Perinatal Mental HealthHAP3NCT07837193
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
A study testing HAP3 Family App in people with Perinatal Mental Health and Gestational Weight Gain, run by KU Leuven at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Perinatal Mental Health, Gestational Weight Gain, Postpartum Weight Retention
- What is being tested?
- HAP3 Family App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2026to 1 May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- Partners:
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Vrouw en Kind
Leuven, 3000
Lisanne Duizer Duizer, MSc, lisanne.duizer@kuleuven.be
Annick Bogaerts Prof. Dr., Prof. Dr., annick.bogaerts@kuleuven.be
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
The HAP3 intervention is a non-invasive digital health program and is not intended to diagnose, treat, or replace routine medical care. The study is expected to provide important information about the practicality and acceptability of delivering integrated mental health, lifestyle, and parenting support through a digital platform during the transition to parenthood
- Conditions
- Perinatal Mental Health, Gestational Weight Gain, Postpartum Weight Retention, Child Development
- Being tested
- HAP3 Family App
- Keywords
- pregnancy, postpartum, nutrition, child development, intergenerational health, DOHaD, weight management, stress, depression, anxiety, EMA, Digital health, Postpartum Weight Retention, Gestational Weight Gain, Perinatal Mental Health, Feasibility RCT
- Medical subject headings
- Gestational Weight Gain, Developmental Origins of Health and Disease, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAP3 Family AppBehavioural
The 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.
| Study group | Role | What they receive |
|---|---|---|
| HAP3 Family App Intervention | Experimental | 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. Receives: Behavioral: HAP3 Family App |
| Usual Care plus Questionnaire-Only App | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Rate
Percentage of eligible participants who provide informed consent and are enrolled in the study.
Measured: At enrollment (enrollment can be at any gestational age)
Participant Retention Rate
Percentage of enrolled participants who complete the 6-month postpartum assessment.
Measured: From enrollment until 6 months postpartum.
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.
Measured: From enrollment until 6 months postpartum.
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.
Measured: From enrollment until 6 months postpartum.
Motivation for Eating Behavior Change
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.
Measured: Baseline, 32 weeks pregnancy, and 6 months postpartum.
Motivation for Mental Health Behavior Change
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.
Measured: Baseline, 32 weeks pregnancy, and 6 months postpartum.
Secondary outcomes (15)
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.
Measured: Baseline, 32 weeks pregnancy, 6 weeks postpartum, and 6 months postpartum.
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.
Measured: Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.
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.
Measured: Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.
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.
Measured: 32 weeks pregnancy.
Paternal Pregnancy-related Anxiety Scale (PPrAS)
Pregnancy-related anxiety among partners assessed using the Paternal Pregnancy-related Anxiety Scale (PPrAS). Higher scores indicate greater pregnancy-related anxiety.
Measured: 32 weeks pregnancy.
Maternal and Partner Weight
Body weight measured in kilograms (kg) using standardized measurements at study visits and self-reported weight between visits (used for gastational weight gain (GWG) and postpartum weight retention (PPWR))
Measured: Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.
Maternal and Partner Body Composition
Body composition assessed using Bioelectrical Impedance Analysis (BIA).
Measured: Baseline and 6 months postpartum.
Eating Behavior
The Three-Factor Eating Questionnaire-Revised 18-item (TFEQ-R18) evaluates three distinct domains of eating behavior: Cognitive Restraint (6 items evaluating conscious restriction of food intake to control weight), Uncontrolled Eating (9 items evaluating the tendency to lose control over eating when triggered by food cues), and Emotional Eating (3 items evaluating overeating in response to negative mood states). Raw item responses for each subscale are summed and linearly transformed to a standardized 0 to 100 scale. The overall outcome reports three separate subscale scores ranging from 0 to 100, where higher scores indicate greater cognitive control over food intake, a higher tendency to overeat impulsively, or a greater likelihood of eating in response to negative emotions, respectively.
Measured: Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.
Body Image
The Body Image in Pregnancy and Postpartum Scale (BIPPS) evaluates multi-dimensional maternal body image dissatisfaction and physical anxieties distinct to the perinatal period. Individual questionnaire items are scored on a 5-point Likert scale (ranging from 1 to 5) and aggregated to generate an overall composite total score. Total scores range from 20 to 100, where higher scores indicate greater body image concerns, reflecting increased dissatisfaction or distress regarding physical appearance and structural bodily changes during pregnancy or postpartum phases.
Measured: 32 weeks pregnancy and 6 months postpartum.
Infant weight
Infant weight measured in kilograms (kg). Higher values indicate greater infant weight.
Measured: 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.
Infant length
Infant length measured in centimeters (cm). Higher values indicate greater infant length.
Measured: 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.
APGAR Score
Neonatal health status assessed using the APGAR score. Total scores range from 0 to 10, with higher scores indicating better neonatal health and adaptation after birth.
Measured: at birth
Infant Development
Infant development assessed using the Infant Development Inventory (IDI), a parent-reported measure of developmental attainment across the domains of language, self-help, motor, and social development. Higher scores indicate more advanced developmental attainment. The score range depends on the age-specific version administered.
Measured: 6 weeks postpartum, 3 months postpartum, and 6 months postpartum.
Infant temperament
Infant temperament assessed using the Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R VSF) Negative Reactivity Subscale. Scores range from 1 to 7, with higher scores indicating greater infant negative reactivity, including distress, fearfulness, and difficulty in emotional regulation.
Measured: 3 months postpartum.
Body Height
Body height measured in centimeters (cm) using standardized measurement procedures. Higher values indicate greater body height.
Measured: Baseline and 6 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicountry, two-arm, randomized controlled feasibility trial conducted in Belgium, the Netherlands, and Germany. Eligible pregnant women and their partners are randomized in a 1:1 ratio to either the intervention group (HAP3 Family App with coaching and personalized support) or the control group (questionnaire-only app and usual care). Randomization is stratified by study site, and participating couples are randomized as a unit to the same study arm to minimize contamination between groups. The study includes an embedded mixed-methods process evaluation to assess feasibility, acceptability, usability, adherence, recruitment, retention, and study procedures to inform a future definitive effectiveness trial.
- Masking
- None (open label)
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, Technische Universität Dresden, University of Dublin, Trinity College, University of Aarhus
- Responsible party
- Principal investigator, dr. Annick Bogaerts, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837193
- Sponsor's protocol ID
- S71173
- Other IDs
- 101169127
- Acronym
- HAP3
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to external third parties. Data processing and management are strictly restricted to consortium partners under a Joint Controllership Agreement and a Data Processing Agreement to ensure GDPR compliance and protect participant privacy.