TOP-mums, for a Healthy Start

Maastricht University Medical Centre (MUMC)

Status: Terminated

Conditions: Pregnancy Complications; Overweight; Obesity

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02703753

METC152026

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle intervention

Control group

No Intervention group

Description:

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.