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Pre-diabetesNCT02278939

Fit and Trim for Diabetes Prevention

A study testing Filipinos Fit and Trim Weight Loss Program in people with Pre-diabetes and Overweight, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 24 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Pre-diabetes, Overweight, Obese
What is being tested?
Filipinos Fit and Trim Weight Loss Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteUnited States
Study dates
Nov 2014to 28 Feb 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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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Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Francisco / Daly City Communities

    San Francisco, California, 94118

Other trials in United States

About this study

Official title: Filipinos Fit and Trim Weight Loss for Diabetes Prevention Program

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.

Read the 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.

Being tested
Filipinos Fit and Trim Weight Loss Program
Keywords
diabetes prevention, Filipinos, lifestyle intervention
Medical subject headings
Glucose Intolerance, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Filipinos Fit and Trim Weight Loss ProgramBehavioural

    Also called Fit and Trim

    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.

Study groups in NCT02278939
Study groupRoleWhat they receive
Fit and Trim groupExperimentalThis 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.
Receives: Behavioral: Filipinos Fit and Trim Weight Loss Program
Pedometer only groupActive comparatorThis 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.
Receives: Behavioral: Filipinos Fit and Trim Weight Loss Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Count of Participants Who Completed the Study

    at least 85% of participants enrolled complete the study program

    Measured: Baseline to 6-months

Secondary outcomes (3)

  1. Weight Change in Kilogram

    Weight change in kilogram by group

    Measured: Baseline to 3 months

  2. Percent of Weight

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

    Measured: Baseline to 3 months

  3. Change in Body Mass Index (BMI)

    Change in body mass index per group

    Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJul 2016
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02278939
Sponsor's protocol ID
14-13100
Other IDs
1R34DK102100-01
Status last verified
Aug 2018
First submitted
28 Oct 2014
Last updated
28 Sep 2018
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • Chang L, Fukuoka Y, Aouizerat BE, Zhang L, Flowers E. Prediction of Weight Loss to Decrease the Risk for Type 2 Diabetes Using Multidimensional Data in Filipino Americans: Secondary Analysis. JMIR Diabetes. 2023 Apr 11;8:e44018. doi: 10.2196/44018.

    PubMed 37040172

  • 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.

    PubMed 30294699

Questions about this trial

What is this clinical trial studying?

A study testing Filipinos Fit and Trim Weight Loss Program in people with Pre-diabetes and Overweight, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count of Participants Who Completed the Study (time frame: Baseline to 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02278939, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.

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