NCT05866107Recruiting
App and Body Fat Scale in the Management of Overweight Patients
Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals With Mental Disorders Using Digital Intervention ("SWIM" Trial)
Source: ClinicalTrials.gov · Last updated 5 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 6 Mar 2023
- Start date
- 31 Oct 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Capital Medical University
- Diseases
- Schizophrenia, Obesity, Bipolar disorder
- NCT number
- NCT05866107
What you commit to
- Study type: Interventional
- Planned participants: 204
- From 31 Oct 2023 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Plan to lose weight by other methods during the study period (such as dieting, inducing vomiting, taking diet pills, surgery).
Other illness
- Other secondary obesity (such as hypothyroidism, Cushing's syndrome, hypothalamic obesity, etc.).
- 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.
- 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.
Other
- Self-reported weight loss ≥ 7% in the past 6 months.
- Weight over 150 kg.
- Currently pregnant, lactating, \< 6 months postpartum or planning to become pregnant during the study period.
- Be unable to walk 30 minutes without stopping.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anding Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.