App and Body Fat Scale in the Management of Overweight Patients

NCT05866107 | Recruiting

• 1 other identifier: MISP#100150
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Patients who track their weight, diet, and exercise regularly (≥3 times/week) will lose more weight than those who don't.
3. 3.Seeing weight loss results may motivate patients to keep using the app and scale.

Conditions

Schizophrenia; Bipolar Disorder; Metabolic Syndrome; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Percent weight loss

  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

  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 Outcomes (4)

• Longitudinal adherence to self-monitoringcompliance to app + scale protocol and the participants who have bad compliance is compared by percent weight loss.

  At the end of Months 1, 2, 3, and 6

• Weight loss by adherence level

  At the end of Months 1, 2, 3, and 6

• Association between adherence and weight loss

  At the end of Months 1, 2, 3, and 6

• Prediction of future adherence by prior weight loss

  At the end of Months 1, 2, 3, and 6

Study Arms (2)

Batch 1 (Intervention from Month 3)

EXPERIMENTAL

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)

Batch 2 (Intervention from Month 5)

EXPERIMENTAL

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)

Interventions

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

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.

Batch 1 (Intervention from Month 3); Batch 2 (Intervention from Month 5)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Beijing Anding Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (9)

• Tek C, Kucukgoncu S, Guloksuz S, Woods SW, Srihari VH, Annamalai A. Antipsychotic-induced weight gain in first-episode psychosis patients: a meta-analysis of differential effects of antipsychotic medications. Early Interv Psychiatry. 2016 Jun;10(3):193-202. doi: 10.1111/eip.12251. Epub 2015 May 12.

  PMID: 25962699 RESULT

• Dayabandara M, Hanwella R, Ratnatunga S, Seneviratne S, Suraweera C, de Silva VA. Antipsychotic-associated weight gain: management strategies and impact on treatment adherence. Neuropsychiatr Dis Treat. 2017 Aug 22;13:2231-2241. doi: 10.2147/NDT.S113099. eCollection 2017.

  PMID: 28883731 RESULT

• Brockmann AN, Eastman A, Ross KM. Frequency and Consistency of Self-Weighing to Promote Weight-Loss Maintenance. Obesity (Silver Spring). 2020 Jul;28(7):1215-1218. doi: 10.1002/oby.22828. Epub 2020 May 21.

  PMID: 32437055 RESULT

• Patel ML, Wakayama LN, Bennett GG. Self-Monitoring via Digital Health in Weight Loss Interventions: A Systematic Review Among Adults with Overweight or Obesity. Obesity (Silver Spring). 2021 Mar;29(3):478-499. doi: 10.1002/oby.23088.

  PMID: 33624440 RESULT

• Cheatham SW, Stull KR, Fantigrassi M, Motel I. The efficacy of wearable activity tracking technology as part of a weight loss program: a systematic review. J Sports Med Phys Fitness. 2018 Apr;58(4):534-548. doi: 10.23736/S0022-4707.17.07437-0. Epub 2017 May 9.

  PMID: 28488834 RESULT

• Suen L, Wang W, Cheng KKY, Chua MCH, Yeung JWF, Koh WK, Yeung SKW, Ho JYS. Self-Administered Auricular Acupressure Integrated With a Smartphone App for Weight Reduction: Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2019 May 29;7(5):e14386. doi: 10.2196/14386.

  PMID: 31144666 RESULT

• Flores Mateo G, Granado-Font E, Ferre-Grau C, Montana-Carreras X. Mobile Phone Apps to Promote Weight Loss and Increase Physical Activity: A Systematic Review and Meta-Analysis. J Med Internet Res. 2015 Nov 10;17(11):e253. doi: 10.2196/jmir.4836.

  PMID: 26554314 RESULT

• Goldstein SP, Goldstein CM, Bond DS, Raynor HA, Wing RR, Thomas JG. Associations between self-monitoring and weight change in behavioral weight loss interventions. Health Psychol. 2019 Dec;38(12):1128-1136. doi: 10.1037/hea0000800. Epub 2019 Sep 26.

  PMID: 31556659 RESULT

• Patel ML, Hopkins CM, Brooks TL, Bennett GG. Comparing Self-Monitoring Strategies for Weight Loss in a Smartphone App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 28;7(2):e12209. doi: 10.2196/12209.

  PMID: 30816851 RESULT

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Metabolic Syndrome; Overweight; Obesity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Le Xiao

  Capital Medical University

  STUDY CHAIR

Central Study Contacts

Le Xiao

CONTACT

+8613466604224; xiaole373@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Beijing Anding Hospital

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 19, 2023
• Study Start: October 31, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available from 6 months after primary publication for 5 years
• Access Criteria: Researchers must submit a proposal to the corresponding author, subject to approval by the ethics committee

Locations

CN (1)