N/A
N=45
PilAm Go4Health Weight Loss Program to Prevent Heart Disease
Type2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02290184 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Feasibility for Participant Enrollment and Retention — 22; 23 percentage of participants retained
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PilAm Go4Health Weight-loss Program (Behavioral); Active Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility for Participant Enrollment and Retention |
22; 23 | — |
| SECONDARY Weight Change in Kilograms |
-2.1; -.12 | — |
| SECONDARY Percent Change in Weight (kg) From Baseline and 3 Months |
-2.9; -.28 | — |
| SECONDARY Change in Waist Circumference |
-2.5; -0.16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Self-identified as Filipino
- Age > 18 years
- BMI for Asians > 23 kg/m2
- 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%)
- On metformin for T2DM
- 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
- Uncontrolled T2DM
- Glucose metabolism associated disease (Cushing's syndrome, Acromegaly, and Pheochromocytoma currently under treatment, chronic pancreatitis), 2) Thyroid disease - sub-optimally treated
- 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)
- Recent acute coronary syndrome, congestive heart failure
- Currently participating in a lifestyle modification program
- Planning a trip outside of the US during the 6-month study period
- Known eating disorder
- Planning a surgery in the next 7-months
- Taking long-term antibiotics (including HIV-related agents), anti-tuberculosis agents (except isoniazid alone as prophylaxis), or prescription weight-loss drugs
Data sourced from ClinicalTrials.gov (NCT02290184). 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.