Interventions to Reduce Excess Weight Gain in Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643356
• Other study ID #: 10203 Tufts
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: May 9, 2016
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Pregnancy
• Weight Gain

Intervention

Behavioral:
• Intervention 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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Tufts University Human Nutrition Research Center on Aging	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal and Infant Body Weight Change	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.	From first trimester through 1 year post-partum	No
Secondary	Infant Outcomes	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.	From birth through first year	No
Secondary	Maternal and Perinatal Outcomes	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.	First trimester through 1 year post-partum	No