Clinical trial NCT01631747: Maternal-Offspring Metabolics:Family Intervention Trial
Official title: Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Weight Gain
Keywords: Pregnancy
Weight gain
Obesity
Pregnancy and weight gain
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-06-29
Enrollment: 281
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Gestational Weight Gain (GWG)
timeFrame: 14-37 weeks
Secondary outcomes:
measure: Percentage of Participants With Gestational Diabetes
timeFrame: 24-26 weeks
measure: Fasting Glucose
timeFrame: 14-37 wks
measure: High-density Lipoprotein (HDL)
timeFrame: 14-37 wks
measure: Low-density Lipoprotein (LDL)
timeFrame: 14-37 weeks
measure: Total Cholesterol
timeFrame: 14-37 Weeks
measure: Triglycerides
timeFrame: 14-37 Weeks
measure: Leptin
timeFrame: 14-37 weeks
measure: Steady State Beta Cell Function
timeFrame: baseline (14 weeks) and 35-37 weeks
measure: Insulin Sensitivity
timeFrame: baseline(14 weeks) and 35-37 weeks
measure: Insulin Resistance (IR)
timeFrame: Baseline (14 weeks) and 35 weeks
measure: Birth Weight
timeFrame: Delivery
measure: Birth Length
timeFrame: Delivery
measure: Head Circumference
timeFrame: Delivery
measure: Neonate Percent Body Fat
timeFrame: Delivery
measure: Infant Weight
timeFrame: 1 year
measure: Infant Length
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital; Prentice Women's
state: Illinois
city: Chicago
country: United States
facility: Northwestern University: Dept of Preventive Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Linda V Van Horn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern Memorial Hospital
name: Alan Peaceman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.