Weight loss before pregnancy to reduce childhood obesity risk

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

This study is testing if losing 10% of their weight before getting pregnant can help healthy couples with an overweight mother reduce the risk of their child becoming overweight later on.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 38 Years
• Sex: All
• Sponsor: University of Aarhus (other)
• Locations: 1 site (Aarhus)
• Trial ID: NCT05798494 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of a 10% pre-conceptional weight loss intervention on healthy couples where the prospective mother is overweight or obese. Participants will receive dietary counseling and engage in physical activity sessions to achieve weight loss before planning a second pregnancy. The study aims to determine if this intervention can effectively lower the risk of childhood overweight and related complications in their offspring compared to a control group. A total of 140 couples will be randomized to either the intervention or control group, with a focus on maintaining a healthy lifestyle throughout the study period.

Who should consider this trial

Good fit: Ideal candidates include healthy couples with the prospective mother having a pre-pregnancy BMI of 27-44.9 kg/m² and planning a subsequent pregnancy within three years.

Not a fit: Patients with diabetes, severe medical conditions, or those who have undergone in vitro fertilization may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of childhood obesity and its associated health complications.

How similar studies have performed: Previous studies have shown promising results with weight loss interventions in similar populations, indicating potential for success in this approach.

Eligibility criteria

Maternal inclusion Criteria:

* Maternal pre-pregnancy BMI 27.0-44.9 kg/m\^2
* Maternal age range 18-38 years
* Connected to Aarhus University Hospital as place of birth
* Pregnant

Paternal Inclusion Criteria:

* Paternal pre-pregnancy BMI 18.5-44.9 kg/m\^2
* Paternal age range 18-55 years

Parental Inclusion Criteria:

* Couples (male and female)
* Planning pregnancy within 3 years
* 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
* 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 that can affect the results of the current study
* Engagement in elite sports or similar strenuous exercise ≥5 h/week at inclusion
* Blood donation or transfusion within the past month before screening
* Blood donation during the study
* Inability or unwillingness to follow the study protocol and instructions given by the study personnel

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

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:

* 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 screening
* 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

Where this trial is running

Aarhus

• Aarhus University Hospital — Aarhus, Denmark (RECRUITING)

Study contacts

• Principal investigator: Ulla K Opstrup, Assoc — Aarhus University Hospital
• Study coordinator: Ulla K Opstrup, MD, PhD

Conditions: Overweight and Obesity, Weight Loss, Pregnancy Related, Child Nutrition Sciences, Body Composition, Overweight, Pregnancy, Weight loss