NCT05621109进行中（未招募）不适用
PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - a Randomized Controlled Study in Copenhagen
Christian Mølgaard1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年12月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Neonatal fat mass
研究概览
简要总结
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 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maternal inclusion Criteria:
- •Maternal pre-pregnancy BMI 27.0-44.9 kg/m^2
- •Maternal age range 18-38 years
- •Not pregnant or breastfeeding
- •Paternal Inclusion Criteria - full protocol (optional participation):
- •Paternal pre-pregnancy BMI 18.5-44.9 kg/m^2
- •Paternal age range 18-55 years
- •Biological father
- •Parental 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
排除标准
- •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
- •Engagement in elite sports or similar strenuous exercise ≥5 h/week
- •Blood donation or transfusion within the past month before baseline
- •Blood donation during the study
- •Inability or unwillingness to follow the study protocol and instructions given by the study personnel
- •Pregnancy registered between baseline visit and 4 weeks after the baseline visit (urinary analysis with dipstick)
- •A detailed description of the exclusion criteria is given below:
- •Medical conditions as known by the participant:
- •Diabetes mellitus (type 1 and 2)
- •History or diagnosis of eating disorder (e.g. restrained eating, disinhibition, emotional eating)
- •Any significant medical condition as assessed by the investigator (e.g. dysregulated thyroid disease or reproductive diseases)
- •Any significant psychiatric disorder (i.e. schizophrenia, bipolar disease or depression) as assessed by the investigator
- •Severe chronic heart, liver and kidney disease
- •Polycystic ovary syndrome with irregular cycle
- •Amenorrhea
- •Severely reduced semen quality incl. azoospermia
- •Medication:
- •- Current use of medication or use within the previous three months with a potential to affect body weight or pregnancy as judged by the investigator (e.g. systemic corticoids)
- •Personal/other:
- •Having tried to conceive or prior time to pregnancy of more than 12 months
- •Weight changes ± 5% three months prior to inclusion
- •Severe food allergies, food intolerances or dislike expected to interfere with the study, including allergy towards ingredients in the VLCD products
- •Engagement in elite sports or similar strenuous exercise ≥5 h/week
- •Blood donation or transfusion within the past month before baseline
- •Planned blood donation for other purpose than this study during participation
- •Alcohol abuse, as judged by the investigator, within the previous 12 months
- •Drug abuse, as judged by the investigator, within the previous 12 months
- •Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the study protocol
- •Participation in other clinical trials within the past three months or intention to do so during the study, which are judged by the investigator to affect the present study
- •Unable to consume the interventional product for religious reasons, swallowing disorders, other physiological reasons or any other reasons for not being able to follow the recommended diet
- •Inability or unwillingness to give written informed consent or communicate with study personnel
- •Inability or unwillingness to follow the study protocol and instructions given by the study personnel
- •Illiteracy or inadequate understanding of Danish or English language.
- •Any other condition that judged by the investigator may interfere with the adherence to the study protocol
研究组 & 干预措施
Intervention
Experimental
Rapid moderate weight loss (approximately 10% of body weight at baseline over 8-10 weeks or BMI 23 kg/m^2 is achieved) by very low-calorie diet (VLCD), reintroduction (4 weeks), weight loss maintenance until pregnancy (up to 12 months), and a high protein, high fiber diet during pregnancy (n=120 females/couples).
干预措施: Weight loss intervention (Behavioral)
Standard of care
No Intervention
The control group will not receive any dietary advice prior to pregnancy. During pregnancy control subjects will receive dietary advice similar to the intervention group, i.e. a high protein, high fiber diet (n=120 females/couples).
结局指标
主要结局
Neonatal fat mass
时间窗: Assessed at birth (strived <24 hours, but allow <48 hours)
Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD)
次要结局
- Adult reproduction - Time to pregnancy(Registration of pregnancy)
- Reproduction (male) - Sperm acrosomal status(Collected baseline and at visit (V) 11. 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.)
- 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 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)
- Obstetric - pregnancy complications(Collected at registration of pregnancy, in gestational age (GA) 8, GA13, GA20, GA28, GA36 and GA39).)
- Offspring growth - apgar score(Collected at birth of offspring)
- Obstetric - delivery mode(Collected at birth of offspring.)
- Obstetrics - birth defects/abnormalities(Collected at birth of offspring)
- Neonatal morbidities(Collected at birth of offspring)
- 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.)
- Adult Height(Collected at baseline (V0).)
- 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 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.)
- 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.)
- Fetal and offspring growth - body weight(Collected in gestational age (GA)11-13, GA19-21 and GA28, at birth and 3, 6 and 12 months after birth.)
- Fetal and offspring growth - length(Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6 and 12 months after birth.)
- Fetal and offspring growth - abdominal circumference(Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6 and 12 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 and 12 months after birth.)
- Fetal and offspring growth - femur length(Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6 and 12 months after birth.)
- Offspring growth - BMI z-score(Collected at birth and 3, 6 and 12 months after birth of offspring.)
- Offspring growth - weight for gestational age(Collected at birth and 3, 6 and 12 months after birth of offspring.)
- Offspring growth - large for gestational age(Collected at birth and 3, 6 and 12 months after birth of offspring.)
- Offspring growth - small for gestational age(Collected at birth and 3, 6 and 12 months after birth of offspring.)
- Offspring growth(Collected at birth and 3, 6 and 12 months after birth of offspring.)
- Offspring growth - body composition by the POD system(Collected at birth (strived <24 hours, but allow <48 hours) and 3 months after birth of offspring.)
- Offspring blood pressure(Collected 12 months after birth of offspring)
- Offspring heart rate(Collected 12 months after birth of offspring)
- Offspring growth - self-reported body weight(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.)
- Offspring growth - self-reported height(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 weight(The intervention: each visit(V) throughout the study (baseline to 12mo. after birth). The control: before pregnancy (baseline, V11 and V14), all visits during pregnancy, at birth, at V27≤6days after birth and 3, 6 and 12 mo. after birth)
- 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 and 12 months after birth.)
- 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 and 12 months after birth of offspring.)
- Offspring medication use(Birth, after 3, 6 and 12 months after birth of offspring.)
- Offspring glucose metabolism(Collected at 12 months after birth)
- Offspring lipid profile(Collected at 12 months after birth)
- Offspring inflammation markers(Collected at 12 months after birth)
- Offspring growth factors and hormones(Collected at 12 months after birth)
研究者
Christian Mølgaard
Professor
University of Copenhagen
研究点 (1)
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