- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01631747
Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
2018년 10월 13일 업데이트: 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.
연구 개요
상세 설명
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
연구 유형
중재적
등록 (실제)
281
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Illinois
-
Chicago, Illinois, 미국, 60611
- Northwestern Memorial Hospital; Prentice Women's
-
Chicago, Illinois, 미국, 60611
- Northwestern University: Dept of Preventive Medicine
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gestational Weight Gain (GWG)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With Gestational Diabetes
기간: 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
기간: 14-37 wks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 wks
|
|
High-density Lipoprotein (HDL)
기간: 14-37 wks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 wks
|
|
Low-density Lipoprotein (LDL)
기간: 14-37 weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 weeks
|
|
Total Cholesterol
기간: 14-37 Weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 Weeks
|
|
Triglycerides
기간: 14-37 Weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 Weeks
|
|
Leptin
기간: 14-37 weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 weeks
|
|
Steady State Beta Cell Function
기간: 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
기간: 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)
기간: 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
기간: Delivery
|
Neonatal Body measurements
|
Delivery
|
|
Birth Length
기간: Delivery
|
Neonate birth measures
|
Delivery
|
|
Head Circumference
기간: Delivery
|
Neonate birth measures
|
Delivery
|
|
Neonate Percent Body Fat
기간: Delivery
|
Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
|
Delivery
|
|
Infant Weight
기간: 1 year
|
Infant Body measurements
|
1 year
|
|
Infant Length
기간: 1 year
|
Infant body measurement
|
1 year
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Linda V Van Horn, PhD, Northwestern University
- 수석 연구원: Alan Peaceman, MD, Northwestern Memorial Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 11월 1일
기본 완료 (실제)
2017년 7월 31일
연구 완료 (실제)
2017년 7월 31일
연구 등록 날짜
최초 제출
2012년 6월 25일
QC 기준을 충족하는 최초 제출
2012년 6월 27일
처음 게시됨 (추정)
2012년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 11월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 10월 13일
마지막으로 확인됨
2018년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .