Maternal-Offspring Metabolics:Family Intervention Trial
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/8/2018 |
| Start Date: | November 2012 |
| End Date: | July 31, 2017 |
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.
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.
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
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
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
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