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
Abstract Background Excess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention. To date, only intensive interventions have had success and few interventions have...
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doaj-00ab6bfdf0b748ff88b4d328f4ad9d7d2020-11-25T03:35:27ZengBMCBMC Pregnancy and Childbirth1471-23932019-04-0119111210.1186/s12884-019-2293-8Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesitySusan D. Brown0Monique M. Hedderson1Samantha F. Ehrlich2Maren N. Galarce3Ai-Lin Tsai4Charles P. Quesenberry5Assiamira Ferrara6Division of Research, Kaiser Permanente Northern CaliforniaDivision of Research, Kaiser Permanente Northern CaliforniaDivision of Research, Kaiser Permanente Northern CaliforniaDivision of Research, Kaiser Permanente Northern CaliforniaDivision of Research, Kaiser Permanente Northern CaliforniaDivision of Research, Kaiser Permanente Northern CaliforniaDivision of Research, Kaiser Permanente Northern CaliforniaAbstract Background Excess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention. To date, only intensive interventions have had success and few interventions have been designed for implementation in healthcare settings. Methods We describe the development, rationale, and methods of GLOW (GestationaL Weight Gain and Optimal Wellness), a randomized controlled trial evaluating the efficacy of a lifestyle intervention to prevent excess GWG among racially/ethnically diverse women with overweight or obesity in an integrated healthcare delivery system. Participants in Kaiser Permanente Northern California will be randomized, within 2 weeks of completing a study baseline clinic visit at 10 weeks’ gestation, to either usual medical care or a multi-component pregnancy lifestyle intervention adapted from the Diabetes Prevention Program (target N = 400). Informed by focus groups with patients and designed to be feasible in a clinical setting, the intervention will include 13 weekly individual sessions (11 delivered by telephone) focused on behavior change for weight management, healthy eating, physical activity, and stress management. Outcomes will be assessed in women and their infants from randomization to 12 months postpartum. The primary outcome is GWG. Secondary outcomes include changes in diet and physical activity during pregnancy and infant birthweight. Exploratory outcomes include cardiometabolic profile assessed via pregnancy blood samples and cord blood samples; and postpartum weight retention and infant anthropometrics up to 12 months of age. The trial includes systematic approaches to enhance intervention fidelity, intervention adherence, and participant retention in trial assessments. Discussion GLOW is among few trials targeting excess GWG among diverse women with overweight or obesity in a healthcare setting, with long-term maternal and infant outcomes assessed up to 12 months after delivery. This evaluation of a multi-component intervention is designed to produce generalizable results to inform potential adoption of the intervention in clinical settings. Trial registration ClinicalTrials.gov (NCT02130232): submitted April 30, 2014; posted May 5, 2014.http://link.springer.com/article/10.1186/s12884-019-2293-8PregnancyObesityGestational weight gainLifestyle interventionClinical trialProtocol |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Susan D. Brown Monique M. Hedderson Samantha F. Ehrlich Maren N. Galarce Ai-Lin Tsai Charles P. Quesenberry Assiamira Ferrara |
spellingShingle |
Susan D. Brown Monique M. Hedderson Samantha F. Ehrlich Maren N. Galarce Ai-Lin Tsai Charles P. Quesenberry Assiamira Ferrara 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 and Childbirth Pregnancy Obesity Gestational weight gain Lifestyle intervention Clinical trial Protocol |
author_facet |
Susan D. Brown Monique M. Hedderson Samantha F. Ehrlich Maren N. Galarce Ai-Lin Tsai Charles P. Quesenberry Assiamira Ferrara |
author_sort |
Susan D. Brown |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
BMC Pregnancy and Childbirth |
issn |
1471-2393 |
publishDate |
2019-04-01 |
description |
Abstract Background Excess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention. To date, only intensive interventions have had success and few interventions have been designed for implementation in healthcare settings. Methods We describe the development, rationale, and methods of GLOW (GestationaL Weight Gain and Optimal Wellness), a randomized controlled trial evaluating the efficacy of a lifestyle intervention to prevent excess GWG among racially/ethnically diverse women with overweight or obesity in an integrated healthcare delivery system. Participants in Kaiser Permanente Northern California will be randomized, within 2 weeks of completing a study baseline clinic visit at 10 weeks’ gestation, to either usual medical care or a multi-component pregnancy lifestyle intervention adapted from the Diabetes Prevention Program (target N = 400). Informed by focus groups with patients and designed to be feasible in a clinical setting, the intervention will include 13 weekly individual sessions (11 delivered by telephone) focused on behavior change for weight management, healthy eating, physical activity, and stress management. Outcomes will be assessed in women and their infants from randomization to 12 months postpartum. The primary outcome is GWG. Secondary outcomes include changes in diet and physical activity during pregnancy and infant birthweight. Exploratory outcomes include cardiometabolic profile assessed via pregnancy blood samples and cord blood samples; and postpartum weight retention and infant anthropometrics up to 12 months of age. The trial includes systematic approaches to enhance intervention fidelity, intervention adherence, and participant retention in trial assessments. Discussion GLOW is among few trials targeting excess GWG among diverse women with overweight or obesity in a healthcare setting, with long-term maternal and infant outcomes assessed up to 12 months after delivery. This evaluation of a multi-component intervention is designed to produce generalizable results to inform potential adoption of the intervention in clinical settings. Trial registration ClinicalTrials.gov (NCT02130232): submitted April 30, 2014; posted May 5, 2014. |
topic |
Pregnancy Obesity Gestational weight gain Lifestyle intervention Clinical trial Protocol |
url |
http://link.springer.com/article/10.1186/s12884-019-2293-8 |
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