Weight Loss Effects of M-health App in Obesity Multidisciplinary Outpatient Clinic
22. december 2021 opdateret af: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient
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.
Studieoversigt
Status
Tilmelding efter invitation
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Jiangsu
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Nanjing, Jiangsu, Kina, 210008
- Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: m-Health
participants receive conventional outpatient obesity management assisted with m-Health APP
|
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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Aktiv komparator: conventional
participants receive conventional outpatient obesity management
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Diet and exercise guidance
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in weight loss
Tidsramme: 12 weeks
|
changes in body weight from baseline were observed after 12 weeks of treatment intervention
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12 weeks
|
|
Changes in Nonalcoholic fatty liver disease
Tidsramme: 12 weeks
|
Changes in Nonalcoholic fatty liver disease (hepatic fibrosis index and liver fat attenuation parameters measured by Fibro touch) after 12 weeks of treatment
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects
Tidsramme: 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
Tidsramme: 12 weeks
|
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
Tidsramme: 12 weeks
|
The changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase would be measured at the beginning and the end.
|
12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. december 2021
Primær færdiggørelse (Forventet)
20. december 2022
Studieafslutning (Forventet)
20. december 2023
Datoer for studieregistrering
Først indsendt
1. december 2021
Først indsendt, der opfyldte QC-kriterier
22. december 2021
Først opslået (Faktiske)
23. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- obesity2021
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