Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
2018年10月13日 更新者: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.
調査の概要
詳細な説明
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
研究の種類
介入
入学 (実際)
281
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern Memorial Hospital; Prentice Women's
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Chicago、Illinois、アメリカ、60611
- Northwestern University: Dept of Preventive Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~45年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ: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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実験的: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gestational Weight Gain (GWG)
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Gestational Diabetes
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠:Delivery
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Neonatal Body measurements
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Delivery
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Birth Length
時間枠:Delivery
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Neonate birth measures
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Delivery
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Head Circumference
時間枠:Delivery
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Neonate birth measures
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Delivery
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Neonate Percent Body Fat
時間枠: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
時間枠:1 year
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Infant Body measurements
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1 year
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Infant Length
時間枠:1 year
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Infant body measurement
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1 year
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Linda V Van Horn, PhD、Northwestern University
- 主任研究者:Alan Peaceman, MD、Northwestern Memorial Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年11月1日
一次修了 (実際)
2017年7月31日
研究の完了 (実際)
2017年7月31日
試験登録日
最初に提出
2012年6月25日
QC基準を満たした最初の提出物
2012年6月27日
最初の投稿 (見積もり)
2012年6月29日
学習記録の更新
投稿された最後の更新 (実際)
2018年11月6日
QC基準を満たした最後の更新が送信されました
2018年10月13日
最終確認日
2018年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。