TOP-mums, for a Healthy Start

NCT02703753 | Terminated

• 1 other identifier: METC152026
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Overweight; Obesity; Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Reduction in body weight

  From baseline to 6 weeks postpartum

Secondary Outcomes (42)

• Gestational weight gain

  6 weeks of gestational age to 36 weeks of gestational age

• Postpartum weight retention

  6 weeks of gestational age to 6 months postpartum

• Smoking cessation

  Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.

• Biochemical verification of tobacco use

  Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.

• Dietary habits

  Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention is an integral and multidisciplinary lifestyle intervention consisting of a healthy diet, appropriate physical activity and, if applicable, smoking cessation, customised to the needs of the women.

Behavioral: Lifestyle intervention

Control group

NO INTERVENTION

The control group will receive usual care, including standard lifestyle advices during consultation with the GP, midwife, obstetrician or at the child well being centre. Furthermore, the control group will receive 1 recipe for a healthy meal per week.

Interventions

Lifestyle intervention BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a pregnancy wish within 1 year;
• Aged 18-40 years;
• Overweight/obesity (BMI ≥ 25 kg/m2).

You may not qualify if:

• Haemodynamically significant heart disease;
• Restrictive lung disease;
• Congenital metabolic disease;
• Mentally retarded;
• Bariatric surgery;
• Diabetes type II, dependent on medicine.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (1)

• Timmermans YEG, van de Kant KDG, Reijnders D, Kleijkers LMP, Dompeling E, Kramer BW, Zimmermann LJI, Steegers-Theunissen RPM, Spaanderman MEA, Vreugdenhil ACE. Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands. BMJ Open. 2019 Nov 19;9(11):e030236. doi: 10.1136/bmjopen-2019-030236.

  PMID: 31748290 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Pregnancy Complications

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anita Vreugdenhil, MD, PhD

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

• Luc Zimmermann, Prof, MD

  Maastricht UMC+

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 9, 2016
• Study Start: July 27, 2016
• Primary Completion: December 1, 2023
• Study Completion: April 22, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

NL (1)