Background: 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. 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 lifestylerelated risk factors for overweight and obesity among expecting mothers and their infants. Methods:The 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.

In health services research, the recruitment of patients is oftentimes conducted by community-based healthcare providers. Therefore, the recruitment of these healthcare providers is a crucial prerequisite for successful patient recruitment. However, recruiting community-based healthcare providers poses a major challenge and little is known about its influencing factors. This qualitative study is conducted alongside a health services research intervention trial. The aim of the study is to investigate facilitators and barriers for the recruitment of community-based healthcare providers. A qualitative text analysis of documents and semi-structured interviews with recruiting staff is performed. An inductive–deductive category-based approach is used. Our findings identify intrinsic motivation and interest in the trial’s aims and goals as important facilitating factors in healthcare provider recruitment. Beyond that, extrinsic motivation generated through financial incentives or collegial obligation emerged as a conflicting strategy. While extrinsic motivation might aid in the initial enrollment of healthcare providers, it rarely resulted in active trial participation in the long run. Therefore, extrinsic motivational factors should be handled with care when recruiting healthcare providers for health services research intervention trials.

Background In healthcare intervention trials, the recruitment of patients is frequently conducted by community-based healthcare providers. The recruitment of healthcare providers is therefore a crucial prerequisite that can determine the success of a trial right from the start. However, the recruitment of healthcare providers often poses a major challenge, and little is known about its influencing factors. Methods The study was conducted alongside an intervention trial evaluating the effectiveness of a lifestyle intervention during pregnancy. Triangulation techniques were used to identify facilitators and barriers to the recruitment of healthcare providers. Qualitative text analysis of internal documents and semi-structured interviews with study coordinators were performed. These results were used to derive the facilitating and inhibiting factors for recruitment. Results Our findings identified intrinsic motivation and interest in the trial’s aims and goals as the most important factors in healthcare provider recruitment. Beyond that, extrinsic motivation generated through financial incentives or collegial obligation emerged as a conflicting strategy. While extrinsic motivation might aid in the initial enrollment of healthcare providers, it rarely results in active trial participation in the long run. The perceived availability of eligible patients emerged as another barrier. Some healthcare providers declined trial participation because they anticipated that they would not have any patients that would suit the intervention due to high social burden or low need on the part of the patients. Conclusions During the planning of a trial, more attention should be paid to the recruitment phase. Researchers should seek input from healthcare providers when planning their trial design and recruitment strategies, and conduct a thorough needs assessment to avoid barriers and create a sense of ownership. Financial compensation for the trial burden emerged as a basic requirement, but this is not sufficient for recruitment if used as the sole means of motivation. Adaptable recruiting and intervention strategies that suit different patient populations are important in helping healthcare providers feel adequately prepared for trial tasks. The recruitment skills of healthcare providers and the communication skills of trial staff should therefore be addressed explicitly before the start of the recruitment phase. Trial registration German Clinical Trials Register (DRKS00013173). Registered 3rd of January 2019

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