PilAm Go4Health Weight Loss Program to Prevent Heart Disease

NCT02290184 | Completed Results

• 2 other identifiers: 14-1415814CRP19560008
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type2 Diabetes

Keywords

Type 2 diabetes; cardiovascular disease prevention; weight loss lifestyle intervention; physical activity; diet; Filipinos

Outcome Measures

Primary Outcomes (1)

• Feasibility for Participant Enrollment and Retention

  Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm

  Baseline to 6-months

Secondary Outcomes (3)

• Weight Change in Kilograms

  Baseline to 3 months

• Percent Change in Weight (kg) From Baseline and 3 Months

  Baseline to 3 months

• Change in Waist Circumference

  baseline to 3 months

Study Arms (2)

Intervention - PilAm Go4Health Program

EXPERIMENTAL

In the first 3 months this groups will start with the PilAm Go4Health Weight-loss Program lifestyle intervention. After 3 months this group will transition to a 3-month maintenance phase where they will continue to maintain the physical activity and healthy eating behaviors learned in the PilAm Go4Health Weight-loss Program lifestyle intervention and will complete the study for a total of 6 months.

Behavioral: PilAm Go4Health Weight-loss Program

Active control - pedometer only

ACTIVE COMPARATOR

In the first 3 months this groups will start with a pedometer only. After 3 months, this group will transition to receive the PilAm Go4Health Weight-loss Program lifestyle intervention for the next 3 month and will complete the study for a total of 6 months

Behavioral: Active Control

Interventions

PilAm Go4Health Weight-loss Program BEHAVIORAL

This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts).

Also known as: PilAm Go4Health Program

Intervention - PilAm Go4Health Program

Active Control BEHAVIORAL

This is a 3-month active control using a pedometer only without any education related to wt loss, physical activity, health eating, or tracking healthy behaviors

Also known as: pedometer only

Active control - pedometer only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco / Daly City Communities

San Francisco, California, 94115, United States

Location

Related Publications (2)

• Bender MS, Cooper BA, Park LG, Padash S, Arai S. A Feasible and Efficacious Mobile-Phone Based Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Randomized Controlled Trial. JMIR Diabetes. 2017 Dec 12;2(2):e30. doi: 10.2196/diabetes.8156.

  PMID: 30291068 DERIVED

• Bender MS, Santos GM, Villanueva C, Arai S. Development of a Mobile Phone-Based Weight Loss Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Protocol and Early Results From the PilAm Go4Health Randomized Controlled Trial. JMIR Res Protoc. 2016 Sep 8;5(3):e178. doi: 10.2196/resprot.5836.

  PMID: 27608829 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Limitations and Caveats

Due to the study's small sample size and sample recruitment to one geographical region, study results cannot be generalized to other populations.

Results Point of Contact

• Title: Melinda Sarmiento Bender, PhD, RN
• Organization: University of California San Francisco

melinda.bender@ucsf.edu

415 502 5668

Study Officials

• Melinda S Bender, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistician has been masked from any subjects' personal and confidential information
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2014
• First Posted: November 13, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2017
• Last Updated: April 8, 2019
• Results First Posted: January 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.
• 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 University of California San Francisco (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 computer disk (CD) or through a password-protected download from our website.

Locations

US (1)