背景:有妊娠期糖尿病(GDM)病史的女性在分娩后4-6年发生2型糖尿病(T2D)的可能性是没有GDM的女性的12倍。同样,GDM与常见精神障碍(CMD)(例如焦虑和抑郁)的发展有关。证据表明,关注身体活动(PA)的整体生活方式干预,饮食摄入量,睡眠,心理健康策略可以预防T2D和CMD。这项研究旨在评估新加坡社区环境中GDM后女性的整体生活方式移动健康干预(mHealth)在预防T2D和CMD方面的有效性。
方法:本研究由一项为期1年的随机对照试验(RCT)和3年的随访期组成。目前没有糖尿病诊断且不打算怀孕的GDM后妇女将有资格参加该研究。此外,参与者将完成心理健康问卷(例如抑郁症,焦虑,睡眠)和他们孩子的社会情感和认知发展。参与者将被随机分为第1组(干预)或第2组(比较)。干预组将收到“LVLUP应用程序”,基于智能手机的,对话代理提供的整体生活方式干预侧重于三个支柱:移动更多(PA),吃得好(饮食),减少压力(心理健康)。干预包括健康素养和心理教育辅导课程,每日“生活黑客”(健康活动建议),慢节奏的呼吸练习,步伐跟踪器(包括轻快的步骤),一份低负担的食物日记,和一个日志工具。两组妇女都将获得Oura戒指,用于跟踪身体活动,睡眠,和心率变异性(压力的代理),和“快乐应用程序”,提供有关PA的健康促进信息的mHealth应用程序,饮食,睡眠,和精神健康,以及显示体重指数,血压,和口服葡萄糖耐量试验的结果。短期综合影响将在26/27周(中点)和1年访问时进行评估,接下来是2年、3年和4年的随访期。
结论:GDM后女性T2D和CMD的高进展率表明迫切需要促进健康的生活方式,包括饮食,PA,睡眠,和心理健康。通过整体的预防性干预措施,健康的生活方式可能是解决方案,考虑到身心健康之间的千丝万缕的关系。我们期望整体生活方式mHealth可以有效地支持有GDM病史的女性的行为改变,以预防T2D和CMD。
方法:方案研究得到了新加坡国家医疗集团的批准,特定领域审查委员会(DSRB)[2023/00178];2023年6月。2023年10月18日开始招聘。
背景:ClinicalTrials.govNCT05949957。首次提交日期为2023年6月8日。
BACKGROUND: Women with a history of gestational diabetes mellitus (GDM) are 12-fold more likely to develop type 2 diabetes (T2D) 4-6 years after delivery than women without GDM. Similarly, GDM is associated with the development of common mental disorders (CMDs) (e.g. anxiety and depression). Evidence shows that holistic lifestyle interventions focusing on physical activity (PA), dietary intake, sleep, and mental well-being strategies can prevent T2D and CMDs. This
study aims to assess the effectiveness of a holistic lifestyle mobile health intervention (mHealth) with post-GDM women in preventing T2D and CMDs in a community setting in Singapore.
METHODS: The
study consists of a 1-year randomised controlled
trial (RCT) with a 3-year follow-up period. Post-GDM women with no current diabetes diagnosis and not planning to become pregnant will be eligible for the
study. In addition, participants will complete mental well-being questionnaires (e.g. depression, anxiety, sleep) and their child\'s socio-emotional and cognitive development. The participants will be randomised to either Group 1 (Intervention) or Group 2 (comparison). The intervention group will receive the \"LVL UP App\", a smartphone-based, conversational agent-delivered holistic lifestyle intervention focused on three pillars: Move More (PA), Eat Well (Diet), and Stress Less (mental wellbeing). The intervention consists of health literacy and psychoeducational coaching sessions, daily \"Life Hacks\" (healthy activity suggestions), slow-paced breathing exercises, a step tracker (including brisk steps), a low-burden food diary, and a journaling tool. Women from both groups will be provided with an Oura ring for tracking physical activity, sleep, and heart rate variability (a proxy for stress), and the \"HAPPY App\", a mHealth app which provides health promotion information about PA, diet, sleep, and mental wellbeing, as well as display body mass index, blood pressure, and results from the oral glucose tolerance tests. Short-term aggregate effects will be assessed at 26/27 weeks (midpoint) and a 1-year visit, followed by a 2, 3, and 4-year follow-up period.
CONCLUSIONS: High rates of progression of T2D and CMDs in women with post-GDM suggest an urgent need to promote a healthy lifestyle, including diet, PA, sleep, and mental well-being. Preventive interventions through a holistic, healthy lifestyle may be the solution, considering the inextricable relationship between physical and psychological health. We expect that holistic lifestyle mHealth may effectively support behavioural changes among women with a history of GDM to prevent T2D and CMDs.
METHODS: The protocol
study was approved by the National Healthcare Group in Singapore, Domain Specific Review Board (DSRB) [2023/00178]; June 2023. Recruitment began on October 18, 2023.
BACKGROUND: ClinicalTrials.gov NCT05949957. The first submission date is June 08, 2023.