App plus smart body fat scale program to help overweight people with schizophrenia or bipolar disorder lose weight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Anding Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Le Xiao
• Email: xiaole373@163.com
• Phone: +8613466604224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.