Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment

NCT ID: NCT04721938

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-04-27

Brief Summary

The detrimental effect of overweight and obesity on fecundity has been well documented.

The investigators wish to investigate the intervention program for weight loss before fertility treatment.

Subsequently to gain knowledge on the effect of overweight/obesity and weight loss on the vaginal microbiome, on DNA damage on sperm cells, on the occurrence of endocrine disruptors in the endometrium, and on the gene expression in the endometrium.

Detailed Description

Purpose and aim of the study The Fertility Clinic at Zealand University Hospital wishes to introduce a new care concept: 'Healthy Parents - Healthy Children´ with the purpose of changing the behaviours of infertile men and women towards a healthier life style now and for future generations.

The Zealand Region includes areas of significant deprivation compared to Copenhagen and has a higher prevalence of obesity and poor diet.

These inequalities generate socio-demographic and long-term health challenges, decrease the chance of becoming pregnant and increase risk of life style related diseases for parents and their offspring in the long term.

The waiting time before fertility treatment (12 months in the region) represents a unique window of opportunity to encourage long-term life style changes. The aforementioned reasons initiated the planned Preconception Clinic 'Healthy Parents - Healthy Children´.

The Preconception Clinic utilises waiting list time to optimise parental health prior to conception. We will provide weight loss interventions aimed at helping the patients to a healthier lifestyle, an increased chance of conception and a decreased risk of life style diseases for themselves and their future offspring.

Purpose of study:

Patient weight loss of at least 10% at the end of intervention and at annular follow up until 5 years.

Study population: Sub-fertile population referred to the Fertility Clinic Region Zealand due to infertility.

Inclusion criteria:

20 women and 20 men with a BMI>30, age 18-40 years.

Exclusion criteria:

Inability to understand the written and oral information.

Baseline and end of intervention-sampling:

1. Blood tests (metabolic markers), blood tests for Biobank and for miRNA biomarkers

2. Urine sample

3. Women: Endometrial biopsy and vaginal swab for microbiome testing

4. Men: Sperm sample

Intervention: Weight reduction through life style changes in diet and exercise by the following means:

• Counselling with a Nutritionist Nurse on diet and exercise.
• Online smartphone coaching program (LifeSum-App)
• Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month.

Primary endpoint: Weight loss of at least 10%.

Anticipated impact The aim of this study is to find a feasible intervention that can change adverse life styles in a preconception setting. Elements from the weight loss intervention can be incorporated to the broader community, for instance as Preconception weight loss packages in the local municipalities, aimed at optimizing health before conception in the general fertile population.

Conditions

Infertility; Overweight and Obesity; Weight Loss; Vaginal Flora Imbalance; DNA Damage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Systematic weight loss intervention

Group Type: OTHER

Systematic weight loss intervention

Intervention Type: BEHAVIORAL

Weight reduction through life style changes in diet and exercise by the following means:

• Counselling with a Nutritionist Nurse on diet and exercise
• Online Smartphone coaching program (Life-sum App)
• Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month

Interventions

Systematic weight loss intervention

Weight reduction through life style changes in diet and exercise by the following means:

• Counselling with a Nutritionist Nurse on diet and exercise
• Online Smartphone coaching program (Life-sum App)
• Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI>30
• Referred to The Fertility Clinic, Zealand Region

Exclusion Criteria

• Unable to speak and read Danish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Lis Mikkelsen, MD, PhD

Role: STUDY_DIRECTOR

The Fertility Clinic, Zealand University Hospital

Locations

The Fertility Clinic, Zealand University Hospital

Køge, , Denmark

Countries

Denmark

Other Identifiers

REG-048-2019

Identifier Type: -

Identifier Source: org_study_id