Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05798494

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

Sponsor: Ulla Kampmann Opstrup

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 38 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2023-06-01

Completion Date

2028-04-11

Last Updated

2024-01-18

Healthy Volunteers

Yes

Conditions

Overweight and Obesity Weight Loss Pregnancy Related Child Nutrition Sciences Body Composition

Interventions

BEHAVIORAL

Weight loss intervention

Subjects will receive dietary counseling by a dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The mother (and father if overweight, BMI ≥25 kg/m\^2) will receive advice to provide a moderate caloric restriction (-500 to 1000 kcal/d) and power walk 2-4 times a week for a half an hour and attend physical activity sessions every 2nd week to attain a minimum weight loss of approximately 0,5-1,0 kg/week. The weight loss will last until a 10% weight loss (according to pre-pregnancy weight) has been achieved or until 1-year post-partum. If the subject has not achieved a weight loss of 10%, she or he will receive Very low-calorie diet (VLCD) until target weight loss is reached, though no longer than 8 weeks. After weight loss subjects will receive counseling to maintain weight loss and healthy weight gain during pregnancy until birth of the 2nd child.

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

Locations (1)

Aarhus University Hospital

Aarhus, Denmark