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Healthy Habits During and After Gestational Diabetes (VALID III)

20 de julho de 2026 atualizado por: Thanh Duc Nguyen, Thai Binh University of Medicine and Pharmacy

Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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

This is a two-arm, parallel-group, superiority cluster randomised controlled trial with a 1:1 allocation of communes to either the intervention group (standard care plus the "Healthy Habits" intervention) or the control group (standard care plus access to a GDM management website). Pregnant women diagnosed with GDM between 24 and 28 weeks of gestation and their families will be recruited. Participants will be followed from pregnancy until 24 months after birth.

Intervention

The "Healthy Habits" intervention is a co-created family-based program delivered during pregnancy and continuing until 24 months postpartum. It includes counseling, peer support, digital health components, educational materials, and follow-up support focused on nutrition, infant feeding practices, physical activity, and GDM management, alongside routine clinical care.

Outcome Assessment

The primary outcome is the duration of exclusive breastfeeding during the first 180 days after birth. Secondary outcomes include the proportion of infants exclusively breastfed at 6 months, child fat mass index at 24 months after birth, process outcomes, and broader maternal and child health and wellbeing outcomes.

Tipo de estudo

Intervencional

Inscrição (Estimado)

2546

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Thanh Duc Nguyen, Assoc. Prof
  • Número de telefone: +84 91 235 7575
  • E-mail: bsthanh@hotmail.com

Locais de estudo

  • Vietnã
    • Hưng Yên Province
      • Thái Bình, Hưng Yên Province, Vietnã
        • Thai Binh University of Medicine and Pharmacy
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Healthy Habits
A co-created intervention delivered during pregnancy and up to two years after birth that includes counselling, peer support, digital health elements, educational materials, and follow-up support on nutrition, infant feeding practices, physical activity, and GDM management provided according to routine clinical practice in the Hung Yen province, Vietnam
Comportamental: Hybrid intervention

The VALID III "Healthy Habits" intervention is a culturally tailored, gender-sensitive, intergenerational complex intervention for women with gestational diabetes mellitus (GDM), delivered from diagnosis to 24 months postpartum. It differs from standard care through its extended duration and integrated family- and digital-based approach.

It includes five components: (1) nutrition and infant feeding support (diet, breastfeeding, complementary feeding, household practices); (2) physical activity guidance for pregnancy/postpartum and family active play; (3) intergenerational family engagement involving partners and grandparents; (4) self-care and GDM management including diet advice, blood glucose monitoring, and free clinic testing; and (5) digital support via messaging and educational content.

Compared with usual care, the intervention integrates co-created materials, family involvement, and continuous digital engagement to support sustained behavioural change
Comparador Ativo: Standard Care + Web Access
Access to a website with GDM management + standard care
Comportamental: Standard Care with Passive Web Access
Participants in this control group receive standard care for GDM according to routine clinical practice in Vietnam (antenatal care, dietary advice, glucose monitoring). In addition, they are provided with a website link (https://www.babaukhoemanh.com/en) for passive access to basic GDM management guidance. They do not receive any proactive messaging, peer support, or family engagement

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Duration of exclusive breastfeeding
Prazo: 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
Day 1-180 after birth

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Secondary outcome: Proportion of exclusive breastfeeding at 180 days (6 months) after birth
Prazo: 180 days (6 months) after birth
Proportion of exclusive breastfeeding (as defined above) at 180 days after birth.
180 days (6 months) after birth
Child fat mass index (FMI) at 24 months after birth
Prazo: 24 months after birth
Fat Mass Index (FMI)= Fat mass (kg)/height (m2)
24 months after birth

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Maternal long-term metabolic health
Prazo: 24 months after birth.
Maternal metabolic health biomarkers comprise measures of glycaemic control (HbA1c, fasting glucose), insulin metabolism (fasting insulin and C-peptide), and lipid metabolism (LDL cholesterol, HDL cholesterol, triglycerides, and total cholesterol).
24 months after birth.
Maternal Informal social support
Prazo: Baseline (24-28 weeks' gestation, at the time of the oral glucose tolerance test [OGTT]), 6, 12, and 24 months after birth
Maternal perceived availability and adequacy of informal social support from family, friends, and significant others, reflecting the mother's access to emotional, informational, and practical support.
Baseline (24-28 weeks' gestation, at the time of the oral glucose tolerance test [OGTT]), 6, 12, and 24 months after birth
Maternal quality of life
Prazo: Baseline (at the time of the oral glucose tolerance test, performed between 24 and 28 weeks of gestation), 6, 12, and 24 months after birth
Maternal quality of life, including health-related quality of life, family health, and maternal mental health, reflecting physical, psychological, and social well-being after childbirth
Baseline (at the time of the oral glucose tolerance test, performed between 24 and 28 weeks of gestation), 6, 12, and 24 months after birth
Child socio-emotional development
Prazo: At 6, 12 and 24 months after birth
Child feeding patterns, behaviours, illness patterns, and environmental factors related to obesity risk, including dietary intake and diet quality, sedentary behaviour and screen time, physical activity, sleep duration, parenting practices (feeding, activity, sleep), and household food environment
At 6, 12 and 24 months after birth
Child fat mass
Prazo: At 6, 12, and 24 months after birth
Child fat mass and fat-free mass
At 6, 12, and 24 months after birth
Maternal glycaemic control in pregnancy
Prazo: Baseline (at diagnosis of gestational diabetes mellitus during 24-28 weeks of gestation) and at delivery
HbA1c (glycated haemoglobin) reflects the average blood glucose concentration over the past ~8-12 weeks and is measured from a blood sample
Baseline (at diagnosis of gestational diabetes mellitus during 24-28 weeks of gestation) and at delivery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Thai Binh University of Medicine and Pharmacy

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de novembro de 2026

Conclusão Primária (Estimado)

15 de maio de 2028

Conclusão do estudo (Estimado)

30 de agosto de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de julho de 2026

Primeira postagem (Real)

21 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • VALID III
  • 26-12-KU (Outro identificador: Ministry of Foreign Affairs of Denmark (DANIDA))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared due to strict data privacy agreements with partnering hospitals and project data ownership policies. Only aggregated, summary-level data will be made available through project reports and publications

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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