Antipsychotic-induced weight gain in first-episode psychosis patients: a meta-analysis of differential effects of antipsychotic medications.
Cenk Tek, Suat Kucukgoncu, Sinan Guloksuz...
https://pubmed.ncbi.nlm.nih.gov/25962699Actively Recruiting
Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID05866107
Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals With Mental Disorders Using Digital Intervention ("SWIM" Trial)
Led by Capital Medical University · Updated on 2025-06-05
204
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Capital Medical University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a digital health app called Huawei Health combined with a smart body fat scale to help overweight patients diagnosed with schizophrenia or bipolar disorder manage their weight. The study focuses on whether longer use of these tools leads to better weight loss and whether regular tracking motivates sustained engagement. The trial aims to improve long-term weight management through this digital and professional support approach. Participants will use the Huawei Health app and Huawei Scale 2pro smart body fat scale for self-monitoring. The intervention is rolled out in two batches: one group starts using the tools from Month 3 to Month 6, and the second group from Month 5 to Month 6. Patients weigh themselves weekly, log their diet at least three times per week, and follow biweekly exercise plans. They also receive weekly motivational messages and support from doctors and nutritionists via WeChat. During the 6-month study, participants undergo baseline observation, training, and intervention phases. Data collected include weight, BMI, body composition, heart rate, and dietary intake. Monthly assessments use validated scales to measure subjective outcomes. Adherence to self-monitoring and protocol compliance are tracked through the app and scale metrics. Researchers also conduct interviews to explore user experiences and assess the feasibility and effectiveness of this combined digital and multidisciplinary intervention.
CONDITIONS
Brief Title
App and Body Fat Scale in the Management of Overweight Patients
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18-60 years old, no gender restriction
- Diagnosed with bipolar disorder or schizophrenia per ICD-10 and currently in remission or stable
- Currently using at least one antipsychotic or mood stabilizer medication
- Overweight or obese with body mass index of 24 kg/m2 or higher and willing to use health app and smart scale
- Education level of primary school or above, able to understand scale content and proficient in smartphone use
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Planning to lose weight by other methods during the study (dieting, vomiting, diet pills, surgery)
- Self-reported weight loss of 7% or more in past 6 months
- Weight over 150 kg
- Secondary obesity due to other medical conditions (eg, hypothyroidism, Cushing's syndrome)
- Currently pregnant, lactating, less than 6 months postpartum, or planning pregnancy during study
- Self-reported cardiac discomfort or chest pain during activity or rest
- Serious medical condition posing safety risk for exercise
- Unable to walk 30 minutes without stopping
- Conditions affecting protocol compliance (eg, end-stage disease, substance abuse, uncontrolled medical issues)
- Any other conditions deemed inappropriate by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Observation
Duration - 2 months
Participants undergo baseline observation using usual care with no intervention to collect initial data on body composition and health status.
Monthly visits for assessments
Pre-implementation Transition
Duration - 2 weeks
Participants receive training on using the mobile app and smart body fat scale, including device distribution and installation.
1 to 2 visits for training and device setup
Intervention Period
Duration - Up to 4 months depending on cluster assignment
Participants use the digital behavioral intervention involving weekly weigh-ins with the smart scale, dietary logging at least three times per week, biweekly exercise plans, and weekly motivational messages.
Monthly visits for clinical, functional, and subjective outcome assessments; weekly remote monitoring through the app
Full-Intervention Observation
Duration - 2 months
All participants receive the digital intervention concurrently across all units, with continued self-monitoring and behavioral reinforcement.
Monthly visits for assessments and ongoing app-based monitoring
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
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Research Team
L
Le Xiao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Antipsychotic-associated weight gain: management strategies and impact on treatment adherence.
Madhubhashinee Dayabandara, Raveen Hanwella, Suhashini Ratnatunga...
https://pubmed.ncbi.nlm.nih.gov/28883731Frequency and Consistency of Self-Weighing to Promote Weight-Loss Maintenance.
Andrea N Brockmann, Abraham Eastman, Kathryn M Ross
https://pubmed.ncbi.nlm.nih.gov/32437055Self-Monitoring via Digital Health in Weight Loss Interventions: A Systematic Review Among Adults with Overweight or Obesity.
Michele L Patel, Lindsay N Wakayama, Gary G Bennett
https://pubmed.ncbi.nlm.nih.gov/33624440The efficacy of wearable activity tracking technology as part of a weight loss program: a systematic review.
Scott W Cheatham, Kyle R Stull, Mike Fantigrassi...
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Lorna Suen, Wenru Wang, Kenneth King Yip Cheng...
https://pubmed.ncbi.nlm.nih.gov/31144666Mobile Phone Apps to Promote Weight Loss and Increase Physical Activity: A Systematic Review and Meta-Analysis.
Gemma Flores Mateo, Esther Granado-Font, Carme Ferré-Grau...
https://pubmed.ncbi.nlm.nih.gov/26554314Associations between self-monitoring and weight change in behavioral weight loss interventions.
Stephanie P Goldstein, Carly M Goldstein, Dale S Bond...
https://pubmed.ncbi.nlm.nih.gov/31556659Comparing Self-Monitoring Strategies for Weight Loss in a Smartphone App: Randomized Controlled Trial.
Michele L Patel, Christina M Hopkins, Taylor L Brooks...
https://pubmed.ncbi.nlm.nih.gov/30816851