Interventions to Reduce Excess Weight Gain in Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Overweight and Obesity
• Intervention / Treatment: Behavioral: Intervention to reduce excess weight gain during pregnancy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts University Human Nutrition Research Center on Aging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fiber Cereal; Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided high fiber cereal to manage hunger.	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.
No Intervention: Control Group; Women assigned to this arm of the study will receive routine clinical care and no additional interventions.
Active Comparator: Resistant Starch; Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided resistant starch to control hunger	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Susan B Roberts, Ph.D., Tufts University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: behavioral intervention; obesity; pregnancy; weight
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Overweight; Weight Gain
• Other Study ID Numbers: 10203 Tufts