Department of Public Health, Aarhus University, Aarhus, Denmark
Health Promotion Research, Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
BMJ Open Diabetes Res Care. 2023 Oct;11(5). doi: 10.1136/bmjdrc-2023-003529.
Face-it is a randomized controlled trial for women with recent gestational diabetes mellitus (GDM) and their families designed to evaluate the effect of a health promotion intervention on type 2 diabetes mellitus (T2DM) risk and quality of life. This study examined (1) the penetration and participation rates for the Face-it trial, (2) the characteristics of the participating women and the potential differences in characteristics according to partner participation status, and (3) representativity of the women at baseline.
We identified women with GDM during pregnancy and invited them and their partners to a baseline examination 10-14 weeks after delivery. Representativity was assessed by comparing the baseline participants with non-participating women, the general population of women with GDM delivering in Denmark, and populations from other intervention trials.
The penetration rate was 38.0% (867/2279) and the participation rate was 32.9% (285/867). The 285 women who attended baseline had a mean age of 32.7 (±4.8) years and body mass index (BMI) of 28.1 (±5.4) kg/m, and 69.8% had a partner who participated. The women participating with a partner were more often primiparous, born in Denmark (82.8% vs 68.2%), were younger, and more often had a BMI ≤24.9 kg/m (35.7% vs 21.2%) compared with women without a partner. Compared with the general population of women with GDM in Denmark, these women broadly had similar degree of heterogeneity, but had higher rates of primiparity and singleton deliveries, and lower rates of preterm delivery and prepregnancy obesity.
The penetration and participation rates were acceptable. We found a high rate of partner participation. Overall, women participating with a partner were comparable with those participating without a partner. Participating women were broadly similar to the general national GDM population, however with prepregnancy obesity, multiparity, preterm delivery, and multiple pregnancy being less represented.
NCT03997773.
Face-it 是一项针对近期患有妊娠糖尿病（GDM）的女性及其家庭的随机对照试验，旨在评估健康促进干预对 2 型糖尿病（T2DM）风险和生活质量的影响。本研究考察了（1）Face-it 试验的渗透和参与率，（2）参与女性的特征以及根据伴侣参与状况的潜在差异，以及（3）基线时女性的代表性。
我们在怀孕期间确定了患有 GDM 的女性，并邀请她们及其伴侣在产后 10-14 周进行基线检查。通过将基线参与者与未参与的女性、丹麦分娩的 GDM 一般人群以及其他干预试验的人群进行比较，评估了代表性。
渗透率为 38.0%（2279 名中的 867 名），参与率为 32.9%（867 名中的 285 名）。参加基线检查的 285 名女性平均年龄为 32.7（±4.8）岁，体重指数（BMI）为 28.1（±5.4）kg/m，69.8%的女性有伴侣参与。与没有伴侣的女性相比，有伴侣参与的女性更常是初产妇，出生于丹麦（82.8%对 68.2%），年龄更小，且 BMI≤24.9kg/m 的比例更高（35.7%对 21.2%）。与丹麦 GDM 一般人群相比，这些女性的异质性程度大致相似，但初产率和单胎分娩率较高，早产率和孕前肥胖率较低。
渗透和参与率是可以接受的。我们发现伴侣参与率很高。总体而言，有伴侣参与的女性与没有伴侣参与的女性基本相似。参与的女性与一般全国 GDM 人群基本相似，但孕前肥胖、多胎妊娠、早产和多胎妊娠的代表性较低。
NCT03997773。
