Weight, mental health, child development, perinatal period, parenting Weight, mental health, child development, during and after pregnancy period, being a parent
Conditions
Interventions
Intervention: The HAP3 Family App, delivered via the existing m-path platform, contains evidence-based modules on pregnancy and postpartum care, mental health, physical activity, sleep, nutrition, wei
usability is measured using the mHealth App Usability Questionnaire (MAUQ) and short interviews. Motivation and behavioural change are measured for weight management using Self-reported Weight and Per
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: For the pilot study: To be eligible to participate in this study, a pregnant person must (1) be aged 18 years or older, (2) be currently pregnant, (3) have sufficient proficiency in Dutch, German, or English, (4) reside in Belgium, the Netherlands, or Germany, (5) be capable of giving consent.A postpartum person must (1) be aged 18 years or older, (2) be within 6 months after birth, (3) have sufficient proficiency in Dutch, German, or English, (4) reside in Belgium, the Netherlands, or Germany, (5) be capable of giving consent.Partners of a pregnant or postpartum person must (1) be aged 18 years or older, (2) have sufficient proficiency in Dutch, German, or English, (3) reside in Belgium, the Netherlands, or Germany, (5) be capable of giving consent. For the RCT: To be eligible to participate in this study, a person must meet all of the following criteria. The person must (1) be aged 18 years or older, (2) be currently pregnant*, (3) have sufficient proficiency in Dutch, German, or English, (4) reside in Belgium, the Netherlands, or Germany, (5) be capable of giving consent.Partners of the pregnant person* must (1) be aged 18 years or older, (2) have sufficient proficiency in Dutch, German, or English, (3) reside in Belgium, the Netherlands, or Germany, (5) be capable of giving consent.* As this is a feasibility trial, our primary aim is to recruit the majority of pregnant people before 16 weeks of pregnancy to capture early developmental windows. Nevertheless, to ensure feasibility and to reflect real-world recruitment conditions, we will include women (and their partners) at any stage of pregnancy.
Exclusion criteria
Exclusion criteria: For the pilot study: A potential participant, either a pregnant person, a postpartum person or partners, who meets any of the following criteria will be excluded from participation in this study: (1) current suicidal ideation, (2) severe diagnosed mental health disorders (e.g., bipolar disorder, schizophrenia, borderline personality disorder), (3) Severely debilitating physical health conditions (e.g., advanced cardiovascular or respiratory disease or active cancer or severe hyperemesis gravidarum) that substantially affect daily functioning, (4) history of or planned bariatric surgery during the time of the study, (5) no signed informed consent, or (6) current or planned enrollment in another clinical trial. For the RCT: A potential participant, either a pregnant person or partner, who meets any of the following criteria will be excluded from participation in this study: (1) current suicidal ideation, (2) severe mental health disorders (e.g., bipolar disorder, schizophrenia, borderline personality disorder,) (3) Severely debilitating physical health conditions (e.g., advanced cardiovascular or respiratory disease or active cancer or severe hyperemesis gravidarum) that substantially affect daily functioning, (4) history of or planned bariatric surgery during the time of the study, (5) no signed informed consent, or (6) current or planned enrollment in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study parameters: Primary feasibility parameters include recruitment and retention rates, protocol adherence, app engagement, data completeness, and participant-reported acceptance and usability. | — |
Secondary
| Measure | Time frame |
|---|---|
| Study parameters: Secondary parameters include maternal and partner mental health, eating behaviour, body composition including weight, and child development, measured using validated questionnaires, anthropometric measurements, and EMA questions about mood, nutrition, sleep, and stress. | — |
Countries
Belgium, Germany, Netherlands
Contacts
Public ContactM Oosterman
Vrije Universiteit
Outcome results
None listed