Clinical trial NCT02130232: Appropriate Gestational Weight Gain in Overweight/Obese Women
Official title: Appropriate Gestational Weight Gain in Overweight/Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Weight Gain
Keywords: Gestational weight gain
Lifestyle
Intervention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-05-05
Enrollment: 398
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Rate of gestational weight gain per week
timeFrame: From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy
measure: Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week
timeFrame: from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Secondary outcomes:
measure: Total gestational weight gain
timeFrame: from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks
measure: Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week
timeFrame: From pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks
measure: Rate of gestational weight gain between study clinical assessments
timeFrame: Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week)
measure: Diet - total calories from fat
timeFrame: Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
measure: Diet - proportion of calories from fat
timeFrame: Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
measure: Physical Activity
timeFrame: Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
measure: Metabolic marker - glycemia
timeFrame: Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
measure: Metabolic marker - insulinemia
timeFrame: Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
measure: Metabolic marker - lipids
timeFrame: Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
measure: Metabolic marker - leptin
timeFrame: Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
measure: Metabolic marker - adiponectin
timeFrame: Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Oakland Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente Division of Research
name: Assiamira Ferrara, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005.
citation: Ferrara A, Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Feng J, Galarce M, Marcovina S, Catalano P, Quesenberry CP. A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):490-500. doi: 10.1016/S2213-8587(20)30107-8.
citation: Brown SD, Hedderson MM, Ehrlich SF, Galarce MN, Tsai AL, Quesenberry CP, Ferrara A. Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesity. BMC Pregnancy Childbirth. 2019 Apr 30;19(1):145. doi: 10.1186/s12884-019-2293-8.