RecruitingNot ApplicableNCT05866107

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)


Sponsor

Capital Medical University

Enrollment

204 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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 Criteria11

  • 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.

Interventions

DEVICEEffectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals with Mental Disorders Using Digital Intervention ("SWIM" trial)

Participants receive a digital-behavioral intervention via Huawei Health App and smart scale: 1. Weekly weigh-ins (auto-synced) 2. Dietary logging (≥3x/week) with calorie-deficit targets 3. Biweekly exercise plans (150-300 min/week) 4. Weekly motivational messages Implementation: Staggered rollout: Batch 1 (Month 3-6), Batch 2 (Month 5-6). Includes 2-week training. Effectiveness monitored via app metrics and adherence. Routine care maintained.


Locations(1)

Beijing Anding Hospital

Beijing, Beijing Municipality, China

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NCT05866107


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