Clinical trial NCT02278939: Fit and Trim for Diabetes Prevention
Official title: Filipinos Fit and Trim Weight Loss for Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Overweight
Obese
Keywords: diabetes prevention
Filipinos
lifestyle intervention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-10-30
Enrollment: 67
Sex: ALL
Minimum age (years): 24
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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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Primary outcomes:
measure: Count of Participants Who Completed the Study
timeFrame: Baseline to 6-months
Secondary outcomes:
measure: Weight Change in Kilogram
timeFrame: Baseline to 3 months
measure: Percent of Weight
timeFrame: Baseline to 3 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco / Daly City Communities
state: California
Study officials:
affiliation: University of California, San Francisco
name: Melinda S Bender, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Yoshimi Fukuoka, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bender MS, Cooper BA, Flowers E, Ma R, Arai S. Filipinos Fit and Trim - A feasible and efficacious DPP-based intervention trial. Contemp Clin Trials Commun. 2018 Sep 20;12:76-84. doi: 10.1016/j.conctc.2018.09.004. eCollection 2018 Dec.