App plus smart body fat scale program to help overweight people with schizophrenia or bipolar disorder lose weight
Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals With Mental Disorders Using Digital Intervention ("SWIM" Trial)
See if using the Huawei Health app together with a smart body fat scale helps overweight people with schizophrenia or bipolar disorder lose weight and stay involved in their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05866107 on ClinicalTrials.gov |
What this trial studies
This is a single-center, stepped-wedge cluster randomized study at Beijing Anding Hospital enrolling about 204 overweight adults with schizophrenia or bipolar disorder. Participants use a Huawei Health mobile app and a Huawei Scale 2 Pro that auto-syncs weight and body composition while they log diet and activity; the app gives personalized diet and exercise tips and clinicians provide extra messaging support. Clusters (six clinical units) switch from usual care to the digital intervention at different times so some participants receive longer exposure than others, allowing comparison of different durations of use. The main outcomes compare weight change and engagement over a total 6-month study period.
Who should consider this trial
Good fit: Adults 18–60 with a diagnosis of schizophrenia or bipolar disorder who are clinically stable/remitted, currently taking antipsychotic or mood‑stabilizing medication, have BMI ≥24 kg/m2, can use a smartphone, and consent to use the app and scale.
Not a fit: Patients who are acutely psychotic or unable to use a smartphone, plan other weight-loss methods, have recent large weight loss, or weigh over 150 kg may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the combined app and smart scale program could help patients with serious mental illness lose weight and maintain healthier habits with remote clinician support.
How similar studies have performed: Digital self-monitoring and smart-scale programs have shown modest weight loss in general populations and mixed but promising results in some studies of people with serious mental illness, but definitive evidence in this specific group is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Anding Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Le Xiao
- Email: xiaole373@163.com
- Phone: +8613466604224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.