Pregnancy Clinical Trial
— TRANSPARENTSOfficial title:
Body Weight, Body Composition and Energy Balance Related Behavior During the Transition to Parenthood
NCT number | NCT03454958 |
Other study ID # | G033418N |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 25, 2018 |
Est. completion date | July 13, 2020 |
Verified date | November 2020 |
Source | Vrije Universiteit Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Understanding critical periods during which people are at risk to gain weight or display unhealthy changes in energy balance related behaviour, i.e. eating, physical activity and sedentary behaviour, can facilitate the development of weight gain prevention programs. Although the transition to parenthood is associated with pregnancy-related weight gain and retention in women, evidence on the effect of having a first child on men's body weight is lacking. It is also unclear whether pregnancy-related weight gain and retention cohere with unfavourable changes in body composition and energy balance related behaviour in both women and men transitioning to parenthood. Using a mixed-methods design, the investigators aim to provide insight into this critical life phase. An observational follow-up study will be used to investigate changes in body weight, body composition and energy balance related behaviour among couples from pre-conception to one year postpartum, and to identify those most at risk for excessive weight gain.
Status | Completed |
Enrollment | 304 |
Est. completion date | July 13, 2020 |
Est. primary completion date | July 13, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Couples expecting their first child (nulliparous women and men) - Participants aged =18 years - Participants with any BMI - Participants from any socio-economic status (SES) - Participants have a sufficient proficiency of the Dutch language Exclusion Criteria: - Participants unable or unwilling to give informed consent - Participants below 18 years of age - Participants not speaking the Dutch language - Participants suffering from a pathological condition that may influence energy balance related behaviour (e.g. diabetes,), with significant psychiatric disorder, with history of a bariatric surgery, or with requirements for complex medical diets. - Participants who are - because of medical or other specific reasons - not allowed to exercise (e.g. bed-rest). - Women having a multiple pregnancy (twin, triplet,…). |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg | Genk | |
Belgium | Jessa Ziekenhuis | Hasselt | |
Belgium | UZ Brussel | Jette | |
Belgium | UZ Gasthuisberg | Leuven |
Lead Sponsor | Collaborator |
---|---|
Vrije Universiteit Brussel | KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in BMI | Maternal and paternal body weight and height from which BMI will be calculated | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Primary | Change in body composition | Body composition measured by bio-electrical impedance analysis to estimate fat mass, fat free mass and muscle mass | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Primary | Change in body fat | Skin fold measurements for determing body fat composition by use of a skinfold calliper. | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Primary | Changes in dietary intake | A Food Frequency Questionnaire (FFQ) will be used for assessing dietary intake. | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Primary | Change in energy expenditure | Tri-axial accelerometers (Actigraph) will be used to measure energy expenditure (by ratio of physical activity and sedentary behaviour) objectively over a one-week period. | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Primary | Change in physical activity | Physical activity will be assessed using a self-reported questionnaire (International Physical Activity Questionnaire (IPAQ - Dutch version) and context-specific sedentary behavior. | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Primary | Change in sedentary behaviour | Sedentary behaviour will be assessed using a context-specific sedentary behavior questionnaire. | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Secondary | Drop out | Drop out analysis by using statistical program (SPSS) | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Secondary | Socio-demographics | Self-reported questionnaire | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Secondary | Breastfeeding | Self-reported questionnaire | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Secondary | Lifestyle behavior | Self-reported questionnaire | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Secondary | Postnatal Depression | Self-reported 23-item questionnaire | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Secondary | Partner support | Self-reported questionnaire for social support from partner about eating and physical activity behaviour | at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum | |
Secondary | New-borns anthropometrics | Anthropometric measurements to determin new-borns body fat composition | at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum |
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