Trial Outcomes & Findings for PilAm Go4Health Weight Loss Program to Prevent Heart Disease (NCT NCT02290184)
NCT ID: NCT02290184
Last Updated: 2019-04-08
Results Overview
Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline to 6-months
Results posted on
2019-04-08
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
3-month Follow-up
|
22
|
23
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PilAm Go4Health Weight Loss Program to Prevent Heart Disease
Baseline characteristics by cohort
| Measure |
Start With PilAm Go4Health Program
n=22 Participants
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
|
Start With Pedometer Only
n=23 Participants
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).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6-monthsPopulation: 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.
Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm
Outcome measures
| Measure |
Intervention / PilAm Go4Health Program
n=22 Participants
In the first 3 months the Intervention group starts with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months the Intervention group transitions to a 3-month maintenance phase and continues physical activity and healthy eating behaviors learned in the PilAm Go4Health lifestyle intervention and then complete 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).
|
Active Control - Pedometer Only
n=23 Participants
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).
|
|---|---|---|
|
Feasibility for Participant Enrollment and Retention
|
22 percentage of participants retained
|
23 percentage of participants retained
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: 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.
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
Outcome measures
| Measure |
Intervention / PilAm Go4Health Program
n=22 Participants
In the first 3 months the Intervention group starts with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months the Intervention group transitions to a 3-month maintenance phase and continues physical activity and healthy eating behaviors learned in the PilAm Go4Health lifestyle intervention and then complete 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).
|
Active Control - Pedometer Only
n=23 Participants
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).
|
|---|---|---|
|
Weight Change in Kilograms
|
-2.1 kilogram
Interval -2.9 to -1.4
|
-.12 kilogram
Interval -0.72 to 0.59
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention / PilAm Go4Health Program
n=22 Participants
In the first 3 months the Intervention group starts with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months the Intervention group transitions to a 3-month maintenance phase and continues physical activity and healthy eating behaviors learned in the PilAm Go4Health lifestyle intervention and then complete 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).
|
Active Control - Pedometer Only
n=23 Participants
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).
|
|---|---|---|
|
Percent Change in Weight (kg) From Baseline and 3 Months
|
-2.9 percent change
Interval -3.9 to -2.0
|
-.28 percent change
Interval -1.0 to 0.56
|
SECONDARY outcome
Timeframe: baseline to 3 monthsPopulation: Multilevel regression used to analyze the within group change for waist circumference and cross-level interaction for between group change over time.
Change in waist circumference over time within groups
Outcome measures
| Measure |
Intervention / PilAm Go4Health Program
n=22 Participants
In the first 3 months the Intervention group starts with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months the Intervention group transitions to a 3-month maintenance phase and continues physical activity and healthy eating behaviors learned in the PilAm Go4Health lifestyle intervention and then complete 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).
|
Active Control - Pedometer Only
n=23 Participants
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).
|
|---|---|---|
|
Change in Waist Circumference
|
-2.5 centimeter
Interval -3.83 to -1.4
|
-0.16 centimeter
Interval -1.1 to 1.5
|
Adverse Events
Intervention - PilAm Go4Health Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control - Pedometer Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melinda Sarmiento Bender, PhD, RN
University of California San Francisco
Phone: 415 502 5668
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place