Body Weight, Body Composition and Energy Balance Related Behavior During the Transition to Parenthood (TRANSPARENTS)

• ClinicalTrials.gov Identifier: NCT03454958
• Recruitment Status: Completed
• First Posted: March 6, 2018
• Last Update Posted: November 13, 2020
• Sponsor: Vrije Universiteit Brussel
• Collaborator: KU Leuven
• Information provided by (Responsible Party): Vicka Versele, Vrije Universiteit Brussel

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Body Weight; Health Behavior; Pregnancy; First Pregnancy	Other: Measurements of body composition

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 Design

• Study Type: Observational
• Actual Enrollment: 304 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Body Weight, Body Composition and Energy Balance Related Behavior During the Transition to Parenthood
• Actual Study Start Date: May 25, 2018
• Actual Primary Completion Date: July 13, 2020
• Actual Study Completion Date: July 13, 2020

Groups and Cohorts

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).

Other: Measurements of body composition; 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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

Secondary Outcome Measures :

1. 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)
2. Socio-demographics [ Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum ]
   Self-reported questionnaire
3. Breastfeeding [ Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum ]
   Self-reported questionnaire
4. Lifestyle behavior [ Time Frame: at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum ]
   Self-reported questionnaire
5. 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
6. 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
7. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Couples (both men and women) will be recruited
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Couples expecting their first child

Criteria

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,…).

Contacts and Locations

Locations

Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

UZ Brussel

Jette, Belgium

UZ Gasthuisberg

Leuven, Belgium

Sponsors and Collaborators

Vrije Universiteit Brussel

KU Leuven

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Vicka Versele, PhD student, Vrije Universiteit Brussel
• ClinicalTrials.gov Identifier: NCT03454958
• Other Study ID Numbers: G033418N
• First Posted: March 6, 2018
• Last Update Posted: November 13, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Body Weight