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Development and Evaluation of a Fogg Behavior Model–Based Digital Lifestyle Intervention for the Prevention of Gestational Diabetes Mellitus

Development and Evaluation of a Fogg Behavior Model–Based Digital Lifestyle Intervention for the Prevention of Gestational Diabetes Mellitus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112505
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-11-14
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Interventions

Digital Lifestyle Intervention Group:Pregnant women in the intervention group will receive a lifestyle digital intervention based on the Fogg Behavior Model, delivered via a WeChat mini-program to pro
Standard care group:Relevant health education manuals will be distributed during routine outpatient visits, daily health education will be provided, and health-related consultation services will be of

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Gestational age = 18 years; 3. Singleton intrauterine pregnancy with one or more of the following risk factors for gestational diabetes mellitus (GDM): (1) Maternal age >= 35 years; (2) Pre-pregnancy body mass index (BMI) >= 24 kg/m^2; (3) Polycystic ovary syndrome; (4) Family history of diabetes mellitus; (5) Previous history of GDM; (6) History of macrosomia delivery; (7) Multiparity; (8) Gestational hypertensive disorders; (9) Early pregnancy fasting plasma glucose between 5.1 mmol/L and < 7.0 mmol/L; 4. Ability to communicate effectively; 5. Ownership of and regular use of a smartphone; 6. Voluntarily participated in this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with type 1, type 2, or other specific types of diabetes mellitus; 2. Cervical insufficiency, defined as: (1) History of >= 3 painless late miscarriages or extremely preterm births without labor onset; or (2) History of <= 2 painless late miscarriages or extremely preterm births without labor onset, accompanied by transvaginal ultrasound measurement of cervical length <= 25 mm with progressive cervical dilation or shortening of the cervical canal; 3. History of psychiatric disorders; 4. Presence of cognitive impairment, visual impairment, hearing impairment, or physical disability; 5. Currently taking medication for pre-existing hypertension, heart disease, kidney disease, systemic lupus erythematosus, thyroid disorders, or other systemic diseases; 6. Currently undergoing treatment with metformin or corticosteroids; 7. Concurrent participation in other clinical research studies.

Design outcomes

Primary

MeasureTime frame
Incidence of gestational diabetes mellitus;

Secondary

MeasureTime frame
Glycemic control level;Rate of appropriate gestational weight gain;Dietary behavior (including dietary diversity and energy intake);Rate of adequate physical activity;Self-efficacy score;Self-management ability score of gestational diabetes mellitus;

Countries

China

Contacts

Public ContactZhao Yan

Peking University Third Hospital

zhaoyan@puh3.net.cn+86 138 1180 2162

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026