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Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

13. oktober 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

281

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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
Adfærdsmæssigt: Lifestyle Intervention Group
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gestational Weight Gain (GWG)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Gestational Diabetes
Tidsramme: 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
Tidsramme: 14-37 wks
Blood will be collected at Baseline and 35-37 weeks.
14-37 wks
High-density Lipoprotein (HDL)
Tidsramme: 14-37 wks
Blood will be collected at Baseline and 35-37 weeks.
14-37 wks
Low-density Lipoprotein (LDL)
Tidsramme: 14-37 weeks
Blood will be collected at Baseline and 35-37 weeks.
14-37 weeks
Total Cholesterol
Tidsramme: 14-37 Weeks
Blood will be collected at Baseline and 35-37 weeks.
14-37 Weeks
Triglycerides
Tidsramme: 14-37 Weeks
Blood will be collected at Baseline and 35-37 weeks.
14-37 Weeks
Leptin
Tidsramme: 14-37 weeks
Blood will be collected at Baseline and 35-37 weeks.
14-37 weeks
Steady State Beta Cell Function
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Delivery
Neonatal Body measurements
Delivery
Birth Length
Tidsramme: Delivery
Neonate birth measures
Delivery
Head Circumference
Tidsramme: Delivery
Neonate birth measures
Delivery
Neonate Percent Body Fat
Tidsramme: Delivery
Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
Delivery
Infant Weight
Tidsramme: 1 year
Infant Body measurements
1 year
Infant Length
Tidsramme: 1 year
Infant body measurement
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northwestern University

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Efterforskere

  • Ledende efterforsker: Linda V Van Horn, PhD, Northwestern University
  • Ledende efterforsker: Alan Peaceman, MD, Northwestern Memorial Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2012

Primær færdiggørelse (Faktiske)

31. juli 2017

Studieafslutning (Faktiske)

31. juli 2017

Datoer for studieregistrering

Først indsendt

25. juni 2012

Først indsendt, der opfyldte QC-kriterier

27. juni 2012

Først opslået (Skøn)

29. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DK10-014
  • 1U01HL114344-01 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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