Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Healthy Habits During and After Gestational Diabetes (VALID III)

20. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2546

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Thanh Duc Nguyen, Assoc. Prof
  • Telefonnummer: +84 91 235 7575
  • E-mail: bsthanh@hotmail.com

Studiesteder

  • Vietnam
    • Hưng Yên Province
      • Thái Bình, Hưng Yên Province, Vietnam
        • Thai Binh University of Medicine and Pharmacy
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Adfærdsmæssigt: 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
Aktiv komparator: Standard Care + Web Access
Access to a website with GDM management + standard care
Adfærdsmæssigt: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of exclusive breastfeeding
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Secondary outcome: Proportion of exclusive breastfeeding at 180 days (6 months) after birth
Tidsramme: 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
Tidsramme: 24 months after birth
Fat Mass Index (FMI)= Fat mass (kg)/height (m2)
24 months after birth

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal long-term metabolic health
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Thai Binh University of Medicine and Pharmacy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. november 2026

Primær færdiggørelse (Anslået)

15. maj 2028

Studieafslutning (Anslået)

30. august 2030

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med GDM

Kliniske forsøg med Hybrid intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Congo, DR of

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner