Fit and Trim for Diabetes Prevention

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Filipinos Fit and Trim Weight Loss Program

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring diabetes prevention, Filipinos, lifestyle intervention

Eligibility Criteria

24 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

San Francisco / Daly City Communities

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fit and Trim group

Pedometer only group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Count of Participants Who Completed the Study

at least 85% of participants enrolled complete the study program

Secondary Outcome Measures

Weight Change in Kilogram

Weight change in kilogram by group

Percent of Weight

Percent of weight change from baseline to 3-months by group

Change in Body Mass Index (BMI)

Change in body mass index per group

Full Information

NCT ID

NCT02278939

First Posted

October 28, 2014

Last Updated

August 31, 2018

Sponsor

University of California, San Francisco

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT02278939

Brief Title

Fit and Trim for Diabetes Prevention

Official Title

Filipinos Fit and Trim Weight Loss for Diabetes Prevention Program

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Francisco

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes, Overweight, Obese

Keywords

diabetes prevention, Filipinos, lifestyle intervention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fit and Trim group

Arm Type

Experimental

Arm 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.

Arm Title

Pedometer only group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Filipinos Fit and Trim Weight Loss Program

Other Intervention Name(s)

Fit and Trim

Intervention Description

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.

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

Title

Weight Change in Kilogram

Description

Weight change in kilogram by group

Time Frame

Baseline to 3 months

Title

Percent of Weight

Description

Percent of weight change from baseline to 3-months by group

Time Frame

Baseline to 3 months

Title

Change in Body Mass Index (BMI)

Description

Change in body mass index per group

Time Frame

Baseline to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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. - 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melinda S Bender, PhD, RN

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yoshimi Fukuoka, PhD, RN

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco / Daly City Communities

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003. That data set will be made available to qualified investigators within one year after completion of our investigators' data analyses and publication of papers presenting the results of those analyses. Requests will be reviewed and acted on by the PI or in consultation with a UCSF representative. After approval, the PI will prepare the requested dataset. This dataset will be carefully screened to make certain that all identifying information has been removed, including information that could be combined so as to identify an individual. Data will be provided in comma separated variables (CSV) text format rather than a proprietary format either on a CD or through a password-protected download from our website.

IPD Sharing Time Frame

That data set will be made available to qualified investigators within one year after completion of our investigators' data analyses and publication of papers presenting the results of those analyses.

IPD Sharing Access Criteria

Data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003. Requests will be reviewed and acted on by the PI or in consultation with a UCSF representative. After approval, the PI will prepare the requested dataset. This dataset will be carefully screened to make certain that all identifying information has been removed, including information that could be combined so as to identify an individual. Data will be provided in comma separated variables (CSV) text format rather than a proprietary format either on a CD or through a password-protected download from our website.

Citations:

PubMed Identifier

30294699

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.

Results Reference

derived

Pre-diabetes, Overweight, Obese

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial