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

NCT05798494 | Recruiting

• 1 other identifier: Prepare Child AUH
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Overweight; Pregnancy; Weight loss; Diet, Reducing; Epigenetics; Healthy Lifestyle; DNA Methylation; Exercise; Offspring's neonatal fat mass; Pea Pod; Infant, Large for Gestational Age; Body Fat Distribution

Outcome Measures

Primary Outcomes (2)

• Neonatal fat mass

  Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD)

  Collected within the first week of birth (strived <48 hours)

• Difference in epigenetic changes in child 1 and 2

  Cord blood from offspring will be collected at birth and stored at -80 °C until use. At the Department of Molecular Medicine AUH genomic DNA will be extracted from peripheral blood using standard methods e.g., QIAmp® Mini Kit (Qiagen, Germany). 1 μg of genomic DNA will be bisulfide converted using Illumina iScan (platform). The methylation level will be measured using Infinium MethylationEPIC DNA Analysis BeadChip (Array type) at Eurofins Genomics AS (Denmark) or similar methods. The stated required sample size (140 couples) is calculated based on the neonatal fat mass. As no other studies have performed methylation analysis using WGBS in similar cohorts, precise power calculations on epigenetic changes are impractical. However, since the EPICOM study found differentially methylated regions in only 20 cases and 20 controls using Illumina's 450K methylation assay, the power to elucidate epigenetic changes is considered sufficient in the planned study.

  Assessed at birth

Secondary Outcomes (145)

• Obstetrics outcome - length of gestational age

  Assessed at birth of both offsprings

• Obstetric - medication use

  Collected from initiation of labor until completed birth of both offsprings

• Obstetric - delivery mode

  Collected at birth of both offsprings

• Obstetric - pregnancy complications

  Collected at gestational age (GA) 34-36 and after birth of both offsprings

• Obstetric - Neonatal unit admissions

  Collected at birth and until 12 months after birth of both offsprings

Other Outcomes (43)

• Offspring feces - Microbiome

  Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring

• Offspring feces - Short chain fatty acids

  Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring

• Offspring feces - Metabolomics

  Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group will receive dietary counseling by a trained dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The mother will receive advice to provide a moderate caloric restriction (-500 to 1000 kcal/d) and attend physical activity sessions to attain a 10 % weight loss according to pre-pregnancy weight. If the father is also overweight or obese, he will receive the same advice.

Behavioral: Weight loss intervention

Control

NO INTERVENTION

The control group will receive standard care and will not receive any dietary advice prior to pregnancy. During pregnancy control subjects will receive dietary advice according to standard care which means no counselling from a dietitian unless there are special needs (e.g., gestational diabetes), then they will receive counseling from a dietitian in accordance with standard care.

Interventions

Weight loss intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• Ulla Kampmann Opstrup: lead
• Per Ovesen, Professor Dept. of Obsteterics, Aarhus University Hospital: collaborator
• Jens Meldgaard Bruun, Professor Steno Diabetes Center Aarhus, Aarhus University Hospital: collaborator
• Sine Knorr, PhD Steno Diabetes Center Aarhus, Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Related Publications (1)

• Rasmussen L, Knorr S, Antoniussen CS, Bruun JM, Ovesen PG, Fuglsang J, Kampmann U. The Impact of Lifestyle, Diet and Physical Activity on Epigenetic Changes in the Offspring-A Systematic Review. Nutrients. 2021 Aug 17;13(8):2821. doi: 10.3390/nu13082821.

  PMID: 34444981 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Ulla K Opstrup, Assoc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulla K Opstrup, MD, PhD

CONTACT

+4522370857; ullaopst@rm.dk

Louise Rasmussen, MSc

CONTACT

+4528731648; louisesuder@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: 140 couples will be recruited and randomized to either intervention og control. Participants includes the mother, father and 1st and 2nd child, therefore the total number of participants will be 560.

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 4, 2023
• Study Start: June 1, 2023
• Primary Completion: April 11, 2025
• Study Completion (Estimated): April 11, 2028
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)