Healthy Adaptation to Pregnancy, Postpartum and Parenthood (HAP3) Feasibility Study of the HAP3 Family App and Dashboard Targeting Health Behaviours for Weight and Mental Health in Women, Partners, and Offspring During Pregnancy and Postpartum
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- KU Leuven
- 入组人数
- 572
- 试验地点
- 1
- 主要终点
- Participant Recruitment Rate
研究概览
简要总结
Healthy Adaptation to Pregnancy, Postpartum and Parenthood (HAP3) The HAP3 study is evaluating a new digital support program for pregnant women and their partners. The program includes the HAP3 Family App, which provides information and practical tools on healthy eating, physical activity, sleep, emotional well-being, pregnancy and postpartum care, healthy weight management, parenting, and child development.
Researchers want to find out whether the app is easy to use, acceptable to families, and practical to implement during pregnancy and after birth. The study will also explore whether using the app may help improve parents' mental well-being, healthy lifestyle habits, weight management, and early child development.
Participants will be randomly assigned to one of two groups. One group will receive access to the full HAP3 Family App, personalized coaching by phone or video call, and supportive messages. The other group will receive usual care and use the app only to complete study questionnaires.
The study will follow families from pregnancy until six months after birth. Participants will complete questionnaires about their health, well-being, and parenting experiences. Those using the full app will also be asked to complete brief in-app check-ins about mood, sleep, stress, and daily habits.
The HAP3 intervention is not a medical treatment and involves minimal risk. Potential benefits include increased awareness of health behaviors, access to evidence-based information, and support during the transition to parenthood.
The study is being conducted by researchers from KU Leuven (Belgium), Vrije Universiteit Amsterdam (Netherlands), and Technische Universität Dresden (Germany) as part of the European HAP3 project.
详细描述
The Healthy Adaptation to Pregnancy, Postpartum and Parenthood (HAP3) study is a multicountry randomized controlled feasibility trial evaluating a digital intervention designed to support pregnant women and their partners during pregnancy and the first six months after birth. The study is conducted in Belgium, the Netherlands, and Germany.
The intervention consists of the HAP3 Family App and a supporting Dashboard used by the study team. The app provides evidence-based information and self-management tools covering nutrition, physical activity, sleep, emotional well-being, healthy weight management, pregnancy and postpartum care, parenting, and child development. Participants can engage with educational and interactive content tailored to their stage of pregnancy or postpartum period.
Participants assigned to the intervention group will have access to the full HAP3 Family App, brief video or telephone coaching sessions, personalized messages, and short in-app assessments that capture daily experiences such as mood, stress, sleep, appetite, and physical activity. Participants assigned to the control group will receive usual care and use a questionnaire-only version of the app.
The primary aim of the study is to evaluate the feasibility, usability, acceptability, and implementation of the HAP3 intervention and study procedures. This includes assessing recruitment and retention rates, participant engagement with the app, adherence to study procedures, data completeness, and user experiences.
Secondary objectives are exploratory and focus on potential effects of the intervention on parental mental well-being, healthy lifestyle behaviors, weight management, and early child development. Outcomes assessed include symptoms of anxiety, depression, stress, eating behavior, sleep quality, physical activity, social support, parent-child bonding, parental self-efficacy, and infant development during the first six months of life.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant person aged 18 years or older.
- •Currently pregnant (participants may be recruited at any stage of pregnancy, -although recruitment before 16 weeks of pregnancy is preferred).
- •Sufficient proficiency in Dutch, German, or English.
- •Resident of Belgium, the Netherlands, or Germany.
- •Able and willing to provide informed consent.
- •Partner of an eligible pregnant participant.
- •Aged 18 years or older.
- •Sufficient proficiency in Dutch, German, or English.
- •Resident of Belgium, the Netherlands, or Germany.
- •Able and willing to provide informed consent.
排除标准
- •Current suicidal ideation.
- •Severe mental health disorder (e.g., bipolar disorder, schizophrenia, borderline personality disorder).
- •Severely debilitating physical health condition that substantially affects daily functioning (e.g., advanced cardiovascular disease, advanced respiratory disease, or active cancer).
- •History of or planned bariatric surgery during the study period.
- •Failure or unwillingness to provide informed consent.
- •Current participation or planned enrollment in another clinical trial that may conflict with this study.
研究组 & 干预措施
Usual Care plus Questionnaire-Only App
Participants receive usual perinatal care and access to a restricted version of the app used only for study questionnaires. They do not receive intervention modules, EMA, personalized messages, or coaching.
HAP3 Family App Intervention
Participants receive access to the full HAP3 Family App, including evidence-based modules on mental health, nutrition, physical activity, sleep, weight management, pregnancy and postpartum care, parenting, Ecological Momentary Assessments (EMA), personalized dashboard messages, and video/phone coaching in addition to usual care.
干预措施: HAP3 Family App (Behavioral)
结局指标
主要结局
Participant Recruitment Rate
时间窗: At enrollment (enrollment can be at any gestational age)
Percentage of eligible participants who provide informed consent and are enrolled in the study.
Participant Retention Rate
时间窗: From enrollment until 6 months postpartum.
Percentage of enrolled participants who complete the 6-month postpartum assessment.
HAP3 Family App Acceptability
时间窗: From enrollment until 6 months postpartum.
Acceptability assessed using a study-specific questionnaire developed for the HAP3 feasibility study and informed by the Attitudes towards Psychological Online Interventions Questionnaire (APOI). The questionnaire evaluates participants' perceptions, satisfaction, and acceptance of the HAP3 Family App. Higher scores indicate greater acceptability of the intervention. The questionnaire is currently undergoing psychometric evaluation and has not yet been formally validated.
HAP3 Family App Usability
时间窗: From enrollment until 6 months postpartum.
Usability measured using the mHealth App Usability Questionnaire (MAUQ). Scores range from 1 (Strongly agree) to 7 (Strongly disagree). A higher overall mean score (closer to 7.0) indicates a more favorable evaluation of the mobile health application's usability.
Motivation for Eating Behavior Change
时间窗: Baseline, 32 weeks pregnancy, and 6 months postpartum.
Behavioural Change Towards Eating Behaviour (IBEB) questionnaire, a study-specific measure based on the Stages of Change framework. Higher scores indicate greater readiness and motivation to adopt healthy eating behaviors. A total score is calculated from the questionnaire items; score range will be determined following validation of the instrument.
Motivation for Mental Health Behavior Change
时间窗: Baseline, 32 weeks pregnancy, and 6 months postpartum.
Evaluated using the University of Rhode Island Change Assessment (URICA) scale. The URICA is a 32-item questionnaire scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). It measures four subscales representing stages of behavior change: Precontemplation, Contemplation, Action, and Maintenance. A composite Readiness to Change score is calculated using the formula: Contemplation + Action + Maintenance - Precontemplation. Composite scores typically range from a minimum of -2 to a maximum of 14. Higher composite scores indicate a greater readiness and overall motivation to change the target behavior.
次要结局
- Edinburgh Postnatal Depression Scale (EPDS)(Baseline, 32 weeks pregnancy, 6 weeks postpartum, and 6 months postpartum.)
- 6-item State-Trait Anxiety Inventory (STAI-6)(Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Depression Anxiety Stress Scales, Stress Subscale (DASS-21)(Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Pregnancy-related Anxiety Questionnaire-Revised 2 (PRAQ-R2)(32 weeks pregnancy.)
- Paternal Pregnancy-related Anxiety Scale (PPrAS)(32 weeks pregnancy.)
- Maternal and Partner Weight(Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Maternal and Partner Body Composition(Baseline and 6 months postpartum.)
- Eating Behavior(Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Body Image(32 weeks pregnancy and 6 months postpartum.)
- Infant weight(6 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Infant length(6 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- APGAR Score(at birth)
- Infant Development(6 weeks postpartum, 3 months postpartum, and 6 months postpartum.)
- Infant temperament(3 months postpartum.)
- Body Height(Baseline and 6 months postpartum.)