Healthy Adaptation to Pregnancy, Postpartum and Parenthood

NCT07837193 | Not Yet Recruiting

• 2 other identifiers: S71173101169127
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Perinatal Mental Health; Gestational Weight Gain; Postpartum Weight Retention; Child Development

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

Outcome Measures

Primary Outcomes (6)

• Participant Recruitment Rate

  Percentage of eligible participants who provide informed consent and are enrolled in the study.

  At enrollment (enrollment can be at any gestational age)

• Participant Retention Rate

  Percentage of enrolled participants who complete the 6-month postpartum assessment.

  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.

  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.

  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.

  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.

  Baseline, 32 weeks pregnancy, and 6 months postpartum.

Secondary Outcomes (15)

• 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.

Other Outcomes (9)

• Health, Lifestyle, and Parenting-Related Outcomes

  Baseline, 32 weeks pregnancy, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum, depending on the specific measure.

• Sleep Quality

  32 weeks pregnancy, 6 weeks postpartum, and 6 months postpartum.

• Physical activity

  Baseline, 32 weeks pregnancy, and 6 months postpartum

Study Arms (2)

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.

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.

Interventions

HAP3 Family App BEHAVIORAL

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.

HAP3 Family App Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• VU University of Amsterdam: collaborator
• Technische Universität Dresden: collaborator
• University of Dublin, Trinity College: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Vrouw en Kind

Leuven, 3000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Gestational Weight Gain; Developmental Origins of Health and Disease; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prenatal Exposure Delayed Effects; Prenatal Injuries; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Annick Bogaerts Prof. Dr., Prof. Dr.

CONTACT

Annick Bogaerts; annick.bogaerts@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)