Obese, Overweight, Pre-diabetes
Conditions
Keywords
diabetes prevention, Filipinos, lifestyle intervention
Brief summary
Filipino Americans (FA) are the second largest (3.4 million) Asian group in the US. and have one of the highest prevalences of obesity and type 2 diabetes mellitus compared to non-Hispanic whites, African Americans and Hispanics. However, FA have been underrepresented in health related research, particularly in diabetes prevention. This proposed pilot study is the first clinical trial to assess preliminary estimates of the short-term effect of the novel social networking diabetes prevention program lifestyle intervention for this high-risk population.
Detailed description
Filipino Americans (FA) are the second largest (3.4 million) Asian group in the US, and the largest (1.5 million) in California, and have the highest prevalence of obesity and type 2 diabetes mellitus (T2DM) compared to non-Hispanic whites, African Americans and Hispanics. However, there has been little health related research among FA. Improving physical activity (PA) and diet can prevent or delay T2DM, as evidenced by the Diabetes Prevention Program (DPP) lifestyle intervention, resulting in reducing T2DM risks. However, implementing the DPP has been expensive and labor intensive. A more cost-effective approach may be the use of mobile technologies coupled with social networking. Filipinos (95%) are avid mobile phone users and the leading Facebook users. Thus, we propose to test a culturally competent mobile phone-based Diabetes Prevention Program lifestyle and social networking (in-person and virtual) intervention in a pilot 3-month randomized controlled trial (RCT) with a wait list active control design for 50 overweight FA at risk for developing type 2 diabetes.
Interventions
BEHAVIORALFilipinos Fit and Trim Weight Loss Program
This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
: 1) BMI for Asians \> 23 kg/m2, 2) Age \> 24 years, 3) Diabetes risk test score52 \> 5 points, fasting plasma glucose test between 100 - 125 mg/dl, HbA1c \> 5.6% or oral glucose tolerance test (OGTT) between 140-200 mg/dl, 4) physically inactive based on Brief Physical Activity Recall Questionnaire,53 5) no cognitive impairment based on the Mini-Cog test,54 and 7) English speaking. Only one member per household will be allowed to enroll in the study. A smart phone will be provided if necessary. \-
Exclusion criteria
1) Physician diagnosed diabetes and confirmed by clinical data (e.g. documentation of fasting blood glucose \>126 mg/dL or a positive OGTT), 2) HbA1C \> 7.0%, 3) Glucose metabolism associated disease (Cushing's syndrome, Acromegaly, and Pheochromocytoma currently under treatment, chronic pancreatitis), 4) Thyroid disease - sub-optimally treated, 5) Known medical conditions or other physical problems needing 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, asthma, chronic obstructive pulmonary disease, or uncontrolled hypertension), 6) Currently participating in a lifestyle modification program, 7) Planning a trip outside of the US during the 3-month study period, 8) Known eating disorder, 9) Planning to have gastric bypass surgery, 10) Taking antibiotics (including HIV-related agents), anti-tuberculosis agents (except tuberculosis prophylaxis)\], or prescription weight-loss drugs. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Who Completed the Study | Baseline to 6-months | at least 85% of participants enrolled complete the study program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change in Kilogram | Baseline to 3 months | Weight change in kilogram by group |
| Percent of Weight | Baseline to 3 months | Percent of weight change from baseline to 3-months by group |
| Change in Body Mass Index (BMI) | Baseline to 3 months | Change in body mass index per group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fit and Trim Group This groups will start with the Filipinos Fit and Trim Weight Loss Program mobile phone based (smartphone) intervention with social networking for 3 months, a pedometer/accelerometer, access to a study private Facebook virtual social networking group, and and 4 in-person intervention session with individually tailored goals for physical activity, diet, and weight. At 3months, the Fit and Trim group will transition to a maintenance phase for 3 months, receive one in-person session for maintenance support (at 4.5 months) and complete the study at month 6.
Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention uses a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino | 33 |
| Pedometer Only Group This group will start with the pedometer/accelerometer only to monitor/ track their physical activity step-counts for the initial 3 months. In addition, subjects will receive an educational materials on Hepatitis B and Tuberculosis. At 3 months pedometer only group will transition to receive the Filipinos Fit and Trim Weight Loss Program intervention (as previously described) for the next 3 months and complete the study at month 6.
Filipinos Fit and Trim Weight Loss Program: This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in st | 34 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | death in family | 1 | 0 |
| Overall Study | family emergency unable to commit | 2 | 0 |
| Overall Study | lack of time | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Pedometer Only Group | Total | Fit and Trim Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 64 Participants | 32 Participants |
| Age, Continuous | 42.1 years STANDARD_DEVIATION 12.1 | 41.8 years STANDARD_DEVIATION 11.8 | 41.3 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 67 Participants | 33 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 | 34 Participants | 67 Participants | 33 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 | 00 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 34 participants | 67 participants | 33 participants |
| Sex: Female, Male Female | 19 Participants | 35 Participants | 16 Participants |
| Sex: Female, Male Male | 15 Participants | 32 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 34 |
| other Total, other adverse events | 0 / 33 | 0 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 |
Outcome results
Primary
Count of Participants Who Completed the Study
at least 85% of participants enrolled complete the study program
Time frame: Baseline to 6-months
Population: Eligible participants enrolled and randomized = 67 ( Intervention group = 33 Control group =34). A Feasibility = at least 85% of all enrolled participant will have completed the study program.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fit and Trim Intervention Group | Count of Participants Who Completed the Study | 28 Participants |
| Active Control Group | Count of Participants Who Completed the Study | 33 Participants |
Secondary
Change in Body Mass Index (BMI)
Change in body mass index per group
Time frame: Baseline to 3 months
Population: Overweight/obese English-speaking Filipino American adults, were randomized either to the Intervention group (received a combination of mobile app, social media and in-person diabetes prevention intervention) or the active control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fit and Trim Intervention Group | Change in Body Mass Index (BMI) | -1.27 kg/m^2 | Standard Deviation 1.29 |
| Active Control Group | Change in Body Mass Index (BMI) | -0.33 kg/m^2 | Standard Deviation 0.95 |
Comparison: Hypothesis: the intervention group will have a statistically greater reduction in BMI compared to the control from baseline to 3 monthsp-value: 0.002ANOVA
Secondary
Percent of Weight
Percent of weight change from baseline to 3-months by group
Time frame: Baseline to 3 months
Population: Overweight/obese English-speaking Filipino American adults were randomized either to the Intervention group or the active control.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fit and Trim Intervention Group | Percent of Weight | -4.33 percent of weight | Standard Deviation 4.26 |
| Active Control Group | Percent of Weight | -1.02 percent of weight | Standard Deviation 3.14 |
Comparison: Hypothesis: the intervention group will have a statistically greater reduction in percent weight compared to the control from baseline to 3-monthsp-value: 0.001ANOVA
Secondary
Weight Change in Kilogram
Weight change in kilogram by group
Time frame: Baseline to 3 months
Population: Overweight/obese English-speaking Filipino American adults were randomized in a 1:1 ratio either to the intervention group or active control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fit and Trim Intervention Group | Weight Change in Kilogram | -3.4 kilograms | Standard Deviation 3.6 |
| Active Control Group | Weight Change in Kilogram | -0.9 kilograms | Standard Deviation 2.5 |
Comparison: Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the control from baseline to 3-monthsp-value: 0.003ANOVA