Preventing Excessive Gestational Weight Gain in Obese Women

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Excessive Gestational Weight Gain in Obese Women

Resource links provided by NLM:


Further study details as provided by California Polytechnic State University-San Luis Obispo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 350
Study Start Date: November 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
Experimental: Lifestyle intervention 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01545934

Contacts
Contact: Suzanne Phelan, PhD 805-756-2087 sphelan@calpoly.edu
Contact: Anna C Brannen, B.S. 805-756-5365 acbranne@calpoly.edu

Locations
United States, California
California Polytechnic State University Recruiting
San Luis Obispo, California, United States, 93401
Contact: Suzanne Phelan, PhD.    805-756-2087    sphelan@calpoly.edu   
Contact: Anna C Brannen, B.S.    805-756-5365    acbranne@calpoly.edu   
Principal Investigator: Suzanne Phelan, PhD         
United States, Rhode Island
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Rena R Wing, Phd    401-793-8959    rwing@calpoly.edu   
Principal Investigator: Rena R Wing, PhD         
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Brown University
Investigators
Principal Investigator: Suzanne Phelan, PhD Cal Poly
  More Information

No publications provided

Responsible Party: Suzanne Phelan, Principle Investigator, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT01545934     History of Changes
Other Study ID Numbers: U01 HL114377A
Study First Received: February 28, 2012
Last Updated: September 9, 2013
Health Authority: United States: NIH

Keywords provided by California Polytechnic State University-San Luis Obispo:
Overweight
Obese
Pregnancy
Weight Gain

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014