Healthy Habits During and After Gestational Diabetes (VALID III)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Thanh Duc Nguyen, Assoc. Prof
- 電話番号：+84 91 235 7575
- メール：bsthanh@hotmail.com
研究場所
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Hưng Yên Province
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Thái Bình、Hưng Yên Province、ベトナム
- Thai Binh University of Medicine and Pharmacy
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コンタクト：
- Thanh Duc Nguyen, Phd
- 電話番号：+84 91 235 7575
- メール：bsthanh@hotmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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
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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 |
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アクティブコンパレータ：Standard Care + Web Access
Access to a website with GDM management + standard care
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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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Duration of exclusive breastfeeding
時間枠：Day 1-180 after birth
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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
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Day 1-180 after birth
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Secondary outcome: Proportion of exclusive breastfeeding at 180 days (6 months) after birth
時間枠：180 days (6 months) after birth
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Proportion of exclusive breastfeeding (as defined above) at 180 days after birth.
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180 days (6 months) after birth
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Child fat mass index (FMI) at 24 months after birth
時間枠：24 months after birth
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Fat Mass Index (FMI)= Fat mass (kg)/height (m2)
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24 months after birth
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Maternal long-term metabolic health
時間枠：24 months after birth.
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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).
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24 months after birth.
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Maternal Informal social support
時間枠：Baseline (24-28 weeks' gestation, at the time of the oral glucose tolerance test [OGTT]), 6, 12, and 24 months after birth
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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.
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Baseline (24-28 weeks' gestation, at the time of the oral glucose tolerance test [OGTT]), 6, 12, and 24 months after birth
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Maternal quality of life
時間枠：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
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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
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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
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Child socio-emotional development
時間枠：At 6, 12 and 24 months after birth
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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
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At 6, 12 and 24 months after birth
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Child fat mass
時間枠：At 6, 12, and 24 months after birth
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Child fat mass and fat-free mass
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At 6, 12, and 24 months after birth
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Maternal glycaemic control in pregnancy
時間枠：Baseline (at diagnosis of gestational diabetes mellitus during 24-28 weeks of gestation) and at delivery
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HbA1c (glycated haemoglobin) reflects the average blood glucose concentration over the past ~8-12 weeks and is measured from a blood sample
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Baseline (at diagnosis of gestational diabetes mellitus during 24-28 weeks of gestation) and at delivery
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- VALID III
- 26-12-KU (その他の識別子：Ministry of Foreign Affairs of Denmark (DANIDA))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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