We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preventing Excessive Gestational Weight Gain in Obese Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01545934
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Obesity Behavioral: Lifestyle intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Excessive Gestational Weight Gain in Obese Women
Study Start Date : November 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Weight gain per week of observation [ Time Frame: 13 weeks gestation, 35 weeks gestation ]
    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 :
  1. Offspring weight gain [ Time Frame: 1 week, 6 months, 12 months ]
    Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.

  2. Changes in maternal dietary intake [ Time Frame: 13 weeks gestation, 34 weeks gestatation, 6 months postpartum, 12 months postpartum ]
    Changes in maternal calorie intake (Kcal/day) and fat intake (% kcal from fat).

  3. Changes in offspring dietary intake [ Time Frame: 1 week, 6 months, 12 months ]
    Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).

  4. Changes in maternal glucose, insulin, and lipids [ Time Frame: 13 weeks gestation, 34 weeks gestation, 6 months postpartum. 12 months postpartum ]
  5. Proportion of women exceeding IOM guidelines [ Time Frame: 13 weeks, 40 weeks ]
    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.

  6. Proportion of women at or below prepregnancy weight [ Time Frame: 22-30 weeks post delivery, 48-56 weeks post delivery ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Over 18 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545934


Locations
United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93401
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Brown University
Investigators
Principal Investigator: Suzanne Phelan, PhD Cal Poly
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Suzanne Phelan, 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