LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

Официальное название

LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers): Identification of Modifiable Risk Factors for Childhood Obesity - a Follow-up of a Randomized Controlled Trial

Обзор

The study is a follow-up of a Randomized Controlled Trial (RCT) performed in 2007-10 - the "Lifestyle in Pregnancy" LiP study. The LiP study included 360 pregnant women with BMI ≥30 kg/m2 from Odense University Hospital and Aarhus University Hospital. The women were randomized to intervention with low-calorie diet and physical activity from gestational age 10-14 in pregnancy and until delivery - or to a standard care control group. The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring. The overall ambition is to understand whether lifestyle intervention in pregnancy prevents obesity and its complications across generations, with a specific focus on modifiable factors.

Подробное описание

LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers): Identification of modifiable risk factors for childhood obesity - a follow-up of a randomized controlled trial.

The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring.

In the original trial women were randomized 1:1 to intervention or control. The participants (both mother and child in pair) who completed the initial LiP study will be invited to a 2-hour examination now 14 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.

Вмешательства

• Поведенческое Lifestyle intervention Dietary advise and/or advise on physical activity
  Lifestyle intervention Dietary advise and/or advise on physical activity

Первичные конечные точки

• Fat mass index , measured by DEXA scan. [Срок оценки: 2 years data collection]

Вторичные конечные точки (12)

• Glycemic variability [Срок оценки: 2 years data collection]
• Mental health [Срок оценки: 2 years data collection]
• Diet composition [Срок оценки: 2 years data collection]
• Physical activity (PA) [Срок оценки: 2 years data collection]
• Puberty stage [Срок оценки: 2 years data collection]
• Blood pressure [Срок оценки: 2 years data collection]
• Epigenetic examinations [Срок оценки: 2 years data collection]
• Metabolic and inflammatory markers [Срок оценки: 2 years data collection]
• HbA1c [Срок оценки: 2 years data collection]
• Metabolic markers [Срок оценки: 2 years data collection]
• Electrolytes [Срок оценки: 2 years data collection]
• Insulin [Срок оценки: 2 years data collection]

Критерии участия

Критерии включения

• Mothers in the initial LiP study selected at the baseline study in 2007-2010
• Teenagers of mothers in the initial LiP study

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

• Steno Diabetes Center Odense — Odense

Публикации

• Luef BM, Jensen NH, Knorr S, Kristensen K, Overgaard M, Stentebjerg LL, Catalano PM, Moller S, Maindal HT, Jensen DM, Vinter CA. Study protocol for a 15-year follow-up of a randomized controlled trial on lifestyle intervention in pregnancy: assessing long-term effects on body composition, metabolic traits, and mental health in mothers and offspring. Trials. 2026 Jan 14;27(1):124. doi: 10.1186/s130 PMID 41535891

Идентификаторы

NCT: NCT05774652 · LiPO-Teen

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗