- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01631747
Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60611
- Northwestern Memorial Hospital; Prentice Women's
-
Chicago, Illinois, Förenta staterna, 60611
- Northwestern University: Dept of Preventive Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / 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.
|
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.
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Gestational Weight Gain (GWG)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants With Gestational Diabetes
Tidsram: 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
Tidsram: 14-37 wks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 wks
|
High-density Lipoprotein (HDL)
Tidsram: 14-37 wks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 wks
|
Low-density Lipoprotein (LDL)
Tidsram: 14-37 weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 weeks
|
Total Cholesterol
Tidsram: 14-37 Weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 Weeks
|
Triglycerides
Tidsram: 14-37 Weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 Weeks
|
Leptin
Tidsram: 14-37 weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 weeks
|
Steady State Beta Cell Function
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: Delivery
|
Neonatal Body measurements
|
Delivery
|
Birth Length
Tidsram: Delivery
|
Neonate birth measures
|
Delivery
|
Head Circumference
Tidsram: Delivery
|
Neonate birth measures
|
Delivery
|
Neonate Percent Body Fat
Tidsram: Delivery
|
Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
|
Delivery
|
Infant Weight
Tidsram: 1 year
|
Infant Body measurements
|
1 year
|
Infant Length
Tidsram: 1 year
|
Infant body measurement
|
1 year
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Linda V Van Horn, PhD, Northwestern University
- Huvudutredare: Alan Peaceman, MD, Northwestern Memorial Hospital
Publikationer och användbara länkar
Allmänna publikationer
- Redman LM, Drews KL, Klein S, Horn LV, Wing RR, Pi-Sunyer X, Evans M, Joshipura K, Arteaga SS, Cahill AG, Clifton RG, Couch KA, Franks PW, Gallagher D, Haire-Joshu D, Martin CK, Peaceman AM, Phelan S, Thom EA, Yanovski SZ, Knowler WC; LIFE-Moms Research Group. Attenuated early pregnancy weight gain by prenatal lifestyle interventions does not prevent gestational diabetes in the LIFE-Moms consortium. Diabetes Res Clin Pract. 2021 Jan;171:108549. doi: 10.1016/j.diabres.2020.108549. Epub 2020 Nov 22.
- Peaceman AM, Clifton RG, Phelan S, Gallagher D, Evans M, Redman LM, Knowler WC, Joshipura K, Haire-Joshu D, Yanovski SZ, Couch KA, Drews KL, Franks PW, Klein S, Martin CK, Pi-Sunyer X, Thom EA, Van Horn L, Wing RR, Cahill AG; LIFE-Moms Research Group. Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. Obesity (Silver Spring). 2018 Sep;26(9):1396-1404. doi: 10.1002/oby.22250. Epub 2018 Sep 6.
- Clifton RG, Evans M, Cahill AG, Franks PW, Gallagher D, Phelan S, Pomeroy J, Redman LM, Van Horn L; LIFE-Moms Research Group. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring). 2016 Feb;24(2):305-13. doi: 10.1002/oby.21330. Epub 2015 Dec 26.
- Van Horn L, Peaceman A, Kwasny M, Vincent E, Fought A, Josefson J, Spring B, Neff LM, Gernhofer N. Dietary Approaches to Stop Hypertension Diet and Activity to Limit Gestational Weight: Maternal Offspring Metabolics Family Intervention Trial, a Technology Enhanced Randomized Trial. Am J Prev Med. 2018 Nov;55(5):603-614. doi: 10.1016/j.amepre.2018.06.015. Epub 2018 Sep 24.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DK10-014
- 1U01HL114344-01 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Graviditet
-
King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekryteringCirros, lever | HELLP syndrom | Intrahepatisk kolestas av graviditet | Graviditetssjukdom | AFLP - Acute Fatty Lever of PregnancyStorbritannien
Kliniska prövningar på Usual Care Group
-
Community Health Center of Franklin CountyMassachusetts General Hospital; Just RootsOkänd
-
Queen's UniversityCanadian Institutes of Health Research (CIHR)Avslutad
-
Johns Hopkins UniversityJohns Hopkins Alliance for a Healthier WorldAktiv, inte rekryterande
-
National Institute of Diabetes and Digestive and...Detroit Department of HealthAvslutad
-
University of NebraskaNational Heart, Lung, and Blood Institute (NHLBI); Wayne State University; Henry Ford Health System och andra samarbetspartnersAvslutadHjärtsviktFörenta staterna
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); University of Pennsylvania; Washington University... och andra samarbetspartnersAvslutadEndometriecancerFörenta staterna
-
San Francisco Veterans Affairs Medical CenterRekrytering
-
Albert Einstein College of MedicineColumbia University; University of Rochester; Rutgers UniversityAvslutadPediatrisk fetma | Karies i tidig barndomFörenta staterna
-
University of PennsylvaniaNational Cancer Institute (NCI); American Cancer Society, Inc.AvslutadFibros | Huvud- och halscancer | LymfödemFörenta staterna
-
VA Office of Research and DevelopmentAvslutadPTSD | Posttraumatisk stressyndromFörenta staterna