Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study (TOP12)

Steno Diabetes Centers

Status: Completed

Conditions: Physical Activity; Lifestyle, Healthy; Follow-up; Obesity; Gestational Weight Gain; Diet, Healthy; Body Composition

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05446220

TOP12

Details and patient eligibility

About

The participant (both mother and child) in the initial TOP study will be invited to a follow-up study to evaluate the effect of life style intervention during pregnancy on both mother and their offspring 12 years after the intervention. The study will contribute to understanding the transfer of obesity between generations and how to treat as well as prevent obesity.

Full description

The initial study (Treatment of Obese Pregnant women (TOP) study) was performed at Hvidovre Hospital, University of Copenhagen in 2009-12 and included 425 pregnant women with pre-gestational BMI ≥ 30kg/m2 in gestational week 11-14. They were randomized 1:1:1 into: 1) a low-calorie Mediterranean-style diet and pedometer assisted physical activity (PA) intervention 2) a pedometer assisted PA intervention alone or 3) no intervention (control). Primary outcome was gestational weight gain (GWG). 389 women completed the study.

The participants (both mother and child in pair) who completed the initial TOP study will be invited to a 3-hour examination now 12 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.

Enrollment: 497 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants/mothers in the initial TOP study will be invited with their offspring born following the pregnancy during the initial study to the 12-year follow-up study

Exclusion criteria

• There are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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497 participants in 3 patient groups

Diet + physical activity

Experimental group

Description:

Dietary advise and advise on physical activity monitored by pedometer

Treatment:

Behavioral: Lifestyle intervention

Physical activity

Experimental group

Description:

Advise on physical activity monitored by pedometer

Treatment:

Behavioral: Lifestyle intervention

Control

No Intervention group

Description:

No intervention