出生前の絆：初めて妊娠したカップルのための mHealth 介入 (B³)
誕生前の絆：妊娠中のカップル向けマインドフルネスと感情調節を育むクラスター無作為化比較対照mHealth試験
Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms.
This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control.
Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health.
Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.
調査の概要
詳細な説明
The overall goal of this study is to answer the following main questions:
- Does the intervention improve parents' depressive symptoms scores, using the Edinburgh Postnatal Depression Scale as a proxy?
- Does the intervention improve parents' emotional regulation skills?
The study involves 286 expectant couples (572 individuals) in a two-arm, cluster-randomized controlled trial with longitudinal observational follow-up until the child turns 6 months old. The active intervention comprises of customized, weekly recommendations of short (2-5 minute) audio clips featuring activities such as breathing exercises, meditation, mindful walking. These will be provided to adult participants (expectant couples). Couples enrolling in the study will randomly be allocated to either the control or intervention group by prespecified block sizes of 10. That is, a random number generator will be used to preset the assignments in groups of 10, such that every 10 consecutive enrolments will have exactly 5 controls and 5 interventions (1:1 allocation). While it is not possible to blind operational staff to assignments (different protocols to follow, highly unbalanced assignment), scheduling of enrolment visits will be done by different staff than those conducting the enrolment visits, and the assignment will only be made known to enrolment staff while conducting the visit itself and they will also not have access to the blocking and randomization algorithm.
Participants in the control, no-intervention group will have access to a mobile app with similar functions as the participants in the intervention group, except that no personalized modules are given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
Participants in the intervention group will have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Participants will also be re-randomized weekly to different modules within the app. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
The intervention will take place throughout pregnancy, beginning at enrollment ( when the mother is less than 20 gestational weeks of pregnancy), and continuing until the child is born. As gestational duration varies among participants, the total intervention period will range approximately from 17 to 28 weeks, depending on the timing of recruitment and delivery. All study arms will be assessed up to 6 months after birth.
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：Santhi Ponmudi, MPh
- 電話番号：+65-64070100
- メール：santhi_ponmudi@a-star.edu.sg
研究場所
-
-
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Singapore、シンガポール、117609
- 募集
- Institute for Human Development and Potential (IHDP), Singapore
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コンタクト：
- Santhi Ponmudi, MPh
- 電話番号：+65-64070100
- メール：santhi_ponmudi@a-star.edu.sg
-
主任研究者：
- Michelle Z.L Kee, PhD
-
主任研究者：
- Cornelia Y.I Chee, MBBS, MMed
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主任研究者：
- Bibhas Chakraborty, PhD
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副調査官：
- Xiaoxi Yan, PhD
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副調査官：
- Evelyn C Law, MD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Mothers:
- 21-50 years of age
- Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment
- Singleton pregnancy
- Nulliparous
- Plan to deliver in Singapore
- Proficient and able to respond to questionnaires in English
- Intends for herself and her child to stay in Singapore for the next 2 years
- Access to a smartphone
- Willing to download the study app
- Score of 7 or more in the Edinburgh Postnatal Depression Scale
Fathers:
- 21-75 years of age
- Proficient and able to respond to questionnaires in English
- Intends for himself and his child to stay in Singapore for the next 2 years
- Access to a smartphone
- Willing to download the study app
Exclusion Criteria:
Mothers:
- Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders
- Currently on oral/IV steroids and/or thyroid medication
- History of thyroid disease
- Pregnant using assisted reproductive technologies
- Multiple pregnancies
- Currently enrolled in interventional randomised controlled trials
- Responded "Yes, quite often" to EPDS item 10 ("The thought of harming myself has occurred to me")
Fathers:
1. Currently enrolled in interventional randomised controlled trials
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：処理
- 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 |
|---|---|
|
介入なし：Group A (Control)
Participants' will have access to a mobile app with similar functions as the participants in the intervention group, except that there are no personalized modules given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. |
|
|
実験的：Group B (Intervention)
Participants have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. |
Participants in the intervention group will receive recommended modules in the mHealth app installed on their phones. |
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 |
|---|---|---|
|
Parents' Depressive Symptoms
時間枠：Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. The average of the three postnatal EPDS measurements will be used as the primary outcome assessment
|
Parents' level of depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale. |
Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. The average of the three postnatal EPDS measurements will be used as the primary outcome assessment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parents' emotional regulation skills
時間枠：Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months.
|
Examining self-reported parental emotional regulation skills using the Cognitive Emotion Regulation Questionnaire |
Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months.
|
協力者と研究者
捜査官
- 主任研究者：Michelle Z.L Kee, PhD、Institute for Human Development and Potential
研究記録日
主要日程の研究
研究開始 (実際)
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
その他の研究ID番号
- 2026-049
- H22P0M0001 (その他の助成金/資金番号：A*STAR Human Health and Potential Prenatal/Early Childhood Grant)
- H22P0M0009 (その他の助成金/資金番号：A*STAR Human Health and Potential Prenatal/Early Childhood Grant)
- NUHSRO/2025/082/NUSMed/024/B3 (その他の助成金/資金番号：National University of Singapore)
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
The decision regarding the availability of individual participant data for sharing requires further discussions between the institutes.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。