Interventions to Reduce Excess Weight Gain in Pregnancy

Not Applicable

Completed

• Conditions: Overweight and Obesity; Pregnancy
• Interventions: Behavioral: Intervention to reduce excess weight gain during pregnancy

• Registration Number: NCT01643356
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Primary Completion: 2014-09
• Study Completion: 2015-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiber Cereal	Intervention to reduce excess weight gain during pregnancy	Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided high fiber cereal to manage hunger.
Resistant Starch	Intervention to reduce excess weight gain during pregnancy	Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided resistant starch to control hunger

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Tufts University Human Nutrition Research Center on Aging; 🇺🇸 Boston, Massachusetts, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States