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TOP-mums, for a Healthy Start

NCT02703753 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-05-10

No results posted yet for this study

Summary

This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.

Conditions

Interventions

BEHAVIORAL

Lifestyle intervention

The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Anita Vreugdenhil, MD, PhD · Maastricht UMC+

  • Luc Zimmermann, Prof, MD · Maastricht UMC+

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-27
Primary Completion
2023-12-31
Completion
2024-04-22

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02703753 on ClinicalTrials.gov