Type2 Diabetes
Conditions
Keywords
Type 2 diabetes, cardiovascular disease prevention, weight loss lifestyle intervention, physical activity, diet, Filipinos
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: 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.
Interventions
BEHAVIORALPilAm 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).
BEHAVIORALActive 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
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
statistician has been masked from any subjects' personal and confidential information
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility for Participant Enrollment and Retention | 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
| Measure | Time frame | Description |
|---|---|---|
| Weight Change in Kilograms | 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 |
| Percent Change in Weight (kg) From Baseline and 3 Months | 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. |
| Change in Waist Circumference | baseline to 3 months | Change in waist circumference over time within groups |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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). | 23 |
| Total | 45 |
Baseline characteristics
| Characteristic | Start With PilAm Go4Health Program | Start With Pedometer Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 23 Participants | 45 Participants |
| Age, Continuous | 57.4 years STANDARD_DEVIATION 9.8 | 57.7 years STANDARD_DEVIATION 10 | 57.6 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 23 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 22 Participants | 23 Participants | 45 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
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
Time frame: Baseline to 6-months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention / PilAm Go4Health Program | Feasibility for Participant Enrollment and Retention | 22 percentage of participants retained |
| Active Control - Pedometer Only | Feasibility for Participant Enrollment and Retention | 23 percentage of participants retained |
Secondary
Change in Waist Circumference
Change in waist circumference over time within groups
Time frame: baseline to 3 months
Population: Multilevel regression used to analyze the within group change for waist circumference and cross-level interaction for between group change over time.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention / PilAm Go4Health Program | Change in Waist Circumference | -2.5 centimeter |
| Active Control - Pedometer Only | Change in Waist Circumference | -0.16 centimeter |
Comparison: Hypothesis: Intervention group will have a significantly greater reduction in waist-circumference (cm) compared to the Active Control from baseline to 3-months95% CI: [-4.5, -0.91]
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.
Time frame: Baseline to 3 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention / PilAm Go4Health Program | Percent Change in Weight (kg) From Baseline and 3 Months | -2.9 percent change |
| Active Control - Pedometer Only | Percent Change in Weight (kg) From Baseline and 3 Months | -.28 percent change |
Comparison: Hypothesis: Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months0.05% CI: [-3.9, -1.4]
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
Time frame: Baseline to 3 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention / PilAm Go4Health Program | Weight Change in Kilograms | -2.1 kilogram |
| Active Control - Pedometer Only | Weight Change in Kilograms | -.12 kilogram |
Comparison: Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the active control from baseline to 3-months.0.05% CI: [-3, -1.1]