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

NCT ID: NCT05621109

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2033-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

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).

Group Type: EXPERIMENTAL

Weight loss intervention

Intervention Type: 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.

Standard of care

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Weight loss intervention

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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
• 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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dept. of Obstetrics and Gynecology, Hvidovre Hospital, Denmark

UNKNOWN

Sponsor Role: collaborator

Department of Growth and Reproduction Rigshospitalet, Denmark

UNKNOWN

Sponsor Role: collaborator

Center for Healthy Childhood, Denmark

UNKNOWN

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Christian Mølgaard

OTHER

Sponsor Role: lead

Responsible Party

Christian Mølgaard

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian Mølgaard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

University of Copenhagen

Frederiksberg, DK, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Faidon Magkos, PhD

Role: CONTACT

fma@nexs.ku.dk

+4535333671

Malene Nygaard, MSC

Role: CONTACT

nygaard@nexs.ku.dk

+45 35 32 02 66

Facility Contacts

Faidon Magkos, PhD

Role: primary

fma@nexs.ku.dk

+4535333671

Malene Nygaard, MSC

Role: backup

nygaard@nexs.ku.dk

+4535320266

Other Identifiers

L101

Identifier Type: -

Identifier Source: org_study_id