Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment - Number of the Total Sample
研究概览
简要总结
The overall goal of the study is to develop a novel weight loss intervention for postpartum people by providing strategies to improve sleep, diet, and physical activity behaviors. In this study, we will recruitment and enroll 40 postpartum people and randomize them to receive the Sleep GOALS intervention or education control to evaluate the intervention's feasibility, acceptability, and preliminary efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Stated willingness to comply with all study procedures and availability for the duration of the study,
- •Primiparous, singleton pregnancy,
- •Between 3+1 and 6+1 months postpartum,
- •Has a body mass index >25 kg/m2,
- •Physically inactive, defined as self-reporting <150 minutes/week of moderate-to-vigorous intensity physical activity,
- •Endorse >1 indicator of poor sleep health based on the RU_SATED questionnaire, and
- •Has smartphone and home Internet access
排除标准
- •current use of medications that affect weight,
- •currently pregnant or plan to become pregnant during the study period (18 weeks), and
- •participating in another weight loss intervention.
结局指标
主要结局
Recruitment - Number of the Total Sample
时间窗: Baseline
The number of participants enrolled in 12 months
Engagement - Total Time Logged in
时间窗: Week 1 to 16
Total time logged in during the 16-week intervention
Recruitment - Proportion of Ethnic Minority
时间窗: Baseline
The proportion of ethnic minority participants was calculated as the percentage of participants who did not identify as Non-Hispanic White. For this study, 'Ethnic Minority' includes participants who self-identified as: (1) Hispanic or Latino (of any race), or (2) Non-Hispanic and any of the following races: American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, or More than One Race.
Retention Rate
时间窗: Post-intervention at week 17
Retention rate is defined as the number of participants who completed the final study visit at week 17, divided by the total number of participants randomized in each arm.
Engagement - Number of Modules Completed
时间窗: Week 1 to 16
The number of modules completed within 16 weeks
Engagement - Number of Self-monitoring of Diet, Sleep and Physical Activity Weekly
时间窗: Week 1 to 16
The number of weeks in which self-monitoring of diet, sleep, and physical activity is performed at least once a week
Engagement - Number of Weekly Weigh-ins
时间窗: Week 1 to 16
The number of weeks in which weigh-in is performed at least once a week
Acceptability - Proportion of Agreeing
时间窗: Assessed weekly from Week 1 to Week 16; average score across all weeks reported.
Acceptability was assessed using a weekly 3-item intervention acceptability questionnaire focused on the participants' experience with the intervention. This outcome specifically reports on three key items: (1) the usefulness of implementing weekly action plans, (2) the clarity of content regarding overcoming barriers or challenges, and (3) the ease of using the intervention platform. Participants rated their level of agreement with statements such as 'The weekly action plans were useful for my behavior change' and 'The materials clearly addressed how to manage barriers.' Each item scored from 1 to 5 (1=Strongly Disagree to 5=Strongly Agree). A higher score represents a higher level of acceptability. Acceptability scores were assessed weekly from Week 1 to Week 16. The value reported represents the average score across all 16 weeks.
次要结局
- Weight Change(Baseline and Post-intervention at week 17)
- Number of Participants With Postpartum Weight Retention >11 Lbs(Post-intervention at week 17)
研究者
Marquis Hawkins
Assistant Professor
University of Pittsburgh