Interventions to Reduce Excess Weight Gain in Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Tufts University
Sponsor:
Information provided by (Responsible Party):
Susan Roberts, Tufts University
ClinicalTrials.gov Identifier:
NCT01643356
First received: July 16, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Overweight and Obesity
Pregnancy
Behavioral: Intervention to reduce excess weight gain during pregnancy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Interventions to Reduce Excess Weight Gain in Pregnancy in Overweight and Obese Mothers

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Maternal and Infant Body Weight Change [ Time Frame: From first trimester through 1 year post-partum ] [ Designated as safety issue: No ]
    • 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:
  • Infant Outcomes [ Time Frame: From birth through first year ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: First trimester through 1 year post-partum ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 75
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643356

Contacts
Contact: Lorien E Urban, Ph.D. 617-556-3033 PregWeight@tufts.edu

Locations
United States, Massachusetts
Tufts University Human Nutrition Research Center on Aging Recruiting
Boston, Massachusetts, United States, 02111
Contact: Susan B Roberts, Ph.D.    617-556-3238    susan.robers@tufts.edu   
Contact: Sai Krupa Das, Ph.D.    617-556-3313    sai.das@tufts.edu   
Sub-Investigator: Edward Saltzman, M.D.         
Sub-Investigator: Sai Krupa Das, Ph.D.         
Principal Investigator: Susan B Roberts, Ph.D.         
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Errol Norwitz, M.D.    617-636-2382    enorwitz@tuftsmedicalcenter.org   
Contact: Sarbattama Sen, M.D.       SSen@tuftsmedicalcenter.org   
Sub-Investigator: Errol Norwitz, M.D.         
Sub-Investigator: Sarbattama Sen, M.D.         
Sub-Investigator: John Griffith, Ph.D.         
Sub-Investigator: Diana Bianchi, M.D.         
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Susan B Roberts, Ph.D. Tufts University
  More Information

No publications provided

Responsible Party: Susan Roberts, Director, Energy Metabolism Laboratory, Tufts University
ClinicalTrials.gov Identifier: NCT01643356     History of Changes
Other Study ID Numbers: 10203 Tufts
Study First Received: July 16, 2012
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
weight
pregnancy
behavioral intervention
obesity

Additional relevant MeSH terms:
Obesity
Weight Gain
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 26, 2014