- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01631747
Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Illinois
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Chicago, Illinois, Yhdysvallat, 60611
- Northwestern Memorial Hospital; Prentice Women's
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Chicago, Illinois, Yhdysvallat, 60611
- Northwestern University: Dept of Preventive Medicine
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: 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.
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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.
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Kokeellinen: 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
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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
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Gestational Weight Gain (GWG)
Aikaikkuna: 14-37 weeks
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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.
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14-37 weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Percentage of Participants With Gestational Diabetes
Aikaikkuna: 24-26 weeks
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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.
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24-26 weeks
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Fasting Glucose
Aikaikkuna: 14-37 wks
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Blood will be collected at Baseline and 35-37 weeks.
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14-37 wks
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High-density Lipoprotein (HDL)
Aikaikkuna: 14-37 wks
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Blood will be collected at Baseline and 35-37 weeks.
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14-37 wks
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Low-density Lipoprotein (LDL)
Aikaikkuna: 14-37 weeks
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Blood will be collected at Baseline and 35-37 weeks.
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14-37 weeks
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Total Cholesterol
Aikaikkuna: 14-37 Weeks
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Blood will be collected at Baseline and 35-37 weeks.
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14-37 Weeks
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Triglycerides
Aikaikkuna: 14-37 Weeks
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Blood will be collected at Baseline and 35-37 weeks.
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14-37 Weeks
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Leptin
Aikaikkuna: 14-37 weeks
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Blood will be collected at Baseline and 35-37 weeks.
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14-37 weeks
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Steady State Beta Cell Function
Aikaikkuna: baseline (14 weeks) and 35-37 weeks
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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).
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baseline (14 weeks) and 35-37 weeks
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Insulin Sensitivity
Aikaikkuna: baseline(14 weeks) and 35-37 weeks
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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.
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baseline(14 weeks) and 35-37 weeks
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Insulin Resistance (IR)
Aikaikkuna: Baseline (14 weeks) and 35 weeks
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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
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Birth Weight
Aikaikkuna: Delivery
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Neonatal Body measurements
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Delivery
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Birth Length
Aikaikkuna: Delivery
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Neonate birth measures
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Delivery
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Head Circumference
Aikaikkuna: Delivery
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Neonate birth measures
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Delivery
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Neonate Percent Body Fat
Aikaikkuna: Delivery
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Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
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Delivery
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Infant Weight
Aikaikkuna: 1 year
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Infant Body measurements
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1 year
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Infant Length
Aikaikkuna: 1 year
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Infant body measurement
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1 year
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Linda V Van Horn, PhD, Northwestern University
- Päätutkija: Alan Peaceman, MD, Northwestern Memorial Hospital
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DK10-014
- 1U01HL114344-01 (Yhdysvaltain NIH-apuraha/sopimus)
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