- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05168072
Weight Loss Effects of M-health App in Obesity Multidisciplinary Outpatient Clinic
Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국, 210008
- Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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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활성 비교기: conventional
participants receive conventional outpatient obesity management
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Diet and exercise guidance
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in weight loss
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects
기간: 12 weeks
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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
기간: 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
기간: 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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .