Fit and Trim for Diabetes Prevention
Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT02278939
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
67
1
2
27.9
2.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Filipinos Fit and Trim Weight Loss for Diabetes Prevention Program
Study Start Date
:
Nov 1, 2014
Actual Primary Completion Date
:
Jul 1, 2016
Actual Study Completion Date
:
Feb 28, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: 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.
Other Names:
|
| Active Comparator: 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 the 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. |
Behavioral: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Count of Participants Who Completed the Study [Baseline to 6-months]
at least 85% of participants enrolled complete the study program
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
24 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts 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.
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Francisco / Daly City Communities | San Francisco | California | United States | 94118 |
Sponsors and Collaborators
- University of California, San Francisco
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Melinda S Bender, PhD, RN, University of California, San Francisco
- Principal Investigator: Yoshimi Fukuoka, PhD, RN, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Melinda Bender,
Assistant Professor,
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02278939
Other Study ID Numbers:
- 14-13100
- 1R34DK102100-01
First Posted:
Oct 30, 2014
Last Update Posted:
Sep 28, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Melinda Bender,
Assistant Professor,
University of California, San Francisco
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Fit and Trim Group | Pedometer Only Group |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Period Title: Overall Study | ||
| STARTED | 33 | 34 |
| COMPLETED | 28 | 33 |
| NOT COMPLETED | 5 | 1 |
Baseline Characteristics
| Arm/Group Title | Fit and Trim Group | Pedometer Only Group | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 of all reporting groups |
| Overall Participants | 33 | 34 | 67 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
32
97%
|
32
94.1%
|
64
95.5%
|
| >=65 years |
1
3%
|
2
5.9%
|
3
4.5%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
41.3
(12.1)
|
42.1
(12.1)
|
41.8
(11.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
48.5%
|
19
55.9%
|
35
52.2%
|
| Male |
17
51.5%
|
15
44.1%
|
32
47.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
33
100%
|
34
100%
|
67
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
33
100%
|
34
100%
|
67
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
00
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
33
100%
|
34
100%
|
67
100%
|
Outcome Measures
| Title | Count of Participants Who Completed the Study |
|---|---|
| Description | at least 85% of participants enrolled complete the study program |
| Time Frame | Baseline to 6-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Fit and Trim Intervention Group | Active Control Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 33 | 34 |
| Count of Participants [Participants] |
28
84.8%
|
33
97.1%
|
| Title | Weight Change in Kilogram |
|---|---|
| Description | Weight change in kilogram by group |
| Time Frame | Baseline to 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overweight/obese English-speaking Filipino American adults were randomized in a 1:1 ratio either to the intervention group or active control group. |
| Arm/Group Title | Fit and Trim Intervention Group | Active Control Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 28 | 33 |
| Mean (Standard Deviation) [kilograms] |
-3.4
(3.6)
|
-0.9
(2.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fit and Trim Intervention Group, Active Control Group |
|---|---|---|
| Comments | Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the control from baseline to 3-months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes | |
| Method | ANOVA | |
| Comments | ||
| Title | Percent of Weight |
|---|---|
| Description | Percent of weight change from baseline to 3-months by group |
| Time Frame | Baseline to 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overweight/obese English-speaking Filipino American adults were randomized either to the Intervention group or the active control. |
| Arm/Group Title | Fit and Trim Intervention Group | Active Control Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 28 | 33 |
| Mean (Standard Deviation) [percent of weight] |
-4.33
(4.26)
|
-1.02
(3.14)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fit and Trim Intervention Group, Active Control Group |
|---|---|---|
| Comments | Hypothesis: the intervention group will have a statistically greater reduction in percent weight compared to the control from baseline to 3-months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .001 |
| Comments | This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes | |
| Method | ANOVA | |
| Comments | ||
| Title | Change in Body Mass Index (BMI) |
|---|---|
| Description | Change in body mass index per group |
| Time Frame | Baseline to 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Fit and Trim Intervention Group | Active Control Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 28 | 33 |
| Mean (Standard Deviation) [kg/m^2] |
-1.27
(1.29)
|
-0.33
(.95)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fit and Trim Intervention Group, Active Control Group |
|---|---|---|
| Comments | Hypothesis: the intervention group will have a statistically greater reduction in BMI compared to the control from baseline to 3 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .002 |
| Comments | This was an intention to treat analysis using the Tukey-Kramer adjustment to account for differences in group sample sizes | |
| Method | ANOVA | |
| Comments | ||
Adverse Events
| Time Frame | 1.5 years (Dec 2014 through June 2016) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | This study complied with the same clinicaltrials.gov definition for adverse event and/or serious adverse event. At each participant's scheduled research office visit an adverse event questionnaire was completed by the research staff to assess if any participant adverse events and/or serious adverse event had occurred since the previous research office visit. | |||
| Arm/Group Title | Fit and Trim Group | Pedometer Only Group | ||
| Arm/Group Description | This groups immediately starts Filipinos Fit and Trim Weight Loss Program mobile phone intervention with social networking for the first 3 months, At 3months, the Fit and Trim group transitions to a maintenance phase for another 3 months, and completes 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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months. | This group starts with a Fitbit pedometer/accelerometer only for the initial 3 months. At 3 months the pedometer only group transitions to receive the Filipinos Fit and Trim Weight Loss Program intervention ) for the next 3 months and completes 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 step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months. | ||
All Cause Mortality |
||||
| Fit and Trim Group | Pedometer Only Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/34 (0%) | ||
Serious Adverse Events |
||||
| Fit and Trim Group | Pedometer Only Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/34 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Fit and Trim Group | Pedometer Only Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/34 (0%) | ||
Limitations/Caveats
Due to the overall small sample size (n=67) and recruitment restricted to one geographical region, study results cannot be generalized to other populations.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Melinda Sarmiento Bender and Dr. Yoshimi Fukuoka |
|---|---|
| Organization | University of California San Francisco, School of Nursing |
| Phone | (415) 514-3151 |
| melinda.bender@ucsf.edu; yoshimi.fukuoka@ucsf.edu |
Responsible Party:
Melinda Bender,
Assistant Professor,
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02278939
Other Study ID Numbers:
- 14-13100
- 1R34DK102100-01
First Posted:
Oct 30, 2014
Last Update Posted:
Sep 28, 2018
Last Verified:
Aug 1, 2018