A Pilot Randomized Clinical Trial of Walking, Dance, and Abdominal Core Workouts to Improve Adipocytokines Among Insufficiently Active Adults With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Retention Rate in each group
研究概览
简要总结
The phenomenon of physical activity (PA) avoidance in obesity has been detailed in the literature, but there is a lack of programs designed to address the root causes. In addition to common PA barriers such as lack of time, individuals with obesity face weight-related impediments, including stigma, shame, poor fitness, and low exercise self-efficacy, which reduce their engagement in PA. These impediments have been observed in white and minoritized populations. Numerous studies have suggested that individuals with obesity prefer activities that are enjoyable, less exhausting, and conveniently available in settings where they are not exposed to stigma. The studies also point to a need for programs that focus on the general health benefits of PA rather than weight loss, which although desirable, can be elusive.
Unmet weight loss expectations contribute to high dropout rates and non-adherence to the prescribed PA regimen among those with obesity. This is particularly consequential for minoritized populations including African Americans who tend to lose less weight in lifestyle interventions but achieve significant improvements in many cardiometabolic outcomes.
In this proposal, investigators present PA as a buffer against the deleterious effects of obesity, agnostic of weight loss status.
The Physical Activity for The Heart (PATH) program was intentionally designed to provide vicarious experiences for diverse individuals with obesity, by featuring their peers in body size, fitness level, and age engaging in PA.
The impact of the PATH intervention on these biomarkers will provide important insights into the mechanisms via which a combination of popular PA modalities improves cardiometabolic outcomes in the context of obesity.
详细描述
The proposed research is significant because it will provide key evidence supporting the use of curated, openly sourced content to address PA barriers in obesity. Physical Activity for The Heart (PATH) intervention, which is anchored on the social cognitive theory's (SCT) premise that observing similar (i.e. body type, fitness level, age) others succeed can motivate action and help demonstrate a plan for success.
Thus proposal will examine the feasibility of using PATH in a weight-neutral context and the preliminary effects on adipocytokines that influence insulin resistance. If PATH improves PA and adipocytokines, it could provide a highly scalable tool for mitigating the risk of cardiometabolic disease, especially among those looking for weight-agnostic PA programs. The walking, dance, and abdominal core workouts to be examined in this proposal are extremely popular and abundant on YouTube, which makes it easy to access and curate content that can be tailored to individual preferences.
The highly scalable PATH program is accessible at any time in any setting and can lessen the impact of unpredictable barriers to PA such as inclement weather or pandemics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years, body mass index (BMI) ≥30kg/m2,
- •regular access to the Internet,
- •self-monitoring of PA via waist worn Actigraph during run-in (≥4 days with ≥10hrs wear time),
- •self-reported non-adherence to PA Guidelines [<150 min of moderate to vigorous physical activities (MVPA/wk)].
排除标准
- •pregnancy/intention to become pregnant within 12 weeks,
- •involvement in litigation related to a health issue, or a condition that requires supervised PA (e.g., stroke).
- •Individuals with a history of cerebrovascular disease (CVD), type 2 diabetes (T2D),
- •any affirmative response to any question in the Physical Activity Readiness Questionnaire (PAR-Q) will require primary care physician (PCP) clearance before enrollment.
研究组 & 干预措施
PATH Intervention
Insufficiently active adults with obesity will be assigned to the PATH intervention.
干预措施: PATH Intervention (Behavioral)
PATH Intervention
Insufficiently active adults with obesity will be assigned to the PATH intervention.
干预措施: Physical activity tracker (Device)
PATH Intervention
Insufficiently active adults with obesity will be assigned to the PATH intervention.
干预措施: Dietary education (Behavioral)
Control Group
Insufficiently active adults with obesity will be assigned to the attention control group.
干预措施: Control Group (Behavioral)
Control Group
Insufficiently active adults with obesity will be assigned to the attention control group.
干预措施: Physical activity tracker (Device)
Control Group
Insufficiently active adults with obesity will be assigned to the attention control group.
干预措施: Dietary education (Behavioral)
结局指标
主要结局
Retention Rate in each group
时间窗: 12 weeks
Retention rate in each group at 12 weeks after enrollment
Participants' satisfaction of protocol procedures (acceptability)
时间窗: 12 weeks
Satisfaction by participants will be measured with neutral messages/content collected via an end-of-study survey on user experience.
Adherence to protocol procedures
时间窗: 12 weeks
Proportion of the sample who adhere to key study procedures (e.g., regular self-monitoring of PA, attendance of coaching sessions)
Attainment of recruitment goal
时间窗: 4 months after screening procedures start
Percentage of recruitment goal achieved within 4 months
Participants Enrolled Within 4 Months of Study Opening
时间窗: 4 months after screening procedures start
Number of participants enrolled within 4 months after the study opened to enrollment.
Number of Participants Retained in Each Group
时间窗: 12 weeks
Number of participants (Retention rate) retained in each group at 12 weeks after enrollment
The System Usability Scale
时间窗: 12 weeks
The System Usability Scale (SUS) is an industry-standard, 10-item questionnaire used to evaluate the perceived usability of a product, system, or service. It provides a quick, reliable, and quantifiable measure of ease of use and user satisfaction. Users rate their level of agreement or disagreement with 10 statements using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Responses are converted and summed according to standard SUS scoring and transformed to a total score ranging from 0 to 100. The average score is about 68. A score above 68 is considered above average/good; a score below 68 is below average. Acceptability Ranges: Scores above 70 are typically considered "Acceptable," while scores below 50 usually indicate a system with poorer usability that needs to be redesigned.
Participants' Satisfaction of Protocol Procedures (Acceptability)
时间窗: 12 weeks
Participant satisfaction was assessed using an end-of-study user experience survey. Participants rated navigation ease (extremely easy/very easy) and overall satisfaction with the content and messaging. Navigation ease (extremely/very easy) Cultural appropriateness (very/somewhat appropriate) Workout access (extremely/very easy) Text reminders helpful (extremely/very helpful)
Participants' Engagement
时间窗: 12 weeks
Participants who visited the PATH platform at least twice weekly.
次要结局
- Changes in Monocyte Chemoattractant Protein-1 (MCP-1)(Baseline and 12 weeks)
- Changes in T2D risk score(Baseline and 12 weeks)
- Changes in adiponectin and leptin(Baseline and 12 weeks)
- Changes in proinflammatory cytokines(Baseline and 12 weeks)
- Adiponectin and Leptin(Baseline and 12 weeks)
- Monocyte Chemoattractant Protein-1 (MCP-1)(Baseline and 12 weeks)
- Proinflammatory Cytokines(Baseline and 12 weeks)
- Insulin Levels(Baseline and 12 weeks)
- Type 2 Diabetes (T2D) Risk Score(Baseline and 12 weeks)
研究者
Jacob Kariuki
Associate Professor
Emory University