Fit and Trim for Diabetes Prevention

Overweight Clinical Trial

Official title:

Filipinos Fit and Trim Weight Loss for Diabetes Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278939
• Other study ID #: 14-13100
• Secondary ID: 1R34DK102100-01
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: February 28, 2017

Study information

• Verified date: August 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 28, 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Obese
• Overweight
• Pre-diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	San Francisco / Daly City Communities	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of Participants Who Completed the Study	at least 85% of participants enrolled complete the study program	Baseline to 6-months
Secondary	Weight Change in Kilogram	Weight change in kilogram by group	Baseline to 3 months
Secondary	Percent of Weight	Percent of weight change from baseline to 3-months by group	Baseline to 3 months
Secondary	Change in Body Mass Index (BMI)	Change in body mass index per group	Baseline to 3 months