Health Promotion, Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, 2820, Gentofte, Denmark.
Steno Diabetes Center Odense, Odense, Denmark.
Trials. 2020 Feb 7;21(1):146. doi: 10.1186/s13063-020-4062-4.
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.
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.
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.
ClinicalTrials.gov NCT03997773. Registered June 25, 2019 - Retrospectively registered.
妊娠糖尿病（GDM）会增加母亲、父亲和后代未来患糖尿病的风险。我们需要更多的知识，以了解如何通过对这些家庭进行持续的行为干预来有效降低糖尿病风险。Face-it 干预是一项复杂的健康促进干预措施，嵌入在多层次的支持环境中。该干预的目的是通过关注社会支持、动机、自我效能、风险感知和健康素养，促进身体活动、健康饮食行为和母乳喂养，从而降低 GDM 妊娠后第一年家庭的 2 型糖尿病风险并提高生活质量。
这项全国性的多中心研究是一项两臂随机对照试验，纳入了 460 名 GDM 女性，比例为 2（干预组）：1（常规护理组）。Face-it 干预包括三个主要组成部分：1）来自市保健员的额外访问，2）针对家庭需求的数字健康指导，以及 3）医疗保健系统中的结构化跨部门沟通系统。干预从产后 3 至 12 个月进行。主要结局是产后 12 个月时母亲的体重指数，作为糖尿病风险的替代指标。这些女性将在基线和随访时进行检查，检查内容包括血液检查、口服葡萄糖耐量试验（OGTT）、人体测量学、血压、自我报告的饮食和身体活动、母乳喂养、生活质量、健康素养、身心健康状况、风险感知和社会支持。除了 OGTT 和母乳喂养及后代参数所收集的数据外，还将为伴侣收集相同的数据。还将收集后代人体测量数据。关于妊娠和分娩相关结局的信息将从女性和儿童的医疗记录中获得。
这项随机对照试验旨在证明，针对个体、家庭和医疗保健系统层面的 Face-it 干预是否优于常规护理，从而降低 GDM 女性及其家庭的糖尿病风险。结合过程评估和经济分析，该研究将为政策制定者和卫生服务机构提供有关 GDM 家庭健康促进以及降低 2 型糖尿病和相关疾病风险的证据。
ClinicalTrials.gov NCT03997773。于 2019 年 6 月 25 日注册-回顾性注册。
