Interventions to Reduce Excess Weight Gain in Pregnancy in Overweight and Obese Mothers

Tufts University2 sites in 1 country50 target enrollmentJuly 2012

ConditionsOverweight and Obesity Pregnancy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Overweight and Obesity
Sponsor: Tufts University
Enrollment: 50
Locations: 2
Primary Endpoint: Maternal and Infant Body Weight Change
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

September 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Tufts University

Responsible Party

Principal Investigator

Susan Roberts

Director, Energy Metabolism Laboratory

Tufts University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Maternal and Infant Body Weight Change

Time Frame: 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.