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Идёт набор NCT07467694

Postnatal Exercise to Activate Baby's Brown Fat

Без фазы С лечением Childhood Obesity Prevention Childhood Obesity Physical Activity Lactation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Active group.
Кому может быть актуально
Состояния в реестре: Childhood Obesity Prevention, Childhood Obesity, Physical Activity, Lactation. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Impact of Acute Exercise and Habitual Physical Activity on Human Milk Composition and Childhood Obesity Risk

Обзор

The purpose of this study is to learn how exercise and physical activity during pregnancy and after pregnancy may affect the composition of breastmilk. Certain changes in breast milk after exercise may have an impact on how infants use energy. Understanding this process may improve public health recommendations for exercise during and after pregnancy. This study can help investigators learn more about how maternal exercise patterns may affect body growth and obesity risk in infants who are breastfed. This research may help identify how different factors can influence healthy weight and early development in infants.

Подробное описание

Epidemiological studies suggest that breastfeeding protects against risk of obesity, diabetes, asthma, and other childhood diseases. However, the specific compounds within breastmilk that are responsible for its protective effects are not fully understood. Moreover, prior work from this investigative team has shown that human milk composition varies substantially between individuals according to factors such as body mass index (BMI), diabetes status, diet, and physical activity. Gaining a better understanding of how modifiable risk factors may impact human milk composition would have the potential to identify strategies to enhance the health-promoting benefits of human milk.

In this project, the investigators will study the impact of maternal exercise on human milk composition. The central hypothesis is that maternal exercise induces changes in breast milk metabolites and lipids that result in activation of infant brown fat, increased infant energy expenditure, and reduced obesity risk.

The study will include assessments of habitual activity during pregnancy and the postpartum period, supervised bouts acute moderate exercise, as well as analysis of human milk composition, infant growth and body composition, and infant energy expenditure.

Вмешательства

  • Поведенческое Active group
    For participants randomized to the Active group, there will be weekly phone calls with study staff during which step counts and exercise bouts from the previous week will be reviewed, and exercise goals for the following week will be gradually increased.

Первичные конечные точки

  • Altered breast milk lipidome [Срок оценки: 8 weeks]
  • Altered breast milk metabolome [Срок оценки: 8 weeks]
Вторичные конечные точки (3)
  • Infant body composition [Срок оценки: 3 months, 6 months, and 12 months]
  • Infant body mass index (BMI) [Срок оценки: 3 months, 6 months, and 12 months]
  • Infant resting metabolic rate [Срок оценки: 3 months of age]

Критерии участия

Критерии включения

  • 18-45 y of age at the time of enrollment
  • Pre-gravid or first trimester BMI 18.5 -40 kg/m2
  • Uncomplicated singleton pregnancy
  • Intention to exclusively breastfeed for >3 months and, if parity >1, that they successfully breastfed a previous pregnancy
  • Term pregnancy (gestational age 37 to <42 weeks)
  • Infant with birth weight >10th percentile of weight for gestational age

Критерии исключения

  • Any obstetric contra-indication to exercise at 1 month
  • Diagnosis of uncontrolled (HbA1c >7%) type 1 or type 2 diabetes, or gestational diabetes managed with insulin
  • Intrauterine growth restriction
  • Pre-eclampsia or other pregnancy complications
  • Alcohol, cannabis or tobacco use
  • Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding/growth
  • Major fetal anomalies
  • Musculoskeletal issues that would make exercise difficult

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
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 2 центра
  • Joslin Diabetes Center — Boston
  • Oklahoma University College of Medicine — Oklahoma City

Идентификаторы

NCT: NCT07467694 · STUDY00000313 · R01HD117197

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗