Protocol for a randomised controlled trial of a co-produced, complex, health promotion intervention for women with prior gestational diabetes and their families: the Face-it study

Karoline Kragelund Nielsen, Inger Katrine Dahl-Petersen, Dorte Møller Jensen, Per Ovesen, Peter Damm, Nanna Husted Jensen, Maja Thøgersen, Anne Timm, Line Hillersdal, Ulla Kampmann, Christina Anne Vinter, Elisabeth Reinhardt Mathiesen, Helle Terkildsen Maindal, Face-it Study Group, Karoline Kragelund Nielsen, Inger Katrine Dahl-Petersen, Dorte Møller Jensen, Per Ovesen, Peter Damm, Nanna Husted Jensen, Maja Thøgersen, Anne Timm, Line Hillersdal, Ulla Kampmann, Christina Anne Vinter, Elisabeth Reinhardt Mathiesen, Helle Terkildsen Maindal, Face-it Study Group

Abstract

Background: Gestational diabetes mellitus (GDM) is associated with an increased risk of future diabetes in both mother, father and offspring. More knowledge is needed about how to effectively reduce the risk of diabetes through sustained behavioural interventions in these families. The Face-it intervention is a complex health promotion intervention embedded in multi-level supportive environments. The aim of the intervention is to reduce type 2 diabetes risk and increase quality of life among families in the first year following a GDM-affected pregnancy by promoting physical activity, healthy dietary behaviours and breastfeeding through a focus on social support, motivation, self-efficacy, risk perception and health literacy.

Methods: This national multicentre study is a two-arm randomised controlled trial including 460 women with GDM in a ratio of 2 (intervention):1 (usual care). The Face-it intervention consists of three main components: 1) additional visits from municipal health visitors, 2) digital health coaching tailored to family needs and 3) a structured cross-sectoral communication system in the health care system. The intervention runs from 3 to 12 months after delivery. The primary outcome is maternal body mass index at 12 months after delivery as a proxy for diabetes risk. The women will be examined at baseline and at follow-up, and this examination will include blood tests, oral glucose tolerance test (OGTT), anthropometrics, blood pressure, self-reported diet and physical activity, breastfeeding, quality of life, health literacy, physical and mental health status, risk perception and social support. Aside from those data collected for OGTT and breastfeeding and offspring parameters, the same data will be collected for partners. Data on offspring anthropometry will also be collected. Information on pregnancy- and birth-related outcomes will be derived from the medical records of the woman and child.

Discussion: This randomised controlled trial seeks to demonstrate whether the Face-it intervention, addressing the individual, family and health care system levels, is superior to usual care in reducing diabetes risk for mothers and their families. Coupled with a process evaluation and an economic analysis, the study will provide evidence for policymakers and health services about health promotion among families affected by GDM and the potential for reducing risk of type 2 diabetes and associated conditions.

Trial registration: ClinicalTrials.gov NCT03997773. Registered June 25, 2019 - Retrospectively registered.

Keywords: Gestational diabetes mellitus, Type 2 diabetes prevention, Postpartum period, Family intervention, Complex intervention, Health promotion, Cross-disciplinary research.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram for Face-it showing participant flow through the phases of the randomised controlled trial

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