Goldstein Rebecca F, Boyle Jacqueline A, Cooray Shamil D, Joham Anju E, Fitz-Gerald Alison L, Enticott Joanne, Harrison Cheryce L, Teede Helena J
Diabetes and Vascular Medicine Unit, Monash Health, Melbourne, Victoria, Australia.
Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
Obesity (Silver Spring). 2025 Jan;33(1):54-66. doi: 10.1002/oby.24192. Epub 2024 Dec 10.
The objective of this study was to evaluate a lifestyle intervention implemented into routine antenatal care to optimize gestational weight gain (GWG) and outcomes using the Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM) framework.
This study was an embedded pragmatic behavioral intervention delivered by a health coach and supported by a physician over five sessions for women with a prepregnancy BMI between 25 and 43 kg/m who were <23 weeks' gestation in an Australian maternity service. Both intervention and standard care received routine antenatal care. The primary outcome was effectiveness in reducing excess GWG, and the secondary outcomes were reach, adoption, implementation, and maintenance and maternal and neonatal outcomes using the RE-AIM framework.
For the "Reach" aspect, 90% of eligible women were included (N = 404; n = 202 intervention and n = 202 standard care). For the "Efficacy" aspect, there were no differences in proportion exceeding GWG recommendations or mean GWG between groups. Secondary analysis excluding women with gestational diabetes showed that a lower proportion of women in the intervention group had GWG above recommendations (β coefficient 0.51, 95% CI: 0.27 to 0.97; p = 0.04), with less GWG (β coefficient -1.93 kg, 95% CI: -3.63 to -0.24; p = 0.03). For the "Adoption" aspect, qualitative analysis of staff/participants demonstrated strong support for service. For the "Implementation" aspect, strong fidelity (implementation according to study plan) and staff/participant acceptability were observed. Finally, for the "Maintenance" aspect, the program has continued for 4 years with plans/funding for scale-up.
Lifestyle intervention did not alter the overall proportion with excess GWG or total GWG. Secondary analysis, excluding women with gestational diabetes mellitus, showed less GWG. This demonstrates implementation and maintenance of the intervention in routine antenatal care, generating new knowledge within the RE-AIM framework.
本研究的目的是使用“到达、效果、采用、实施和维持”（RE-AIM）框架，评估纳入常规产前护理的生活方式干预措施，以优化孕期体重增加（GWG）及相关结局。
本研究是一项嵌入式实用行为干预研究，由一名健康教练实施，并由一名医生在五节课程中为澳大利亚一家产科服务机构中孕23周以下、孕前体重指数（BMI）在25至43kg/m²之间的女性提供支持。干预组和标准护理组均接受常规产前护理。主要结局是减少孕期体重过度增加的有效性，次要结局是使用RE-AIM框架评估的干预措施的覆盖范围、采用情况、实施情况、维持情况以及母婴结局。
在“覆盖范围”方面，90%的符合条件的女性被纳入研究（N = 404；n = 202为干预组，n = 202为标准护理组）。在“效果”方面，两组中超过GWG建议值的比例或平均GWG没有差异。排除患有妊娠期糖尿病的女性后的二次分析显示，干预组中GWG高于建议值的女性比例较低（β系数0.51，95%置信区间：0.27至0.97；p = 0.04），且GWG增加较少（β系数-1.93kg，95%置信区间：-3.63至-0.24；p = 0.03）。在“采用情况”方面，对工作人员/参与者的定性分析表明对该服务有强烈支持。在“实施情况”方面，观察到高度的保真度（按照研究计划实施）以及工作人员/参与者的可接受性。最后，在“维持情况”方面，该项目已持续4年，并有扩大规模的计划/资金。
生活方式干预并未改变孕期体重过度增加的总体比例或总孕期体重增加量。排除患有妊娠期糖尿病的女性后的二次分析显示孕期体重增加较少。这证明了该干预措施在常规产前护理中的实施和维持情况，在RE-AIM框架内产生了新知识。
