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NCT05866107 | NOT YET RECRUITING | Schizophrenia

App and Body Fat Scale in the Management of Overweight Patients
Sponsor:

Capital Medical University

Information provided by (Responsible Party):

Lexi

Brief Summary:

Primary objective: To examine the impact of the sustained use of the health app and smart body fat scale on weight management and patient engagement Secondary objectives: 1. To compare the difference in weight loss between the participants who have good compliance to app + scale protocol and the participants who have bad compliance 2. To evaluate the longitudinal association between self-monitoring adherence and percent weight loss. 3. To evaluate the prospective association between monthly % weight loss and the subsequent month of self-monitoring adherence List the clinical hypotheses: 1. At least 50% of participants will achieve 7% weight reduction compared with baseline by self-weight monitoring using smart body fat scale and health app. 2. The self-monitoring adherence is associated with greater weight loss. 3. The monthly weight loss is associated with the subsequent month of self-monitoring adherence. 4. The self-weight monitoring using smart body fat scale and health app are feasible by evaluating the compliance and completeness of the data.

Condition or disease

Schizophrenia

Bipolar Disorder

Metabolic Syndrome

Intervention/treatment

self-monitoring of weight using smart body fat scale with high-precision weighing chip (Huawei Scale 2pro), a mobile phone app (Huawei Health), dietary management, and exercise management.

Phase

NA

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 sleep log, 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 200 overweight subjects, including 100 patients with schizophrenia and 100 patients with bipolar disorder, who are receiving antipsychotics,. Interventions included self-monitoring of weight using smart body fat scale, dietary management, and exercise management. The follow-up team consists of a psychiatrist, nutrition instructor, and exercise instructor who set weight loss goals and implemented a plan. The patients themselves use the health APP and smart body fat scale to record health data such as body weight; psychiatrists evaluate the patient's condition and conduct laboratory tests; nutrition instructors conduct dietary education and formulate individualized energy-limited balanced diet prescriptions; exercise instructors conduct behavioral ways and sports education, and individualized exercise prescriptions.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Effectiveness and Feasibility of Health App and Smart Body Fat Scale in the Management of Health Outcomes in the Overweight Patients Treated With Antipsychotics: a Stepped-wedge Cluster Randomized Study
Actual Study Start Date : 2023-10-15
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2024-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
App and Body Fat Scale in the Management of Overweight Patients

Location Details

NCT05866107

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