N/A
N=281
Maternal-Offspring Metabolics:Family Intervention Trial
Pregnancy · Weight Gain
Bottom Line
View on ClinicalTrials.gov: NCT01631747 ↗Enrolled (actual)
281
Serious AEs
16.7%
Results posted
Sep 2018
Primary outcome: Primary: Gestational Weight Gain (GWG) — 12; 10 kg — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle Intervention Group (Behavioral); Usual Care Group (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gestational Weight Gain (GWG) |
12; 10 | 0.01 sig |
| SECONDARY Percentage of Participants With Gestational Diabetes |
9; 7 | 0.54 |
| SECONDARY Fasting Glucose |
87; 86; 85; 84 | 0.89 |
| SECONDARY High-density Lipoprotein (HDL) |
66; 71; 68; 70 | 0.30 |
| SECONDARY Low-density Lipoprotein (LDL) |
95; 94; 146; 130 | 0.69 |
| SECONDARY Total Cholesterol |
188; 185; 255; 252 | 0.19 |
| SECONDARY Triglycerides |
108; 109; 235; 223 | 0.27 |
| SECONDARY Leptin |
49; 50; 59; 54 | 0.003 sig |
| SECONDARY Steady State Beta Cell Function |
120; 121; 174; 159 | 0.24 |
| SECONDARY Insulin Sensitivity |
78; 87; 51; 62 | 0.32 |
| SECONDARY Insulin Resistance (IR) |
1.3; 1.2; 2.0; 1.6 | 0.26 |
| SECONDARY Birth Weight |
3213; 3244 | 0.62 |
| SECONDARY Birth Length |
51; 51 | 0.61 |
| SECONDARY Head Circumference |
34; 34 | 0.42 |
| SECONDARY Neonate Percent Body Fat |
11.9; 11.2 | 0.25 |
| SECONDARY Infant Weight |
9.9; 9.9 | 0.66 |
| SECONDARY Infant Length |
76.3; 76.2 | 0.94 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01631747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.