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Clinical Trials/NCT05621109
NCT05621109
Recruiting
Not Applicable

PRE-Pregnancy Weight Loss and the Reducing Effect on CHILDhood Overweight - a Randomized Controlled Study in Copenhagen

Christian Mølgaard1 site in 1 country480 target enrollmentStarted: December 15, 2022Last updated:
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ConditionsOverweight and ObesityWeight LossPregnancy Related

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Christian Mølgaard
Enrollment
480
Locations
1
Primary Endpoint
Neonatal fat mass
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The study is a single site parallel randomized controlled study.

The study will be assessing the effect of approximately 10% weight loss intervention vs a control group among healthy females/couples where the prospective mother is overweight or obese (BMI 27-45 kg/m^2) and between 18-38 years. The investigators will recruit a total of 240 healthy females/couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI.

The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight and adiposity and its complications compared to a control group. The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a reduction in offspring neonatal adiposity, reduced risk of being born large for gestational age (LGA) and with lower BMI z-score at 18 months.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to 38 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Planning pregnancy within 1 year
  • •Provided voluntary informed consent
  • •Danish or English speaking
  • •Intention to permit the planned offspring to participate in the follow-up study
  • •Able to store biological samples from the offspring at home in the freezer in a box given by the study personnel

Exclusion Criteria

  • •Diabetes mellitus (Type 1 or 2)
  • •Previous or present eating disorder
  • •Allergy towards ingredients in the very low calorie diet products
  • •Severe heart, liver or kidney disease
  • •Conception by in vitro fertilization (intrauterine insemination allowed)
  • •≥4 consecutive spontaneous pregnancy loss (female)
  • •Having tried to conceive or prior time to pregnancy of more than 12 months
  • •Any medical condition or concomitant medication as judged by the medical responsible
  • •Adherence to vegan diets or other diets interfering with the dietary guidelines in the study
  • •Participation in other clinical trial

Outcomes

Primary Outcomes

Neonatal fat mass

Time Frame: Assessed at birth (strived <24 hours, but allow <48 hours)

Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD)

Secondary Outcomes

  • Adult BMI(Collected baseline, visit (V)1-19, registration of pregnancy, in gestational age (GA)8, GA13, GA20, GA28, GA36, GA39, when giving birth and at 3, 6, 12 and 18 months after birth.)
  • Obstetric - medication use(Collected from initiation of labor until completed birth of offspring.)
  • Obstetric - Neonatal unit admissions(Collected at birth and until 6 months after birth of offspring.)
  • Fetal and offspring growth - body weight(Collected in gestational age (GA)11-13, GA19-21 and GA28, at birth and 3, 6, 12 and 18 months after birth.)
  • Fetal and offspring growth - length(Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6, 12 and 18 months after birth.)
  • Fetal growth - fractional limb volume(Collected in gestational age 28.)
  • Obstetrics outcome - length of gestational age(Assessed at birth of offspring.)
  • Obstetric - obstetrics complications(Collected at birth of offspring)
  • Fetal and offspring growth - abdominal circumference(Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6, 12 and 18 months after birth.)
  • Fetal and offspring growth - crown circumference(Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6, 12 and 18 months after birth.)
  • Obstetric - pregnancy complications(Collected at registration of pregnancy, in gestational age (GA) 8, GA13, GA20, GA28, GA36 and GA39).)
  • Offspring growth - weight for gestational age(Collected at birth and 3, 6, 12 and 18 months after birth of offspring.)
  • Offspring growth - large for gestational age(Collected at birth and 3, 6, 12 and 18 months after birth of offspring.)
  • Offspring growth - apgar score(Collected at birth of offspring)
  • Offspring growth - self-reported height(18 months after birth the study staff will make an annual follow-up phone call to the parents to collect information about the offspring's self-reported body weight until the offspring is 14 of age.)
  • Obstetric - delivery mode(Collected at birth of offspring.)
  • Obstetrics - birth defects/abnormalities(Collected at birth of offspring)
  • Neonatal morbidities(Collected at birth of offspring)
  • Fetal and offspring growth - femur length(Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6, 12 and 18 months after birth.)
  • Offspring growth - body composition by the POD system(Collected at birth (strived <24 hours, but allow <48 hours), 3, 6, 12 and 18 months after birth of offspring.)
  • Offspring growth - bone markers by DEXA scan(Collected at 6, 12 and 18 months after birth of offspring.)
  • Offspring growth - small for gestational age(Collected at birth and 3, 6, 12 and 18 months after birth of offspring.)
  • Offspring heart rate(Collected 6, 12 and 18-months after birth of offspring)
  • Adult weight(The intervention: each visit(V) throughout the study (baseline to 18mo. after birth). The control: before pregnancy (baseline, V11 and V14), all visits during pregnancy, at birth, at V27≤6days after birth and 3,6,12 and 18mo. after birth)
  • Adult self-reported body weight (control group)(From baseline to registration of pregnancy (4, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 52 weeks after baseline))
  • Adult blood pressure(Collected at baseline (visit (V)0) and in gestational age (GA)36. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult resting metabolic rate(Collected at baseline visit (V)0. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult resting respiratory quotient(Collected at baseline visit (V)0. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult reproduction - Success rate(Registration of pregnancy)
  • Reproduction (male) - Sperm DNA fragmentation(Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult glucose metabolism (CGM, only female)(Collected at gestational age (GA)28+GA29)
  • Adult lipid profile(Collected at baseline (visit(V)0) and during pregnancy in gestational age (GA)36 (only female). Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Offspring growth - BMI z-score(Collected at birth and 3, 6, 12 and 18 months after birth of offspring.)
  • Offspring growth(Collected at birth and 3, 6, 12 and 18 months after birth of offspring.)
  • Offspring growth - body composition by DEXA scan(Collected at 6, 12 and 18 months after birth of offspring.)
  • Offspring blood pressure(Collected 6, 12 and 18-months after birth of offspring)
  • Offspring growth - self-reported body weight(18 months after birth the study staff will make an annual follow-up phone call to the parents to collect information about the offspring's self-reported body weight until the offspring is 14 of age.)
  • Adult anthropometric(Collected prior to pregnancy (at baseline, visit(V)5, V6, V7, V8, V12, and V16 (V5-V16 only the intervention)), during pregnancy (at registration of pregnancy, in gestational age(GA)13 and GA36), and at 3, 6, 12, and 18 months after birth of offspring.)
  • Adult reproduction - Time to pregnancy(Registration of pregnancy)
  • Offspring lipid profile(Collected at 6, 12 and 18 months after birth)
  • Offspring inflammation markers(Collected at 6, 12 and 18 months after birth)
  • Offspring growth factors and hormones(Collected at 6, 12 and 18 months after birth)
  • Adult Height(Collected at baseline (V0).)
  • Reproduction (male) - Sperm acrosomal status(Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult glucose metabolism(Collected at baseline (visit(V)0) and during pregnancy in gestational age (GA)36 (only female). Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult body composition by DEXA scan(Collected at baseline (visit (V)0), at registration of pregnancy (only male) and after birth (≤6 days after birth of offspring). Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult bone markers by DEXA scan(Collected at baseline (visit (V)0), at registration of pregnancy (only male) and after birth (≤6 days after birth of offspring). Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Offspring medication use(Birth, after 3, 6, 12, and 18 months after birth of offspring.)
  • Reproduction (male) - Sperm motility(Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Reproduction (male) - Sperm concentration(Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Reproduction (male) - Sperm morphology(Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult heart rate(Collected at baseline (visit (V)0) and in gestational age (GA)36. Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Adult medication use(Use of medication will be collected at all visits.)
  • Adult glucose metabolism (OGTT, only female)(Collected at gestational age (GA)20 and 28 or only 28 (only female))
  • Adult inflammation markers(Collected at baseline (visit(V)0) and during pregnancy in gestational age (GA)36 (only female). Additionally, at V8 (prior to pregnancy) for the intervention group.)
  • Offspring glucose metabolism(Collected at 6, 12 and 18 months after birth)

Investigators

Sponsor
Christian Mølgaard
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Christian Mølgaard

Professor

University of Copenhagen

Study Sites (1)

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