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Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

13. října 2018 aktualizováno: Linda Van Horn, Northwestern University

Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

The prevalence of maternal overweight and obesity has nearly doubled in the United States since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23% in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain (GWG) through recommended diet, activity and lifestyle changes that are to be maintained postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be measured for length, weight and percent body fat. The goal is to limit excessive gestational weight gain through improved maternal lifestyle that can be maintained and modelled for the family post partum and beyond.

Přehled studie

Detailní popis

A Randomized Control Trial is planned among ethnically diverse OW/OB pregnant women ages 18-45 years to be randomly assigned to the MOMFIT Active Intervention Group (AIG) or the Educational Control Group (ECG) plus standard obstetrical care. The Dietary Approaches to Stop Hypertension (DASH) diet, along with moderate physical activity and group intervention as utilized in the Diabetes Prevention Program (DPP), will be adapted for pregnant and postpartum women through individual visits to tailor calorie/nutrient/activity goals, plus group coaching sessions and electronic self-monitoring behavior. Evidence based motivational interviewing and state of the art self-monitoring tools involving the LoseIt app will be adapted for pregnant/postpartum women via smartphone or Internet access, along with tailored feedback and encouragement from the Lifestyle Coach. Prevention of excessive GWG and achievement of the Institute Of Medicine (IOM) weight gain goals will be compared between groups, whether ongoing adherence to the lifestyle interventions can be sustained through postpartum intervention. Approximately one third of the participants are expected to be minorities and/or from low income backgrounds. The primary outcome is gestational weight gain from baseline (self-reported prepregnancy weight) to near delivery (36 weeks) compared with IOM goals in both groups and postpartum weight retention between 6 weeks and 12 months postpartum. Additional outcome variables include changes in maternal Body Mass Index (BMI) and adiposity postpartum, blood pressure, blood glucose, insulin, Hemoglobin A1c (HbA1c), C-reactive Protein (CRP), and lipids, diet quality, and physical activity levels, offspring adiposity and anthropometrics, and glucose and C-peptide in cord blood

Typ studie

Intervenční

Zápis (Aktuální)

281

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Illinois
      • Chicago, Illinois, Spojené státy, 60611
        • Northwestern Memorial Hospital; Prentice Women's
      • Chicago, Illinois, Spojené státy, 60611
        • Northwestern University: Dept of Preventive Medicine

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 45 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • Age 18-45 years
  • Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14 weeks by project gestational age. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there should be no evidence of more than one fetus on the most recent pre-randomization ultrasound.
  • Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15 weeks 6 days based on an algorithm (see Section 3.4.3 below) that compares the last menstrual period (LMP) date and data from the earliest ultrasound
  • Body mass index between 25-35 kg/m2 based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study will be used.

Exclusion Criteria:

  • In vitro fertilization (IVF) conception/ovulation induction w/ gonadotropins
  • Weight gain of >15 pounds from reported prepregnancy weight to Baseline visit
  • Current smoker
  • Prior bariatric surgery
  • In weight loss program w/in 3 months of conception
  • History of alcohol or drug abuse within 5 years
  • No access to internet and/or smartphone
  • Unable to attend intervention/follow-up visits
  • Unwilling/unable to commit to self-monitoring data collection
  • Unable to complete intervention program
  • Presence of any condition that limits walking or following diet recommendations
  • Not fluent in English

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Usual Care Group
Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.
Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.
Experimentální: Lifestyle Intervention Group
Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer
Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Gestational Weight Gain (GWG)
Časové okno: 14-37 weeks
The primary outcome is GWG as assessed continuously by the difference between the maternal weight measured at the baseline and at the 35-37 week visit.
14-37 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Gestational Diabetes
Časové okno: 24-26 weeks
Oral Glucose Tolerance Test (OGTT) will be administered at 24-26wks, as part of routine obstetric visit. Difference in incidence of Gestational diabetes between study groups will be documented.
24-26 weeks
Fasting Glucose
Časové okno: 14-37 wks
Blood will be collected at Baseline and 35-37 weeks.
14-37 wks
High-density Lipoprotein (HDL)
Časové okno: 14-37 wks
Blood will be collected at Baseline and 35-37 weeks.
14-37 wks
Low-density Lipoprotein (LDL)
Časové okno: 14-37 weeks
Blood will be collected at Baseline and 35-37 weeks.
14-37 weeks
Total Cholesterol
Časové okno: 14-37 Weeks
Blood will be collected at Baseline and 35-37 weeks.
14-37 Weeks
Triglycerides
Časové okno: 14-37 Weeks
Blood will be collected at Baseline and 35-37 weeks.
14-37 Weeks
Leptin
Časové okno: 14-37 weeks
Blood will be collected at Baseline and 35-37 weeks.
14-37 weeks
Steady State Beta Cell Function
Časové okno: baseline (14 weeks) and 35-37 weeks
Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Steady State beta cell function (%B). 100% is set at normal reference. Should not be interpreted alone, but in combination with Insulin Sensitivity (%S).
baseline (14 weeks) and 35-37 weeks
Insulin Sensitivity
Časové okno: baseline(14 weeks) and 35-37 weeks
Insulin resistance will be measured with the assistance of a computer program which will yield the Homeostatic Model Assessment (HOMA) Insulin Sensitivity (%S). 100% is equivalent to the normal reference, but needs to be interpreted in context of %B.
baseline(14 weeks) and 35-37 weeks
Insulin Resistance (IR)
Časové okno: Baseline (14 weeks) and 35 weeks

Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Insulin Resistance. HOMA IR (insulin resistance) is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (100/%S); Lower IR is better.

Note: estimates are model-derived, and not linear approximations.

Baseline (14 weeks) and 35 weeks
Birth Weight
Časové okno: Delivery
Neonatal Body measurements
Delivery
Birth Length
Časové okno: Delivery
Neonate birth measures
Delivery
Head Circumference
Časové okno: Delivery
Neonate birth measures
Delivery
Neonate Percent Body Fat
Časové okno: Delivery
Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
Delivery
Infant Weight
Časové okno: 1 year
Infant Body measurements
1 year
Infant Length
Časové okno: 1 year
Infant body measurement
1 year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Linda V Van Horn, PhD, Northwestern University
  • Vrchní vyšetřovatel: Alan Peaceman, MD, Northwestern Memorial Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2012

Primární dokončení (Aktuální)

31. července 2017

Dokončení studie (Aktuální)

31. července 2017

Termíny zápisu do studia

První předloženo

25. června 2012

První předloženo, které splnilo kritéria kontroly kvality

27. června 2012

První zveřejněno (Odhad)

29. června 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. listopadu 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. října 2018

Naposledy ověřeno

1. října 2018

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • DK10-014
  • 1U01HL114344-01 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Usual Care Group

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