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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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