Overweight and Obesity, Pregnancy
Conditions
Keywords
weight, pregnancy, behavioral intervention, obesity
Brief summary
The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.
Interventions
BEHAVIORALIntervention to reduce excess weight gain during pregnancy
Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed.
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-45 years * In first trimester of pregnancy * Must be willing to not join any other weight control program while in the study * BMI of 25-40 kg/m2 * Willingness and ability to attend support group meetings either in person or via web * Must be able to read, speak, and understand English
Exclusion criteria
* Carrying multiple fetuses * Gestational diabetes mellitus at study entry * Type 2 diabetes mellitus or blood glucose \>125 mg/dl at screening * Self reported current substance abuse * Current smoking * Alchol consumption of more than 1 drink per day * Preexisting medical conditions (includes bariatric surgery) or use of medications that would impact study involvement or outcomes testing * Eating disorder in the past 2 years * Depression or diagnosis of bipolar disorder * Concurrent participation in any other research study that would impact participation in this investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal and Infant Body Weight Change | From first trimester through 1 year post-partum | * Maternal non-fasting weight measured at all prenatal clinic and study visits. * Infant weight measured at birth and all pediatric clinic visits through 1 year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant Outcomes | From birth through first year | * Body composition (i.e. length, head circumference, skinfold thickness, waist circumference) changes through the first year. * Characteristics at birth including Apgar score, gestational age. * Dietary intake and food preferences at 1 year. |
| Maternal and Perinatal Outcomes | First trimester through 1 year post-partum | * Rates of cesarean delivery, gestational hypertension/preeclampsia, preterm birth, birth complications. * Fasting blood glucose and insulin concentrations throughout pregnancy. * Body composition and energy requirements at baseline and 24-28 weeks of pregnancy. * Total energy expenditure at 24-28 weeks of pregnancy. * Rate of breastfeeding and breastfeeding practices at 1, 3, 6, and 12 months post-partum. |
Countries
United States
Outcome results
None listed