N/A
N=67
Fit and Trim for Diabetes Prevention
Pre-diabetes · Overweight · Obese
Bottom Line
View on ClinicalTrials.gov: NCT02278939 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Count of Participants Who Completed the Study — 28; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Filipinos Fit and Trim Weight Loss Program (Behavioral)
- Age
- Adult, Older Adult · 24+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants Who Completed the Study |
28; 33 | — |
| SECONDARY Weight Change in Kilogram |
-3.4; -0.9 | 0.003 sig |
| SECONDARY Percent of Weight |
-4.33; -1.02 | .001 sig |
| SECONDARY Change in Body Mass Index (BMI) |
-1.27; -0.33 | .002 sig |
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.
Eligibility Criteria
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.
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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.
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Data sourced from ClinicalTrials.gov (NCT02278939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.