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Effects of dietary intervention based on behaviour change wheel on glucose metabolism and pregnancy outcomes in pregnant women with gestational diabetes mellitus

Effects of dietary intervention based on behaviour change wheel on glucose metabolism and pregnancy outcomes in pregnant women with gestational diabetes mellitus: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059021
Enrollment
Unknown
Registered
2022-04-23
Start date
2022-05-09
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

Gestational diabetes mellitus

Interventions

Intervention Group:Dietary intervention group based on BCW

Sponsors

Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women diagnosed with GDM by a clinical 75g oral glucose tolerance test (OGTT) within 24-28 weeks of gestation are eligible to participate. The glucose concentration thresholds of pregnant women accord with IADPSG criteria in 2010: fasting blood glucose (FBG) >=5.1 mmol/L and/or 1-h plasma glucose after taking sugar >=10.0 mmol/L and/or 2-h plasma glucose after taking sugar >=8.5 mmol/L; 2. Aged between 18 and 40 years; 3. Naturally pregnancy; 4. Singleton pregnancy verified by ultrasound; 5. Have adequate cognitive and behavioral abilities; 6. No previous endocrine-related diseases, such as hyperthyroidism, hypothyroidism, and Cushing's syndrome; 7. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have pre-pregnancy diabetes mellitus(type1 or type2 diabetes), or who have been treated with insulin or other diabetic drugs; 2. Ultrasound results showed that the fetus had serious congenital abnormalities; 3. Pre-existing pregnancy comorbidities, such as mental illness, heart failure, renal failure, and severe liver disease; 4. Existing pregnancy complications, such as severe anemia, threated abortion and fetal intrauterine growth restriction; 5. Using drugs that may affect OGTT results, such as steroids or immunosuppressants; 6. Those have the history of smoking, alcohol or drug abuse; 7. Those who have special dietary requirements, such as vegans or those who have special food allergies.

Design outcomes

Primary

MeasureTime frame
Adverse pregnancy outcomes;Fasting blood glucose value and 2h postprandial blood glucose value;Glycosylated hemoglobin value (HbA1c);

Secondary

MeasureTime frame
Self-management behaviour;Self-efficacy;

Countries

China

Contacts

Public ContactChen Xiaoli

Wuhan University School of Nursing

chenxl72@whu.edu.cn+86 18995600467

Outcome results

None listed

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