NCT05866107 App and Body Fat Scale in the Management of Overweight Patients
| NCT ID | NCT05866107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Capital Medical University |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2023-10-31 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study tests whether using a health app (Huawei Health) and a smart body fat scale can help overweight patients with schizophrenia or bipolar disorder lose weight and stay engaged in their health. What We're Testing: 1. Patients who use the app and scale for 4 months (Group 1) will lose more weight than those who use them for 2 months (Group 2). 2. Patients who track their weight, diet, and exercise regularly (≥3 times/week) will lose more weight than those who don't. 3. Seeing weight loss results may motivate patients to keep using the app and scale. How It Works: Patients weigh themselves weekly with the scale (auto-syncs to the app) and upload dietary log in Huawei Health app. The app will gives personalized diet/exercise tips and tracks progress. Doctors and nutritionists provide extra support through messages. Goal: To see if this digital tool + professional support combo works better for long-term weight management.
Eligibility Criteria
Inclusion Criteria: * Age 18-60 years old, no gender restriction. * According to ICD-10 to diagnose bipolar disorder or schizophrenia, the researcher judges that the patient is currently in remission, or the condition is stable and can cooperate with the research. * Currently using at least one antipsychotic or mood stabilizer (e.g. lithium, magnesium valproate, sodium valproate, lamotrigine). * Currently overweight or obese (body mass index ≥ 24kg/m2) and willing to use health app and smart scales to lose weight. * The education level of primary school or above, able to understand the content of the scale, and be able to use smart phone proficiently. * Understand and voluntarily participate in this study, and sign the informed consent form. Exclusion Criteria: * Plan to lose weight by other methods during the study period (such as dieting, inducing vomiting, taking diet pills, surgery). * Self-reported weight loss ≥ 7% in the past 6 months. * Weight over 150 kg. * Other secondary obesity (such as hypothyroidism, Cushing's syndrome, hypothalamic obesity, etc.). * Currently pregnant, lactating, \< 6 months postpartum or planning to become pregnant during the study period. * Self-reported cardiac discomfort or chest pain during activity or at rest. * There is a serious medical condition, and the researchers believe that there may be safety risks when participating in sports. * Be unable to walk 30 minutes without stopping. * There are problems that may affect compliance with the protocol (eg, end-stage disease, planning to move travel to the field, history of substance abuse, other uncontrolled or untreated medical conditions); * Any other conditions deemed inappropriate by the investigator. Participants include approximately 50% with schizophrenia and 50% with bipolar disorder, distributed across all clusters.
Contact & Investigator
Le Xiao
STUDY CHAIR
Capital Medical University
Frequently Asked Questions
Who can join the NCT05866107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05866107 currently recruiting?
Yes, NCT05866107 is actively recruiting participants. Contact the research team at xiaole373@163.com for enrollment information.
Where is the NCT05866107 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05866107 clinical trial?
NCT05866107 is sponsored by Capital Medical University. The principal investigator is Le Xiao at Capital Medical University. The trial plans to enroll 204 participants.
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