Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,546
- 试验地点
- 1
- 主要终点
- Duration of exclusive breastfeeding
研究概览
简要总结
Gestational diabetes mellitus (GDM) is associated with an increased risk of childhood obesity and other adverse health outcomes. Early-life nutrition, particularly exclusive breastfeeding, plays an important role in reducing this risk. In Vietnam, infant feeding and childcare practices are strongly influenced by family members, including husbands, grandparents, and parents-in-law.
The Healthy Habits During and After Gestational Diabetes (VALID III) trial aims to evaluate the effect of a co-created family-based health intervention on improving infant feeding practices and childhood body composition among children born to women with GDM. The intervention includes counseling, peer support, digital health components, educational materials, and follow-up support for nutrition, infant feeding practices, physical activity, and GDM management from pregnancy through 24 months after birth. Participants in the control group will receive standard care together with access to a GDM management website.
The primary objective is to evaluate the effect of the intervention on the duration of exclusive breastfeeding during the first 180 days after birth. Secondary objectives include evaluating exclusive breastfeeding at 6 months, child fat mass index at 24 months, and broader maternal and child health and wellbeing outcomes.
详细描述
Background
Childhood obesity is a major global health burden, with increasing prevalence in many Asian countries, including Vietnam. However, health policies and programs in low- and middle-income countries (LMICs) often rely on evidence generated in settings that may not be directly applicable, limiting the effectiveness of interventions. Exposure to gestational diabetes mellitus (GDM) is associated with an increased risk of childhood obesity, while optimal early-life nutrition, particularly exclusive breastfeeding, may reduce this risk. In Vietnam, family members, including husbands, grandparents, and parents-in-law, have a substantial influence on infant feeding and childcare practices. These contextual factors highlight the need for family-based interventions to support healthy maternal and child behaviors following a pregnancy complicated by GDM.
Objectives
The Healthy Habits During and After Gestational Diabetes (VALID III) trial aims to evaluate the effect of the "Healthy Habits" family-based health intervention on improving infant feeding practices and childhood body composition among children born to women with GDM. The study will also assess the broader effects of the intervention on maternal and child health and wellbeing.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed GDM diagnosis in the current pregnancy according to WHO criteria and enrolled no longer than seven days after diagnosis.
- •Gestational age at enrolment ≤ 28+0 weeks of pregnancy.
- •Maternal age ≥18 years at consent.
- •Pregnancy with singleton gestation
- •Residence within the study catchment area.
- •Language proficiency sufficient to complete consent and study procedures in Vietnamese.
- •Capacity to provide informed consent and willingness to participate in all trial procedures, including randomisation
排除标准
- •Pregestational diabetes (type 1 or type 2) diagnosed prior to this pregnancy.
- •Severe chronic medical conditions and chronic severe mental health conditions likely to interfere with participation, safety, or outcome assessment (e.g., advanced cardiac, renal, hepatic disease; active malignancy; severe uncontrolled endocrine disease other than GDM, schizophrenia, active psychosis).
- •Inability to provide informed consent .
- •Pregnant women with multiple gestations.
- •Pregnant women where it is biologically impossible for the woman to breastfeed, e.g., the woman has undergone bilateral mastectomy.
- •Any other condition that, in the judgment of the investigators, makes participation inappropriate or infeasible, e.g., surrogate mother.
结局指标
主要结局
Duration of exclusive breastfeeding
时间窗: Day 1-180 after birth
Exclusive breastfeeding is defined as feeding with no other food or drink, except prescribed medicines, oral rehydration solution, vitamins, and minerals, following the first week of birth. Measured as a continuous variable representing the total number of days each infant was exclusively breastfed during the first 6 months of life. Data will be prospectively recorded by mothers on a weekly basis using a structured hard-copy Infant Feeding Diary kept at home. Research assistants will verify the diaries and capture content in photographs during home visits at 3 and 6 months after birth
次要结局
- Secondary outcome: Proportion of exclusive breastfeeding at 180 days (6 months) after birth(180 days (6 months) after birth)
- Child fat mass index (FMI) at 24 months after birth(24 months after birth)
研究者
Thanh Duc Nguyen
Head of International Relations Department
Thai Binh University of Medicine and Pharmacy