PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen

NCT05621109 | Recruiting

• 1 other identifier: L101
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Weight Loss; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Neonatal fat mass

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

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

Secondary Outcomes (56)

• Obstetrics outcome - length of gestational age

  Assessed at birth of offspring.

• Obstetric - medication use

  Collected from initiation of labor until completed birth of offspring.

• Obstetric - delivery mode

  Collected at birth of offspring.

• Obstetric - pregnancy complications

  Collected at registration of pregnancy, in gestational age (GA) 8, GA13, GA20, GA28, GA36 and GA39).

• Obstetric - Neonatal unit admissions

  Collected at birth and until 6 months after birth of offspring.

Other Outcomes (46)

• Cord blood - epigenetics

  Collected at birth

• Cord blood - pH

  Collected at birth

• Cord tissue

  Collected at birth

Study Arms (2)

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).

Behavioral: Weight loss intervention

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).

Interventions

Weight loss intervention BEHAVIORAL

Subjects will receive very low-calorie diet for 8-10 weeks to introduce a rapid weight loss of approximately 10%. Once target weight is achieved, participants will be reintroduced to foods to introduce weight stability. The male will follow the maternal randomization, i.e. weight loss if BMI ≥25 until a BMI of 23 or a weight loss of approximately 10% is obtained. During weight loss maintenance, subjects will receive dietary counseling to follow a diet high in protein (corresponding to 22-25E%), high fiber and wholegrain while fulfilling the requirements for essential fatty acids, micronutrients and trace elements in accordance with Nordic Nutrition Recommendations (NNR) 2012. Throughout the study period participants will be encouraged to follow the official recommendations for physical activity as recommended by the Danish health authorities 2022.

Intervention

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Maternal pre-pregnancy BMI 27.0-44.9 kg/m\^2
• Maternal age range 18-38 years
• Connected to Hvidovre Hospital as place of birth or willing to change from other Hospitals in Region H to Hvidovre Hospital
• Not pregnant or breastfeeding
• Paternal pre-pregnancy BMI 18.5-44.9 kg/m\^2
• Paternal age range 18-55 years
• Biological father
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Christian Mølgaard: lead
• Hvidovre University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Center for Healthy Childhood, Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

University of Copenhagen

Frederiksberg, DK, 1958, Denmark

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Christian Mølgaard, MD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faidon Magkos, PhD

CONTACT

+4535333671; fma@nexs.ku.dk

Malene Nygaard, MSC

CONTACT

+45 35 32 02 66; nygaard@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 17, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

DK (1)