- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03454958
Body Weight, Body Composition and Energy Balance Related Behavior During the Transition to Parenthood (TRANSPARENTS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The first objective of this research is to investigate both maternal and paternal changes in body weight, body composition and energy balance related behaviour during and after pregnancy in Flemish couples.
The second objective is to investigate socio-demographic and behavioural predictors of changes in both maternal and paternal body weight and body composition, in order to identify those most at risk for postpartum weight gain and retention.
Couples transitioning into parenthood (age ≥ 18 years, any BMI and socio-economic status) will be recruited during the first trimester of pregnancy by gynaecologists from the partner obstetrics units at five Flemish hospitals. All couples expecting their first child will be asked to participate in the study. Participants below 18 years of age, not speaking the Dutch language or suffering from a pathological condition that may influence energy balance related behaviour (e.g. diabetes, preeclampsia etc.) will be excluded.
Using a longitudinal design, participating couples (women and men) will be measured four times over the course of approximately one year and nine months. Baseline measurements (T0) will take place during the first trimester of pregnancy (at 12 weeks of pregnancy), with follow-up measurements at respectively six weeks (T1), and six (T2) and twelve months (T3) postpartum.
At baseline (T0), both retrospective and prospective measurements will be conducted in both pregnant women and men expecting their first child. Retrospectively, a self-report questionnaire will be used to assess body weight, height and energy balance related behaviour, incl. eating (Food Frequency Questionnaire (FFQ) which will be adapted for pregnant women), physical activity (International Physical Activity Questionnaire (IPAQ - Dutch version) and sedentary behaviour. The self-report questionnaire will also include questions about sleeping habits, smoking, and socio-demographics. Prospectively, body weight (SECA digital weighing scale), height (SECA stadiometer), body composition (TANITA Bioelectrical Impedance Analyzer & skin fold thickness measurements at the biceps, triceps, subscapular and suprailiac sites) and waist circumference (Cescorf measuring tape) will be objectively measured. Women's gestational weight will be monitored by the gynaecologists as all pregnant women are being weighed during consultation. The same self-report questionnaire (see supra) will be used prospectively, including extra questions about breastfeeding and parental leave. In addition, dietary intake will be assessed by a 3-day food diary, whereas tri-axial accelerometers (Actigraph) will be used to measure energy expenditure (by rate of physical activity and sedentary behaviour) objectively over a one-week period. At followup moments (T1-3), the same aforementioned prospective measurements will be carried out.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Genk, Belgium
- Ziekenhuis Oost-Limburg
-
Hasselt, Belgium
- Jessa Ziekenhuis
-
Jette, Belgium
- UZ Brussel
-
Leuven, Belgium
- UZ Gasthuisberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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,…).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Data collection
Data will be collected at four time points over the course of approximately one year and nine months.
Participating couples (women and men) will be recruited during the first trimester of their first pregnancy.
First measurement will take place in the week of the first routine ultrasound scan (week 12 of pregnancy) (=T0).
First follow-up measures will take place six weeks postpartum (=T1).
The second and third follow-up measurements will take place at six months postpartum (=T2) and twelve months postpartum (=T3).
|
Body weight (SECA digital weighing scale), height (SECA stadiometer), body composition (TANITA Bioelectrical Impedance Analyzer & skin fold thickness measurements at the biceps, triceps, subscapular and suprailiac sites) and waist circumference (Cescorf measuring tape) will be objectively measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in BMI
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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
|
Change in body composition
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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
|
Change in body fat
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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
|
Changes in dietary intake
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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
|
Change in energy expenditure
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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
|
Change in physical activity
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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
|
Change in sedentary behaviour
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drop out
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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
|
Socio-demographics
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Self-reported questionnaire
|
at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Breastfeeding
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Self-reported questionnaire
|
at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Lifestyle behavior
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Self-reported questionnaire
|
at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Postnatal Depression
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Self-reported 23-item questionnaire
|
at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Partner support
Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
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
|
New-borns anthropometrics
Time Frame: at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Anthropometric measurements to determin new-borns body fat composition
|
at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Versele V, Bogaerts A, Devlieger R, Matthys C, Gucciardo L, Deliens T, Clarys P, Aerenhouts D. Association between perceived partner support and lifestyle in mother-father dyads expecting a first child. Front Public Health. 2022 Sep 6;10:912768. doi: 10.3389/fpubh.2022.912768. eCollection 2022.
- Deliens T, Versele V, Vanden Eynde H, Clarys P, Devlieger R, Bogaerts A, Gucciardo L, Schreurs A, Van Holsbeke C, Aerenhouts D. Body weight, body composition and energy balance related behaviour during the transition to parenthood: study protocol of a multi-centre observational follow-up study (TRANSPARENTS). BMC Public Health. 2019 May 6;19(1):516. doi: 10.1186/s12889-019-6884-0.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G033418N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Weight
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingWeight Loss | Weight, BodyUnited States
-
Oslo University HospitalMayo Clinic; Sorlandet Hospital HF; The Hospital of Vestfold; University of TwenteActive, not recruiting
-
Fred Hutchinson Cancer CenterCompletedWeight Loss | Weight, BodyUnited States
-
Pusan National University HospitalCompletedWeight Change, Body
-
Xinhua Hospital, Shanghai Jiao Tong University...Not yet recruiting
-
Erik Ramirez LopezCompletedWeight Loss | Body CompositionMexico
-
University of LeedsDietary Assessment LtdRecruitingWeight Loss | Colorectal Surgery | Weight Change, Body | Gastroenterology SurgeryUnited Kingdom
-
University of TennesseeMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases...CompletedSmoking Cessation | Weight Change, BodyUnited States
-
Virta HealthActive, not recruiting
-
University of CopenhagenCompleted
Clinical Trials on Measurements of body composition
-
Medical University of ViennaUnknownBody Composition | UltrasoundAustria
-
Tufts Medical CenterCompleted
-
Tianjin Medical University Cancer Institute and...Recruiting
-
Aalborg University HospitalCompleted
-
University of California, Los AngelesCompletedHeart Failure | ObesityUnited States
-
University of Alabama at BirminghamNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingBody Weight | Adiposity | Infant,PrematureUnited States
-
United States Army Research Institute of Environmental...Recruiting
-
University of MinnesotaBaystate Medical Center; Santa Clara Valley Medical CenterCompletedPreterm Birth
-
Universitair Ziekenhuis BrusselTerminatedHIV-1 | Treatment-naïveBelgium
-
Pennington Biomedical Research CenterTanitaCompletedBody Composition | Circumference Measurements | Tissue Thickness MeasurementsUnited States