SchizophreniaNCT05866107
App and Body Fat Scale in the Management of Overweight Patients
A study testing Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals with Mental Disorders Using Digital Intervention ("SWIM" trial) in people with Schizophrenia and Bipolar Disorder, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Metabolic Syndrome
- What is being tested?
- Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals with Mental Disorders Using Digital Intervention ("SWIM" trial)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anding Hospital
Beijing, Beijing Municipality
Le Xiao, 8613466604224, xiaole373@163.com
About this study
Official title: 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:
Read more
- 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).
- Patients who track their weight, diet, and exercise regularly (≥3 times/week) will lose more weight than those who don't.
- 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.
Read the 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.
- Being tested
- Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals with Mental Disorders Using Digital Intervention ("SWIM" trial)
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Metabolic Syndrome, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Weekly weigh-ins (auto-synced)
- Dietary logging (≥3x/week) with calorie-deficit targets
- Biweekly exercise plans (150-300 min/week)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals with Mental Disorders Using Digital Intervention ("SWIM" trial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Adherence measured as self-monitoring days per week, assessed monthly across the 6-month study.
Measured: At the end of Months 1, 2, 3, and 6
Weight loss by adherence level
Comparison of percent weight loss between high- and low-adherence groups.
Measured: At the end of Months 1, 2, 3, and 6
Association between adherence and weight loss
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.
Measured: At the end of Months 1, 2, 3, and 6
Prediction of future adherence by prior weight loss
Generalized linear mixed models will test whether weight loss in a given month predicts adherence in the following month.
Measured: At the end of Months 1, 2, 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start31 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Le Xiao, Capital Medical University
- Investigators
- Le Xiao, Study chair, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866107
- Sponsor's protocol ID
- MISP#100150
- Status last verified
- May 2025
- First submitted
- 6 Mar 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data (including demographics, clinical outcomes, and body composition metrics) will be released to participants and referring clinicians upon request
Publications
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.
PubMed 25962699Dayabandara 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.
PubMed 28883731Brockmann 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.
PubMed 32437055Patel 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.
PubMed 33624440Cheatham 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.
PubMed 28488834Suen 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.
PubMed 31144666Flores 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.
PubMed 26554314Goldstein 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.
PubMed 31556659Patel 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.
PubMed 30816851Wu J, Xu J, Bi J, Zhu X, Xiao L. Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals With Mental Disorders Using Digital Intervention: Protocol for a Stepped-Wedge Cluster Randomized Trial ("SWIM" Study). JMIR Res Protoc. 2026 Apr 27;15:e78420. doi: 10.2196/78420.
PubMed 42044368
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals With Mental Disorders Using Digital Intervention ("SWIM" Trial)
- ClinicalTrials.gov ID
- NCT05866107
- Acronym / sponsor ID
- MISP#100150
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Patients who track their weight, diet, and exercise regularly (≥3 times/week) will lose more weight than those who don't.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Batch 1 (Intervention from Month 3) | Experimental | Device: Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals with Mental Disorders Using Digital Intervention ("SWIM" trial)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. |
| Batch 2 (Intervention from Month 5) | Experimental | Device: Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals with Mental Disorders Using Digital Intervention ("SWIM" trial)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Batch 1 (Intervention from Month 3), Batch 2 (Intervention from Month 5) |
Primary outcome
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.
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.
4 secondary outcomes
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
Weight loss by adherence level
Time frame: 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
Prediction of future adherence by prior weight loss
Time frame: At the end of Months 1, 2, 3, and 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Results publication: PubMed 25962699Tek 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.
- Results publication: PubMed 28883731Dayabandara 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.
- Results publication: PubMed 32437055Brockmann 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.
- Results publication: PubMed 33624440Patel 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.
- Results publication: PubMed 28488834Cheatham 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.
- Results publication: PubMed 31144666Suen 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.
- Results publication: PubMed 26554314Flores 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.
- Results publication: PubMed 31556659Goldstein 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.
- Results publication: PubMed 30816851Patel 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.
- Derived from this study: PubMed 42044368Wu J, Xu J, Bi J, Zhu X, Xiao L. Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals With Mental Disorders Using Digital Intervention: Protocol for a Stepped-Wedge Cluster Randomized Trial ("SWIM" Study). JMIR Res Protoc. 2026 Apr 27;15:e78420. doi: 10.2196/78420.
- Individual participant dataSharing planned: Yes. De-identified participant data (including demographics, clinical outcomes, and body composition metrics) will be released to participants and referring clinicians upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Le Xiao study chair
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals with Mental Disorders Using Digital Intervention ("SWIM" trial) in people with Schizophrenia and Bipolar Disorder, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Le Xiao (+8613466604224, xiaole373@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight loss (time frame: At the end of Months 1, 2, 3, and 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866107, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.