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

NCT03454958 | Completed

• 1 other identifier: G033418N
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 4

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.

Conditions

Body Weight; Health Behavior; Pregnancy; First Pregnancy

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Drop out

  at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum

• Socio-demographics

  at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum

• Breastfeeding

  at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum

• Lifestyle behavior

  at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum

• Postnatal Depression

  at 12 weeks of pregnancy, at 6 weeks postpartum, at 6 months postpartum, at 12 months postpartum

Study Arms (1)

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

Interventions

Measurements of body composition OTHER

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.

Data collection

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Couples (both men and women) will be recruited
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Couples expecting their first child

You may qualify if:

• 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

You may not qualify if:

• 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,…).

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• KU Leuven: collaborator

Study Sites (4)

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

UZ Brussel

Jette, Belgium

Location

UZ Gasthuisberg

Leuven, Belgium

Location

Related Publications (3)

• Versele V, Stas L, Aerenhouts D, Deliens T, Matthys C, Gucciardo L, Devlieger R, Clarys P, Bogaerts A. Dietary intake, physical activity and sedentary behavior and association with BMI during the transition to parenthood: a prospective dyadic study. Front Public Health. 2023 Jun 2;11:1092843. doi: 10.3389/fpubh.2023.1092843. eCollection 2023.

  PMID: 37333547 DERIVED

• 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.

  PMID: 36148362 DERIVED

• 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.

  PMID: 31060535 DERIVED

MeSH Terms

Conditions

Body Weight; Health Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 6, 2018
• Study Start: May 25, 2018
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)