ObesityNCT05168072
Weight Loss Effects of M-health App in Obesity Multidisciplinary Outpatient Clinic
A study testing m-Health app and conventional outpatient obesity management in people with Obesity and m-Health, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- m-Health app and conventional outpatient obesity management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- m-Health app, conventional outpatient obesity management
- Keywords
- obesity, NAFLD, m-Health
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-Health appDevice
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
conventional outpatient obesity managementOther
Diet and exercise guidance
| Study group | Role | What they receive |
|---|---|---|
| m-Health | Experimental | participants receive conventional outpatient obesity management assisted with m-Health APP Receives: Device: m-Health app; Other: conventional outpatient obesity management |
| conventional | Active comparator | participants receive conventional outpatient obesity management Receives: Other: conventional outpatient obesity management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in weight loss
changes in body weight from baseline were observed after 12 weeks of treatment intervention
Measured: 12 weeks
Changes in Nonalcoholic fatty liver disease
Changes in Nonalcoholic fatty liver disease (hepatic fibrosis index and liver fat attenuation parameters measured by Fibro touch) after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (3)
Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects
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
Measured: 12 weeks
Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol
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.
Measured: 12 weeks
Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase
The changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase would be measured at the beginning and the end.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start10 Dec 2021
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Dalong Zhu, MD,PhD, Principal investigator, the Affiliated Drum Tower Hospital of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168072
- Sponsor's protocol ID
- obesity2021
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient
- ClinicalTrials.gov ID
- NCT05168072
- Acronym / sponsor ID
- obesity2021
- Keywords
- obesity, NAFLD, m-Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| m-Health | Experimental | Device: m-Health app, Other: conventional outpatient obesity managementparticipants receive conventional outpatient obesity management assisted with m-Health APP |
| conventional | Active comparator | Other: conventional outpatient obesity managementparticipants receive conventional outpatient obesity management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| m-Health appM-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 | Device | m-Health |
| conventional outpatient obesity managementDiet and exercise guidance | Other | conventional, m-Health |
Primary outcome
Changes in weight loss
Time frame: 12 weeks
changes in body weight from baseline were observed after 12 weeks of treatment intervention
Changes in Nonalcoholic fatty liver disease
Time frame: 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
3 secondary outcomes
Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects
Time frame: 12 weeks
Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol
Time frame: 12 weeks
Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalong Zhu, MD,PhD principal investigator
the Affiliated Drum Tower Hospital of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing m-Health app and conventional outpatient obesity management in people with Obesity and m-Health, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in weight loss (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.