Actively Recruiting
PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus
Led by Ulla Kampmann Opstrup · Updated on 2024-01-18
140
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
Sponsors
U
Ulla Kampmann Opstrup
Lead Sponsor
P
Per Ovesen, Professor Dept. of Obsteterics, Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is a single site parallel randomized controlled study. The study will be assessing the effect of a 10% pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant and overweight or obese (BMI 27-44.9 kg/m\^2). The couples in intervention group will receive dietitian counseling and participate in physical activity sessions to attain the 10% weight loss. 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.
CONDITIONS
Official Title
PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal pre-pregnancy BMI between 27.0 and 44.9 kg/m²
- Maternal age between 18 and 38 years
- Connected to Aarhus University Hospital as place of birth
- Currently pregnant
- Paternal pre-pregnancy BMI between 18.5 and 44.9 kg/m²
- Paternal age between 18 and 55 years
- Couples (male and female) planning pregnancy within 3 years
- Provided voluntary informed consent
- Danish or English speaking
- Intention to allow planned offspring to participate in follow-up study
- Able to store biological samples from offspring at home freezer in provided box
You will not qualify if you...
- Diabetes mellitus (type 1 or 2)
- Previous or present eating disorder
- Allergy to ingredients in very low calorie diet products
- Severe heart, liver, or kidney disease
- Conception by in vitro fertilization
- Any medical condition or medication judged by medical responsible to interfere
- Following vegan or other diets conflicting with study guidelines
- Participation in other clinical trials that might affect results
- Engaged in elite sports or strenuous exercise 5 or more hours per week at inclusion
- Blood donation or transfusion within the month before screening or during study
- Inability or unwillingness to follow study protocol or instructions
- Significant psychiatric disorders (schizophrenia, bipolar, depression) as assessed
- Polycystic ovary syndrome with irregular cycles
- Use of medications affecting body weight or pregnancy within past 3 months
- Severe food allergies or intolerances interfering with study
- Alcohol or drug abuse within past 12 months as judged by investigator
- Psychological or behavioral problems affecting compliance
- Inability to consume interventional product due to physiological or religious reasons
- Illiteracy or inadequate understanding of Danish or English
- Any other condition judged to interfere with study adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
U
Ulla K Opstrup, MD, PhD
CONTACT
L
Louise Rasmussen, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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