Trial Outcomes & Findings for Fit and Trim for Diabetes Prevention (NCT NCT02278939)
NCT ID: NCT02278939
Last Updated: 2018-09-28
Results Overview
at least 85% of participants enrolled complete the study program
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Baseline to 6-months
Results posted on
2018-09-28
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
|
Overall Study
COMPLETED
|
28
|
33
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
lack of time
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
death in family
|
1
|
0
|
|
Overall Study
family emergency unable to commit
|
2
|
0
|
Baseline Characteristics
Fit and Trim for Diabetes Prevention
Baseline characteristics by cohort
| Measure |
Fit and Trim Group
n=33 Participants
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
|
Pedometer Only Group
n=34 Participants
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
|
Total
n=67 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
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 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
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 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
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 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
|
00 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6-monthsPopulation: 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.
at least 85% of participants enrolled complete the study program
Outcome measures
| Measure |
Fit and Trim Intervention Group
n=33 Participants
This groups immediately starts the Filipinos Fit and Trim Weight Loss Program mobile phone based (smartphone) intervention with social networking for the initial 3 months. At 3months, the Fit and Trim group transitions to a 3-month maintenance phase and completes the study at the 6-month visit.
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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
|
Active Control Group
n=34 Participants
This group starts using the Fitbit accelerometer only to track physical activity step-counts for the initial 3 months. At the 3 month visit, the active control participants transition to receive the 3-month Filipinos Fit and Trim intervention and complete the study at their 6-month visit.
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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
|
|---|---|---|
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Count of Participants Who Completed the Study
|
28 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: Overweight/obese English-speaking Filipino American adults were randomized in a 1:1 ratio either to the intervention group or active control group.
Weight change in kilogram by group
Outcome measures
| Measure |
Fit and Trim Intervention Group
n=28 Participants
This groups immediately starts the Filipinos Fit and Trim Weight Loss Program mobile phone based (smartphone) intervention with social networking for the initial 3 months. At 3months, the Fit and Trim group transitions to a 3-month maintenance phase and completes the study at the 6-month visit.
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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
|
Active Control Group
n=33 Participants
This group starts using the Fitbit accelerometer only to track physical activity step-counts for the initial 3 months. At the 3 month visit, the active control participants transition to receive the 3-month Filipinos Fit and Trim intervention and complete the study at their 6-month visit.
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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
|
|---|---|---|
|
Weight Change in Kilogram
|
-3.4 kilograms
Standard Deviation 3.6
|
-0.9 kilograms
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: Overweight/obese English-speaking Filipino American adults were randomized either to the Intervention group or the active control.
Percent of weight change from baseline to 3-months by group
Outcome measures
| Measure |
Fit and Trim Intervention Group
n=28 Participants
This groups immediately starts the Filipinos Fit and Trim Weight Loss Program mobile phone based (smartphone) intervention with social networking for the initial 3 months. At 3months, the Fit and Trim group transitions to a 3-month maintenance phase and completes the study at the 6-month visit.
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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
|
Active Control Group
n=33 Participants
This group starts using the Fitbit accelerometer only to track physical activity step-counts for the initial 3 months. At the 3 month visit, the active control participants transition to receive the 3-month Filipinos Fit and Trim intervention and complete the study at their 6-month visit.
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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
|
|---|---|---|
|
Percent of Weight
|
-4.33 percent of weight
Standard Deviation 4.26
|
-1.02 percent of weight
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: 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.
Change in body mass index per group
Outcome measures
| Measure |
Fit and Trim Intervention Group
n=28 Participants
This groups immediately starts the Filipinos Fit and Trim Weight Loss Program mobile phone based (smartphone) intervention with social networking for the initial 3 months. At 3months, the Fit and Trim group transitions to a 3-month maintenance phase and completes the study at the 6-month visit.
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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
|
Active Control Group
n=33 Participants
This group starts using the Fitbit accelerometer only to track physical activity step-counts for the initial 3 months. At the 3 month visit, the active control participants transition to receive the 3-month Filipinos Fit and Trim intervention and complete the study at their 6-month visit.
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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-1.27 kg/m^2
Standard Deviation 1.29
|
-0.33 kg/m^2
Standard Deviation .95
|
Adverse Events
Fit and Trim Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pedometer Only Group
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
Dr. Melinda Sarmiento Bender and Dr. Yoshimi Fukuoka
University of California San Francisco, School of Nursing
Phone: (415) 514-3151
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place