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

Pregnancy Clinical Trial

— TRANSPARENTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454958
• Other study ID #: G033418N
• Status: Completed
• Start date: May 25, 2018
• Est. completion date: July 13, 2020

Study information

• Verified date: November 2020
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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,…).

Related Conditions & MeSH terms

• Body Weight
• First Pregnancy
• Health Behavior
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	UZ Brussel	Jette
Belgium	UZ Gasthuisberg	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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