PRE-Pregnancy Weight Loss and the Reducing Effect on CHILDhood Overweight - Copenhagen (PREPARE CHILD)

Christian Mølgaard

Status: Enrolling

Conditions: Weight Loss; Pregnancy Related; Overweight and Obesity

Treatments: Behavioral: Weight loss intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05621109

L101

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Maternal 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 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

Parental 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)

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 2 patient groups

Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Weight loss intervention

Standard of care

No Intervention group

Description:

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).