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.
Adult
California
Counseling
/ methods
Diet, Healthy
/ methods
Female
Gestational Weight Gain
Humans
Life Style
Obesity
/ complications
Overweight
/ complications
Pregnancy
Pregnancy Complications
/ etiology
Prenatal Care
/ methods
Randomized Controlled Trials as Topic
Weight Reduction Programs
/ methods
Young Adult
Clinical trial
Gestational weight gain
Lifestyle intervention
Obesity
Pregnancy
Protocol
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
30 Apr 2019
30 Apr 2019
Historique:
received:
15
11
2018
accepted:
12
04
2019
entrez:
2
5
2019
pubmed:
2
5
2019
medline:
25
12
2019
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov ( NCT02130232 ): submitted April 30, 2014; posted May 5, 2014.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov ( NCT02130232 ): submitted April 30, 2014; posted May 5, 2014.
Identifiants
pubmed: 31039753
doi: 10.1186/s12884-019-2293-8
pii: 10.1186/s12884-019-2293-8
pmc: PMC6492416
doi:
Banques de données
ClinicalTrials.gov
['NCT02130232']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
145Subventions
Organisme : NICHD NIH HHS
ID : R01 HD073572
Pays : United States
Organisme : NIDDK NIH HHS
ID : K01 DK105106
Pays : United States
Organisme : NIDDK NIH HHS
ID : K01 DK099404
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK092924
Pays : United States
Organisme : NIDDK NIH HHS
ID : K01 DK105106
Pays : United States
Organisme : NICHD NIH HHS
ID : R01 HD073572
Pays : United States
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