Appropriate Gestational Weight Gain in Overweight/Obese Women

Gestational Weight Gain Clinical Trial

Official title:

Appropriate Gestational Weight Gain in Overweight/Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130232
• Other study ID #: CN-13-1628
• Secondary ID: 5R01HD073572-02
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: February 2020

Study information

• Verified date: April 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: February 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Overweight
• Weight Gain

Intervention

Behavioral:
• Lifestyle Intervention

Other:
• Usual Care

Locations

Country	Name	City	State
United States	Kaiser Permanente Oakland Medical Center	Oakland	California
United States	Kaiser Permanente Santa Clara Medical Center	Santa Clara	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of gestational weight gain per week		From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Primary	Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week		from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Secondary	Total gestational weight gain		from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks
Secondary	Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week		From pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks
Secondary	Rate of gestational weight gain between study clinical assessments		Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week)
Secondary	Diet - total calories from fat		Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
Secondary	Diet - proportion of calories from fat		Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
Secondary	Physical Activity		Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Secondary	Metabolic marker - glycemia		Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Secondary	Metabolic marker - insulinemia		Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Secondary	Metabolic marker - lipids		Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Secondary	Metabolic marker - leptin		Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Secondary	Metabolic marker - adiponectin		Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)