A counselling intervention for individual strategies to prevent complications and strengthen resources during pregnancy in gynaecological care (AOK-Family +): study protocol for a cluster-randomised controlled trial

Trials. 2024 Jun 18;25(1):393. doi: 10.1186/s13063-024-08215-5.

Abstract

Background: Lifestyle-related risk factors can increase complications during pregnancy and negatively impact the health of a mother and her child. Knowledge about these compliances among many pregnant women and women of childbearing age is lacking. In the study AOK-Family + , we propose the evaluation of a newly developed counselling intervention. The intervention aims to raise awareness and to provide relevant information about the impact of lifestyle-related risk factors during pregnancy. The aim of the proposed study is to evaluate the effect of this counselling intervention on women's knowledge of lifestyle-related risk factors during pregnancy and the concomitant healthy behaviours.

Methods: A cluster-randomised trial with three arms in Baden-Wuerttemberg, Germany, is proposed. Pregnant women and women of childbearing age will be allocated to one of three groups: online intervention, on-site intervention, or a waiting-list control. Trained counsellors from AOK Baden-Wuerttemberg, a German statutory health insurer, will conduct the counselling sessions. Data collection is conducted throughout validated questionnaires administered at three intervals: before counselling (t0), directly after counselling (t1), and at a 6-week follow-up (t2). The primary outcomes will be health knowledge and healthy behaviours relating to LRFFs during pregnancy. A process evaluation will examine the processes, used resources, and future implementations through additional quantitative questions and qualitative interviews and focus groups.

Discussion: Based on this study, an implementation strategy for future conduction of lifestyle consultation during pregnancy could be developed with the aim of reducing pre- and post-mortem mobility and mortality.

Trial registration: The German Clinical Trials Register DRKS00027804. Registered on 2022/01/12.

Keywords: Health behaviours; Health knowledge; Health literacy; Pregnancy; Prevention.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Counseling*
  • Female
  • Germany
  • Health Behavior
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Pregnancy
  • Pregnancy Complications* / prevention & control
  • Randomized Controlled Trials as Topic*
  • Risk Factors
  • Risk Reduction Behavior