PilAm Go4Health Weight Loss Program to Prevent Heart Disease
Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94115
- San Francisco / Daly City Communities
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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).
他の名前：
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アクティブコンパレータ：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility for Participant Enrollment and Retention
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Weight Change in Kilograms
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Melinda S Bender, PhD、University of California, San Francisco
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 14-14158
- 14CRP19560008 (その他の助成金/資金番号：American Heart Association)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
- CSR
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。