since the previous research office visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - PilAm Go4Health Program | Baseline to 3 months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention. The intervention 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: 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 |
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Due to the study's small sample size and sample recruitment to one geographical region, study results cannot be generalized to other populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Sarmiento Bender, PhD, RN | University of California San Francisco | 415 502 5668 | melinda.bender@ucsf.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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statistician has been masked from any subjects' personal and confidential information
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| 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 |
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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 |
| Change in Waist Circumference | Change in waist circumference over time within groups | baseline to 3 months |
| BG001 | Start With Pedometer Only | 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: 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Active Control - Pedometer Only | This group start the first 3-months with a pedometer only. After 3 months, this Active Control transitions to receive the PilAm Go4Health lifestyle intervention for the second 3 month and completes the study at the end of 6 months 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). |
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| 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 | English-speaking Filipino Americans adults 18 years or older with overweight and Type 2 diabetes were randomized in a 1:1 ratio to either the intervention or active control group. | Posted | Mean | 95% Confidence Interval | kilogram | Baseline to 3 months |
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| 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. | Filipino American adults 18 years or older with overweight and Type 2 diabetes were randomized in a 1:1 ratio to either the Intervention or the Active Control group. | Posted | Mean | 95% Confidence Interval | percent change | Baseline to 3 months |
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| Secondary | Change in Waist Circumference | Change in waist circumference over time within groups | Multilevel regression used to analyze the within group change for waist circumference and cross-level interaction for between group change over time. | Posted | Mean | 95% Confidence Interval | centimeter | baseline to 3 months |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Active Control - Pedometer Only | 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: 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). | 0 | 23 | 0 | 23 | 0 | 23 |
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| D004700 | Endocrine System Diseases |
| D001519 | Behavior |