PilAm Go4Health Weight Loss Program to Prevent Heart Disease
Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease
研究概览
详细说明
Filipino Americans are the second largest Asian population and fastest growing racial group in the United States. They have one of the highest rates of insulin resistance (type 2 diabetes = T2DM) and central obesity (fat distributions primarily in the abdominal region). T2DM and central obesity are two of five major risk factors for metabolic syndrome that lead to cardiovascular disease and stroke. Key factors contributing to obesity and T2DM in Filipinos are their physical inactivity, and a diet high in fat and soda intake. However, there are very few research studies on improving health behaviors to reduce risks for metabolic syndrome in Filipino Americans. To help reduce the risk of developing metabolic syndrome in overweight/obese Filipino Americans with T2DM, the proposed project will test a culturally appropriate health behavior intervention program to reduce weight and waist circumference, through increasing physical activity, and lowering fat and sugar sweetened beverage intake. This intervention uses a mobile phone health app and social networking to encourage adherence to target health behaviors. The goals are to:
- To assess feasibility and acceptability of the culturally appropriate PilAm Go4Health Weight Loss Program
- To obtain preliminary estimates of the effect of the intervention on weight
- To conduct post-program process evaluations too improve the intervention relevancy for the target population.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Francisco、California、美国、94115
- San Francisco / Daly City Communities
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
4) 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention - PilAm Go4Health Program
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.
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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).
其他名称：
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有源比较器：Active control - pedometer only
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
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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
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Feasibility for Participant Enrollment and Retention
大体时间：Baseline to 6-months
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Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm
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Baseline to 6-months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Weight Change in Kilograms
大体时间：Baseline to 3 months
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weight change in kilograms over a 3 month period.
Intervention group will have a significantly greater reduction in weight change compared to the active control from baseline to 3-months
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Baseline to 3 months
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Percent Change in Weight (kg) From Baseline and 3 Months
大体时间：Baseline to 3 months
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100 x change in weight (kg) at 3 months divided by weight (kg) at baseline.
Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months.
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Baseline to 3 months
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Change in Waist Circumference
大体时间：baseline to 3 months
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Change in waist circumference over time within groups
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baseline to 3 months
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合作者和调查者
调查人员
- 首席研究员：Melinda S Bender, PhD、University of California, San Francisco
出版物和有用的链接
一般刊物
- 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. Erratum In: JMIR Diabetes. 2018 Dec 21;3(4):e12784.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 14-14158
- 14CRP19560008 (其他赠款/资助编号：American Heart Association)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 企业社会责任
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