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.
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.
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.
Parallel
HAP3 Family App
BehavioralThe HAP3 Family App is a multicomponent digital behavioral intervention designed specifically for pregnant women and their partners during pregnancy and the first six months postpartum. The intervention combines self-monitoring, self-management, evidence-based educational modules, Ecological Momentary Assessments (EMA), personalized dashboard messages, and structured video/telephone coaching. Content addresses multiple interconnected domains including mental well-being, healthy eating, physical activity, sleep, healthy weight management, pregnancy and postpartum care, parenting, and child development. Unlike interventions that focus on a single health outcome, the HAP3 intervention provides integrated support for both physical and mental health and actively involves partners. The intervention is delivered through a mobile application and supported by a dashboard that enables tailored feedback and coaching based on participant engagement and self-reported experiences.
Participant Recruitment Rate
Percentage of eligible participants who provide informed consent and are enrolled in the study.
Participant Retention Rate
Percentage of enrolled participants who complete the 6-month postpartum assessment.
HAP3 Family App Acceptability
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
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.
Edinburgh Postnatal Depression Scale (EPDS)
Depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS). Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.
6-item State-Trait Anxiety Inventory (STAI-6)
Anxiety symptoms assessed using the 6-item State-Trait Anxiety Inventory (STAI-6). Scores range from 20 to 80 after score transformation, with higher scores indicating greater anxiety.
Depression Anxiety Stress Scales, Stress Subscale (DASS-21)
tress symptoms assessed using the Stress subscale of the Depression Anxiety Stress Scales-21 (DASS-21). Subscale scores range from 0 to 42 after standard scoring, with higher scores indicating greater stress.
Pregnancy-related Anxiety Questionnaire-Revised 2 (PRAQ-R2)
Assessed using the Pregnancy-related Anxiety Questionnaire-Revised 2 (PRAQ-R2). The PRAQ-R2 is a 10-item self-report questionnaire scored on a 5-point Likert scale. Total scores are calculated by summing all items and range from a minimum of 10 to a maximum of 50. Higher scores indicate greater pregnancy-related anxiety.
Health, Lifestyle, and Parenting-Related Outcomes
Exploratory assessment of factors associated with parental and child well-being, including sleep quality, physical activity, social support, body image, eating behaviors, parent-child bonding, parental self-efficacy, and birth-related post-traumatic stress symptoms using validated questionnaires (PSQI, PPAQ, OSSS-3, BIPPS, TFEQ, PPBS, SENR, and City BiTS-SF).
Sleep Quality
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. A global score \>5 is commonly used to indicate poor sleep quality.
Physical activity
Physical activity assessed using the Pregnancy Physical Activity Questionnaire-Short Form (PPAQ-SF). Scores are calculated as Metabolic Equivalent of Task (MET)-hours per week across activity domains. Higher scores indicate greater physical activity levels. No fixed minimum or maximum score is defined because scores depend on the participant's reported activity.
Social support
Social support assessed using the Oslo Social Support Scale (OSSS-3). Total scores range from 3 to 14, with higher scores indicating greater perceived social support. Scores of 3-8 indicate poor support, 9-11 indicate moderate support, and 12-14 indicate strong support.
Click on the lead sponsor to view all of their trials.
KU Leuven
Lead sponsor
VU University of Amsterdam
Collaborator
Technische Universität Dresden
Collaborator
University of Dublin, Trinity College
Collaborator
University of Aarhus
Collaborator
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