Evaluation of a computer-assisted multi-professional intervention to address lifestyle-related risk factors for overweight and obesity in expecting mothers and their infants: protocol for an effectiveness-implementation hybrid study

Adrienne Alayli,Elena Tschiltschke,Anne-Madeleine Bau,Christian Giertz,Laura Lorenz,Benny Häusler,Stefan Klose,Michael John,Franziska Krebs,Andrea Moreira,Judith Kuchenbecker,Farah Nawabi,Stephanie Stock,Ulrike Korsten-Reck,Isabel Lück

doi:10.1186/s12889-020-8200-4

Abstract

BackgroundThe first 1000 days after conception are a critical period to encourage lifestyle changes to reduce the risk of childhood obesity and early programming of chronic diseases. A healthy lifestyle during pregnancy is also crucial to avoid high post-partum weight retention. Currently, lifestyle changes are not consistently discussed during routine health services in Germany. The objective of this study is to evaluate a novel computer-assisted lifestyle intervention embedded in prenatal visits and infant check-ups. The intervention seeks to reduce lifestyle-related risk factors for overweight and obesity among expecting mothers and their infants.MethodsThe study is designed as a hybrid effectiveness-implementation trial to simultaneously collect data on the effectiveness and implementation of the lifestyle intervention. The trial will take place in eight regions of the German state Baden-Wuerttemberg. Region were matched using propensity score matching. Expecting mothers (n = 1860) will be recruited before 12 weeks of gestation through gynecological practices and followed for 18 months. During 11 routine prenatal visits and infant check-ups gynecologists, midwives and pediatricians provide lifestyle counseling using Motivational Interviewing techniques. The primary outcome measure is the proportion of expecting mothers with gestational weight gain within the recommended range. To understand the process of implementation (focus group) interviews will be conducted with providers and participants of the lifestyle intervention. Additionally, an analysis of administrative data and documents will be carried out. An economic analysis will provide insights into cost and consequences compared to routine health services.DiscussionFindings of this study will add to the evidence on lifestyle interventions to reduce risk for overweight and obesity commenced during pregnancy. Insights gained will contribute to the prevention of early programming of chronic disease. Study results regarding implementation fidelity, adoption, reach and cost-effectiveness of the lifestyle intervention will inform decisions about scale up and public funding.Trial registrationGerman Clinical Trials Register (DRKS00013173). Registered 3rd of January 2019, https://www.drks.de

Highlights

Overweight and obesity are increasing worldwide [1]
Findings of this study will add to the evidence on lifestyle interventions to reduce risk for overweight and obesity commenced during pregnancy
Insights gained will contribute to the prevention of early programming of chronic disease

Summary

Introduction

More than one in two adults and nearly one in six children are overweight or obese in OECD countries [2]. In Germany 35.9% of the adult population are overweight and 18.1% are obese [3]. The high prevalence of overweight and obesity represents a key risk factor for non-communicable diseases, including cardiovascular diseases, diabetes, musculoskeletal disorders and some cancers [1]. As childhood overweight and obesity tend to persist into adulthood [5], early interventions are essential. The first 1000 days after conception are a critical period to encourage lifestyle changes to reduce the risk of childhood obesity and early programming of chronic diseases. The intervention seeks to reduce lifestylerelated risk factors for overweight and obesity among expecting mothers and their infants

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