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Appropriate Gestational Weight Gain in Overweight/Obese Women

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ClinicalTrials.gov Identifier: NCT02130232
Recruitment Status : Active, not recruiting
First Posted : May 5, 2014
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.

Condition or disease Intervention/treatment Phase
Gestational Weight Gain Behavioral: Lifestyle Intervention Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Appropriate Gestational Weight Gain in Overweight/Obese Women
Study Start Date : April 2014
Actual Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Lifestyle Intervention
The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The pregnancy lifestyle intervention will be delivered by trained study dieticians via individual counseling sessions: 2 in-person and 11 telephone sessions delivered on a weekly basis, followed by telephone sessions delivered every other week through the end of pregnancy.
Behavioral: Lifestyle Intervention
Active Comparator: Usual Care
Usual Medical Care
Other: Usual Care



Primary Outcome Measures :
  1. Total Gestational Weight Gain (GWG) [ Time Frame: Total GWG ]
  2. Rate of total GWG [ Time Frame: Rate of Maternal GWG for total GWG (in kilograms per week) ]
  3. Rate of Maternal GWG between study clinical assessments [ Time Frame: Rate of Maternal GWG between approximately 10 weeks and 32 weeks gestation (kilograms per week) ]
  4. Proportion of women meeting the Institute of Medicine's gestational weight gain recommendation [ Time Frame: Maternal GWG between approximately 10 weeks and 32 weeks gestation ]

Secondary Outcome Measures :
  1. Diet [ Time Frame: Change in diet between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) ]
  2. Physical Activity [ Time Frame: Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) ]
  3. Body Fat [ Time Frame: Change in body fat mass between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant
  • Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record)

Exclusion Criteria:

  • Diabetes
  • Cardiovascular disease
  • Gastrointestinal disease
  • Bariatric surgery
  • Lung disease
  • Thyroid disease
  • Eating disorder
  • Cancer
  • Bed rest or Gestational Diabetes in the current pregnancy
  • Planning to get pregnant again or move within 1 year of delivery
  • Substance abuse
  • Serious mental health disorders

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): NCT02130232


Locations
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United States, California
Kaiser Permanente Oakland Medical Center
Oakland, California, United States, 94611
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, United States, 95051
Sponsors and Collaborators
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Assiamira Ferrara, MD PhD Kaiser Permanente Division of Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02130232     History of Changes
Other Study ID Numbers: CN-13-1628
5R01HD073572-02 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by Kaiser Permanente:
Gestational weight gain
Lifestyle
Intervention
Additional relevant MeSH terms:
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Body Weight
Overweight
Weight Gain
Gestational Weight Gain
Signs and Symptoms
Body Weight Changes