Sleep GOALS - An Internet-Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women

睡眠目标 - 针对产后女性的互联网辅助饮食、体力活动和睡眠减肥干预

基本信息

批准号：
10350805
负责人：
MARQUIS S HAWKINS
金额：
$ 17.07万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-15 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10350805
关键词：
Address Age Basic Science Behavior Behavioral Behavioral Sciences Benchmarking Body Weight decreased Cardiovascular Diseases Childbirth Circadian Rhythms Clinical Research Conduct Clinical Trials Control Groups Development Diet Education Effectiveness Elements Energy Intake Ensure Epidemiology Feedback Future Goals Health behavior Heterogeneity Individual Internet Intervention Interview Learning Life Life Style Maternal Health Measures Medicine Morbidity - disease rate National Heart, Lung, and Blood Institute Obesity Overweight Participant Physical activity Postpartum Period Postpartum Women Process Randomized Randomized Controlled Trials Reaction Research Research Personnel Risk Risk Factors Sampling Sleep Sleep Deprivation Sleep Disorders Structure Suggestion Testing Thinking Training Weight Weight Gain Weight maintenance regimen Woman acceptability and feasibility behavior change behavioral health intervention career circadian critical period diabetes prevention program diet and exercise efficacy testing exercise intervention experience feasibility testing group intervention improved innovation intervention mapping lifestyle intervention lipid metabolism mortality multidisciplinary novel novel strategies obesity development online intervention online version perinatal period pilot trial poor sleep post intervention postpartum weight prevent recruit reproductive secondary outcome sleep behavior sleep health sleep onset therapy development treatment strategy user centered design weight loss intervention

项目摘要

Postpartum weight retention (PWR) is a significant contributor to obesity in women of reproductive age. PWR is associated with continued weight gain, obesity development later in life, and cardiovascular disease development (CVD). Among postpartum women, standard weight-loss interventions that address diet and physical activity have produced only modest effects. Prior interventions are limited by not adequately addressing poor sleep, a common issue in postpartum women. Despite epidemiological evidence on the relationship between sleep and obesity, standard weight-loss interventions rarely include key elements of sleep interventions. Integrating sleep interventions with diet and physical activity may enhance weight loss among postpartum women. The overall goal of this K01 is to develop and test the feasibility, acceptability, and preliminary efficacy of Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet-assisted multiple health behavior (diet, physical activity, and sleep) weight loss intervention for postpartum women. We will create Sleep GOALS by adapting and integrating an existing sleep intervention (TSC; Transdiagnostic Sleep and Circadian intervention) with a diet and physical activity weight-loss intervention (GOALS Lifestyles, an online version of the Diabetes Prevention Program). We will use intervention mapping to guide the 3-step adaptation process. First, we will conduct semi-structured interviews with a purposive sample of 12 primiparous women between 3 and 6 months postpartum with overweight or obesity to review the framework and content of TSC and GOALS Lifestyle to solicit their suggestions for adapting these interventions for postpartum women. Step 2: We will pre-test the intervention content by reviewing the proposed adaptations with the same participants. Step 3: We will use feedback from the participants and experts in behavioral sleep medicine, weight loss interventions, and behavior change to ensure the adaptations maintain the core elements of the original interventions and address the specific needs of postpartum women. (Aim 1). We will then randomize 40 postpartum women to Sleep GOALS or an education control group to test the feasibility, acceptability, and preliminary efficacy of Sleep GOALS (Aim 2). We will use the pilot trial results to inform the conduct of a larger and definitive randomized controlled trial. A multi-disciplinary team of experts will guide my training in 1) intervention development, to learn the science of behavioral change, frameworks for intervention development and adaptation, and principles of user-centered design; 2) behavioral sleep medicine, to learn to evaluate sleep problems and developing individual sleep management plans; and 3) randomized controlled trials to learn the best practices of conducting clinical trials research. Consistent with the NHLBI’s Strategic Goals and Objectives, this training will allow me to become an independent researcher who develops/adapts behavioral health interventions that target multiple health behaviors to reduce CVD risk in women during the postpartum period.

产后保留（PWR）是繁殖年龄女性肥胖的重要贡献。 PWR 与持续体重增加，肥胖后期发展以及心血管疾病有关开发（CVD）。在产后妇女中，标准减肥干预措施可以解决饮食和体育活动仅产生适度的影响。事先干预措施受到不适当的限制解决睡眠不佳，这是产后妇女的常见问题。尽管流行病学证据表明睡眠与肥胖之间的关系，标准减肥干预措施很少包括睡眠的关键要素干预措施。将睡眠干预与饮食和体育锻炼相结合可能会增强体重减轻产后妇女。该K01的总体目标是发展和测试可行性，可接受性和睡眠目标的初步效率（以目标为重点的在线访问生活方式支持），一个由互联网辅助产后妇女的多重健康行为（饮食，体育锻炼和睡眠）减肥干预措施。我们将通过适应和整合现有的睡眠干预（TSC；转诊性睡眠）来创造睡眠目标饮食和体育活动减轻干预措施（目标生活方式，一种糖尿病预防计划的在线版本。我们将使用干预映射指导三步适应过程。首先，我们将使用12个实用样本进行半结构化访谈产后3到6个月的自初级女性超重或肥胖症来审查框架以及TSC和目标生活方式的内容，以征求他们对这些干预措施调整的建议产后妇女。步骤2：我们将通过审查提议的改编来预测试干预内容与同一参与者。步骤3：我们将使用参与者和行为睡眠专家的反馈医学，减肥干预措施和行为改变，以确保适应维持核心原始干预措施的要素并满足产后妇女的特定需求。（目标1）。我们将然后将40名产后妇女随机用于睡眠目标或一个教育对照组，以测试可行性，可接受性和睡眠目标的初步效率（AIM 2）。我们将使用试点试验结果通知进行较大且确定的随机对照试验的行为。多学科专家团队将指导我在1）干预开发中的培训，学习行为改变科学，框架干预开发和适应以及以用户为中心的设计原理； 2）行为睡眠医学，学习评估睡眠问题并制定个人睡眠管理计划； 3）随机对照试验以学习进行临床试验研究的最佳实践。持续的有了NHLBI的战略目标和目标，这项培训将使我成为独立的开发/适应行为健康干预措施的研究人员，以减少多种健康行为产后妇女的CVD风险。