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

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 crosssectoral 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 birthrelated outcomes will be derived from the medical records of the woman and child.

Systematically developing a family-based health promotion intervention for women with prior gestational diabetes based on evidence, theory and co-production: the Face-it study

“…We met with the health visitor management in one of the municipalities and presented our current principles on how to promote health in families where the mother had GDM, e.g. focusing on the broad health concept of WHO, social support, motivation, self-e cacy, risk perception and health literacy (44). This led the health visitors to introduce a health pedagogic tool: the family wheel.…”

“…The questionnaire contained both validated scales and self-constructed questions building on qualitative evidence from the earlier stages of intervention development. The full list of measurements is available in the trial protocol (44). The ndings from the previous stages informed the need to include various psychosocial outcomes.…”

“…After identifying the outcomes and nalising the intervention content and modes of delivery, we estimated sample size as well as recruitment and retention rates and nalised the study protocol. The details are available in the published study protocol (44).…”

“…We have planned, training days for both intervention delivers and those recruiting and conducting clinical examinations. The training is based on co-production principles, including the possibility of further adaptation the intervention content without compromising the core of the intervention required for the trial period (44). Wherever possible, the training days will ensure ongoing involvement and transparency in decisions made in the study.…”

Calidad de vida y salud: factores asociados en mujeres con diabetes mellitus gestacional

“…Calidad de vida significa literalmente cómo vivir, y en la definición científica de la OMS significa la percepción del individuo de la situación actual con respecto a la cultura y el sistema de valores en que vive y su relación con los objetivos, expectativas, normas y prioridades del individuo (Carroll et al, 2018). La calidad de vida es un factor subjetivo, multidimensional y dinámico que es la combinación de factores cognitivos como la satisfacción y sentimientos como la felicidad (Nielsen et al, 2020).…”