App and Body Fat Scale in the Management of Overweight Patients

May 31, 2025 updated by: Le Xiao, Capital Medical University

Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals With Mental Disorders Using Digital Intervention ("SWIM" Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will recruit the patients diagnosed with schizophrenia or bipolar disorder from Beijing Anding Hospital. Participants will use a mobile phone app (Huawei Health) to collect data on daily activities and calorie consumption. The smart body fat scale with high-precision weighing chip (Huawei Scale 2pro) will be used to collect heart rate, weight, BMI, body type, basal metabolic rate, fat rate, fat free body weight, skeletal muscle mass, bone salt content, visceral fat grade, body water (%), body protein rate and body composition, and all data will be uploaded to the app. Participants could also record their daily dietary intake (for calculation of calorie intake) in the health app. This is a 6-month, single-center, stepped wedge-shaped cluster randomized study. It is planned to recruit 204 overweight subjects from 6 units from Beijing Anding Hospital. The six clinical units comprise four inpatient wards, one day rehabilitation unit, and one outpatient department. All units (clusters) were randomly allocated to two batches (3 units each) using a computer-generated sequence. Batch 1 received the intervention from Month 3 to Month 6, while Batch 2 started from Month 5 to Month 6 (total study duration: 6 months). All units underwent baseline observation during Months 1-2, followed by a 2-week transition period for training. All clusters follow usual care prior to their assigned intervention period, with months 1-2 serving as baseline control and months 7-8 for full-intervention observation across all units. Each unit operates as an independent intervention cluster with dedicated staff teams and unit-specific WeChat-based communication groups. Intervention materials, reinforcement messages, counseling content, and technical support are synchronized with each cluster's assigned timeline. Clinical staff will be trained on intervention delivery, digital tool usage, and adherence protocols and are required to adhere strictly to the scheduled rollout sequence. Monitoring and supervision mechanisms will be implemented to track adherence, engagement, and protocol compliance in real-time. Each cluster undergoes a two-week pre-implementation transition period for device distribution, app installation, and training. The intervention combines self-weighing using using smart body fat scale, dietary logging, exercise management, and behavioral reinforcement. Behavioral reinforcement includes weekly personalized feedback messages and real-time alerts for missed self-monitoring via WeChat messages. We assess clinical, functional, and subjective outcomes at baseline and monthly intervals. Socio-demographic and clinical characteristics (age, sex, education, income, medical history) are extracted from EHRs. Body composition metrics (BMI, body fat percentage, etc.) are automatically recorded during weigh-ins. Subjective outcomes will be collected using validated scales at Month 1,2,3 and 6. Smart scale pairing success rate and weekly weigh-in adherence will be used to assess protocol feasibility. To capture user perspectives on mobile app and weighing smart scale, we will conduct 30-minute semi-structured interviews with 30 purposely selected participants (stratified by adherence and diagnosis), exploring app usability, behavioral impacts, and improvement suggestions.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Anding Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Batch 1 (Intervention from Month 3)
3 clinical units (clusters) receiving the combined digital and multidisciplinary intervention starting at Month 3. Each unit includes approximately 34 patients (total n=102) with schizophrenia or bipolar disorder.
Device: Effectiveness 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.
Experimental: Batch 2 (Intervention from Month 5)
3 clinical units (clusters) receiving the same intervention starting at Month 5. Each unit includes approximately 34 patients (total n=102) with schizophrenia or bipolar disorder.
Device: Effectiveness 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent weight loss
Time Frame: At the end of Months 1, 2, 3, and 6
Proportion of body weight lost, assessed via smart scale synced with app. Factors distinguish those who do/don't lose weight is detected by using machine learning.
At the end of Months 1, 2, 3, and 6
Adherence to self-monitoring
Time Frame: At the end of Months 1, 2, 3, and 6
Number of days per week participants complete self-weighing, dietary logging and follow up visits.
At the end of Months 1, 2, 3, and 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal adherence to self-monitoringcompliance to app + scale protocol and the participants who have bad compliance is compared by percent weight loss.
Time Frame: At the end of Months 1, 2, 3, and 6
Adherence measured as self-monitoring days per week, assessed monthly across the 6-month study.
At the end of Months 1, 2, 3, and 6
Weight loss by adherence level
Time Frame: At the end of Months 1, 2, 3, and 6
Comparison of percent weight loss between high- and low-adherence groups.
At the end of Months 1, 2, 3, and 6
Association between adherence and weight loss
Time Frame: At the end of Months 1, 2, 3, and 6
Independent variables include diagnosis, treatment, baseline weight, self-monitoring adherence, %WL from the previous month (e.g., %WL at the end of month 2 predicted self-monitoring during month 3), and the interaction between condition and %WL.
At the end of Months 1, 2, 3, and 6
Prediction of future adherence by prior weight loss
Time Frame: At the end of Months 1, 2, 3, and 6
Generalized linear mixed models will test whether weight loss in a given month predicts adherence in the following month.
At the end of Months 1, 2, 3, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Chair: Le Xiao, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

May 31, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISP#100150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data (including demographics, clinical outcomes, and body composition metrics) will be released to participants and referring clinicians upon request

IPD Sharing Time Frame

Data will be available from 6 months after primary publication for 5 years

IPD Sharing Access Criteria

Researchers must submit a proposal to the corresponding author, subject to approval by the ethics committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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