Preventing Excessive Gestational Weight Gain in Obese Women

This study is currently recruiting participants.
Verified September 2013 by California Polytechnic State University-San Luis Obispo
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Suzanne Phelan, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier:
NCT01545934
First received: February 28, 2012
Last updated: September 9, 2013
Last verified: September 2013

February 28, 2012
September 9, 2013
November 2012
March 2016   (final data collection date for primary outcome measure)
Weight gain per week of observation [ Time Frame: 13 weeks gestation, 35 weeks gestation ] [ Designated as safety issue: No ]
Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.
Weight change in pregnancy [ Time Frame: 13 weeks gestation, 34 weeks gestation, 40 weeks gestation ] [ Designated as safety issue: No ]
Weight changes in kg from study entry (13 weeks gestation on average) to 34 and 40 weeks gestation
Complete list of historical versions of study NCT01545934 on ClinicalTrials.gov Archive Site
  • Offspring weight gain [ Time Frame: 1 week, 6 months, 12 months ] [ Designated as safety issue: No ]
    Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.
  • Changes in maternal dietary intake [ Time Frame: 13 weeks gestation, 34 weeks gestatation, 6 months postpartum, 12 months postpartum ] [ Designated as safety issue: No ]
    Changes in maternal calorie intake (Kcal/day) and fat intake (% kcal from fat).
  • Changes in offspring dietary intake [ Time Frame: 1 week, 6 months, 12 months ] [ Designated as safety issue: No ]
    Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
  • Changes in maternal glucose, insulin, and lipids [ Time Frame: 13 weeks gestation, 34 weeks gestation, 6 months postpartum. 12 months postpartum ] [ Designated as safety issue: No ]
  • Proportion of women exceeding IOM guidelines [ Time Frame: 13 weeks, 40 weeks ] [ Designated as safety issue: No ]
    Women will be categorized as exceeding or not exceeding IOM guidelines for gestational weight gain. Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding or not exceeding 2009 IOM guidelines.
  • Proportion of women at or below prepregnancy weight [ Time Frame: 22-30 weeks post delivery, 48-56 weeks post delivery ] [ Designated as safety issue: No ]
    Weight measured at 22-30 and 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight.
  • Offspring weight gain [ Time Frame: 1 week, 6 months, 12 months ] [ Designated as safety issue: No ]
    Offpsring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.
  • Changes in maternal dietary intake [ Time Frame: 13 weeks gestation, 34 weeks gestatation, 6 months postpartum, 12 months postpartum ] [ Designated as safety issue: No ]
    Changes in maternal calorie intake (Kcal/day) and fat intake (% kcal from fat).
  • Changes in offspring dietary intake [ Time Frame: 1 week, 6 months, 12 months ] [ Designated as safety issue: No ]
    Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
  • Changes in maternal glucose, insulin, and lipids [ Time Frame: 13 weeks gestation, 34 weeks gestation, 6 months postpartum. 12 months postpartum ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Preventing Excessive Gestational Weight Gain in Obese Women
Preventing Excessive Gestational Weight Gain in Obese Women

The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Obesity
Behavioral: Lifestyle intervention
The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
  • No Intervention: Standard Care
  • Experimental: Lifestyle intervention
    Intervention: Behavioral: Lifestyle intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
June 2017
March 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

  • 18-40 years old
  • < 16 weeks gestation
  • BMI >= 25
  • Willing to consent

Exclusion Criteria:

  • Pregnant with Twins
  • Untreated medical or psychological problem
  • Inability to be physically active
Female
18 Years to 40 Years
Yes
Contact: Suzanne Phelan, PhD 805-756-2087 sphelan@calpoly.edu
Contact: Anna C Brannen, B.S. 805-756-5365 acbranne@calpoly.edu
United States
 
NCT01545934
U01 HL114377A
Yes
Suzanne Phelan, California Polytechnic State University-San Luis Obispo
California Polytechnic State University-San Luis Obispo
Brown University
Principal Investigator: Suzanne Phelan, PhD Cal Poly
California Polytechnic State University-San Luis Obispo
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP