ClockWork: Harnessing the Circadian Timing System for Postpartum Weight Management & Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Changes in the "ART" (amount, regularity, and timing of targeted intervention behaviors) from baseline to 4 months postpartum
研究概览
简要总结
The ClockWork Postpartum Weight Management Pilot Study is an intervention study that will assess the feasibility, acceptability, and initial efficacy of the ClockWork intervention among women with prepregnancy overweight/obesity during the first 4 months postpartum.
详细描述
Overview of Procedures. The investigators developed a prototype mobile app to monitor ClockWork target behaviors, and now aim to gain stakeholder input to refine the interface and improve usability via feedback from postpartum women who began pregnancy with obesity. In this pilot trial, women will complete baseline assessments in the first month postpartum and be randomized to either usual care or ClockWork for 4 months, then complete assessments.
Participants & Recruitment. Given that the investigators want to initiate treatment quickly after delivery, women will be recruited at the end of pregnancy through Magee-Womens Hospital. Women will be randomized to receive either the ClockWork intervention or Usual Care. ClockWork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. It addresses 4 key behaviors related to the circadian timing system (CTS), weight, and health and their Amount, Regularity & Timing-the ART of ClockWork. Women will receive 12 tailored coaching sessions to review digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women's needs postpartum. Coaches (Dr. Kolko Conlon or study interventionist) will use women's baseline responses to tailor sessions around the key behaviors. The investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions. Usual Care does not involve any additional intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Prenatal BMI greater than or equal to 25
- •At least 28 weeks gestation
- •English speaking
- •Singleton pregnancy
排除标准
- •Preexisting diabetes
- •Use of medications known to affect weight (example, second generation antipsychotics)
- •Enrolled in current weight management programming
- •Recent weight loss surgery (within the past 3 years)
- •Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
研究组 & 干预措施
ClockWork
Participants who are randomized to treatment will receive the ClockWork intervention
干预措施: ClockWork (Behavioral)
Usual Care
Participants will receive usual care during the postpartum period.
干预措施: Usual Care (Other)
结局指标
主要结局
Changes in the "ART" (amount, regularity, and timing of targeted intervention behaviors) from baseline to 4 months postpartum
时间窗: First 4 months postpartum
A composite score will be calculated to assess changes in the "ART" of behaviors. Participants will record the "ART" of targeted intervention behaviors using self-monitoring forms designed for the study.
Weight change from delivery to 4 months postpartum
时间窗: First 4 months postpartum
Weight in lbs.
Participant liking of ClockWork (sessions, content, digital monitoring interface)
时间窗: First 4 months postpartum
Participant liking will be assessed using a Program Evaluation measure designed for this study. The measure uses a 10-point Likert Scale ranging from "not at all" (1) to "a lot" (10). Higher scores on this measure indicate greater satisfaction with ClockWork program components.
Number of sessions attended among women randomized to receive the ClockWork Intervention
时间窗: First 4 months postpartum
Number of sessions attended will be calculated for each participant
The percentage of days with completed monitoring among women randomized to receive the ClockWork Intervention
时间窗: First 4 months postpartum
Women will be asked to monitor daily
Perceived utility ratings of ClockWork (sessions, content, digital monitoring interface)
时间窗: First 4 months postpartum
Perceived utility will be assessed using a Program Evaluation measure designed for this study. The measure uses a 10-point Likert Scale ranging from "not helpful at all" (1) to "extremely helpful" (10). Higher scores on this measure indicate greater satisfaction with ClockWork program components.
Weight change from prepregnancy to 4 months postpartum
时间窗: Pre-pregnancy through 4 months postpartum
Weight in lbs.
次要结局
未报告次要终点
研究者
Rachel Kolko
Research Assistant Professor
University of Pittsburgh