Weight Loss Effects of M-health App in Obesity Multidisciplinary Outpatient Clinic
Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient
調査の概要
詳細な説明
This is a randomized, open, controlled, single-center trial to identify the weight loss effects of adding mobile health application in obesity multidisciplinary outpatient clinic.
The team of obesity multidisciplinary outpatient clinic includes endocrinologists, dietitians, and exercisers. The endocrinologist assesses the patients' conditions, manages the patients, and decides on appropriate medications. Dietitians participate in dietary propaganda and education, and develop personalized diet prescriptions. Exercisers conduct behavior and exercise propaganda, and issue personalized exercise prescriptions. Patients in the experimental group combine m-Health APP with routine obesity clinic management. The m-Health APP could help patients set weight loss targets, record body weights online, learn the calories they consumed in real time, and exercise based on the prescriptions suggested by the exercisers.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、210008
- Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
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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:
- between 18 and 65 years old;
- 24kg/m^2 ≤ BMI < 37.5kg/m^2;
- Proficient in using mobile applications;
- Agree to sign the informed consent
Exclusion Criteria:
- secondary obesity (such as hypothyroidism, Cushing's syndrome, hypothalamic obesity or long-term use of obesity-causing drugs, etc.);
- Patients with chronic diseases that require special diet and affect exercise;
- Patients suffering from severe liver, kidney or heart dysfunction;
- Patients with a history of malignant tumor;
- Pregnant or lactating women;
- Low level of education or illiteracy;
- Inability, unwillingness, or refusal to comply with study requirements (including lifestyle adjustments, follow-up, and subject duties)
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
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：m-Health
participants receive conventional outpatient obesity management assisted with m-Health APP
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M-Health app is used to set weight loss targets and record body weights online.
Participants learn the calories they consumed by using the m-Health APP and follow the APP for physical exercise
Diet and exercise guidance
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アクティブコンパレータ：conventional
participants receive conventional outpatient obesity management
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Diet and exercise guidance
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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 |
|---|---|---|
|
Changes in weight loss
時間枠：12 weeks
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changes in body weight from baseline were observed after 12 weeks of treatment intervention
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12 weeks
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Changes in Nonalcoholic fatty liver disease
時間枠：12 weeks
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Changes in Nonalcoholic fatty liver disease (hepatic fibrosis index and liver fat attenuation parameters measured by Fibro touch) after 12 weeks of treatment
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12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects
時間枠：12 weeks
|
All 40 subjects of each group would be evaluated by changes in body mass index ( BMI(kg/m^2)=body weight(kg)/height(m^2)) after 12 weeks treatment
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12 weeks
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Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol
時間枠：12 weeks
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The changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol would be measured at the beginning and the end.
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12 weeks
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Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase
時間枠：12 weeks
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The changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase would be measured at the beginning and the end.
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12 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
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。