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Trial record 1 of 1 for:    01545934
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Preventing Excessive Gestational Weight Gain in Obese Women

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ClinicalTrials.gov Identifier: NCT01545934
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Results First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Suzanne Phelan, California Polytechnic State University-San Luis Obispo

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 Phase
Obesity Behavioral: Lifestyle intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Excessive Gestational Weight Gain in Obese Women
Actual Study Start Date : November 2012
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.




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. Kcals/Day [ Time Frame: 13 weeks gestation, 34 weeks gestation ]
    Changes in maternal calorie intake (Kcal/day)

  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 [ Time Frame: 13 weeks gestation, 34 weeks gestation ]
    Fasting glucose

  5. Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. [ Time Frame: 13 weeks, 40 weeks ]
    Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding 2009 IOM guidelines if the difference is > 11.5 kg gain for women with prepregnancy overweight or >9 kg for women with prepregnancy obesity.

  6. Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group [ Time Frame: 48-56 weeks post delivery ]
    Weight measured at 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Suzanne Phelan, PhD Cal Poly
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Suzanne Phelan, Principle Investigator, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT01545934    
Other Study ID Numbers: U01 HL114377A
First Posted: March 7, 2012    Key Record Dates
Results First Posted: January 28, 2021
Last Update Posted: January 28, 2021
Last Verified: January 2021
Keywords provided by Suzanne Phelan, California Polytechnic State University-San Luis Obispo:
Overweight
Obese
Pregnancy
Weight Gain
Additional relevant MeSH terms:
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Weight Gain
Gestational Weight Gain
Body Weight Changes
Body Weight