ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- BMI Change
研究概览
简要总结
This is an interventional research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.
详细描述
The purpose of this study is to understand whether the incorporation of social determinants of health into a weight loss/maintenance study, along with a known behavioral intervention will result in improved efficacy than the behavioral intervention by itself. This study will examine the role of psychosocial, clinical, and behavioral factors in the context of the intervention.
The entire duration of the study will be 18 months. Study activities will occur virtually or at YMCA locations in the city of San Francisco or at other community centers.
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)
盲法说明
Due to the nature of lifestyle behavioral intervention, the study design prevents participants and study staff blinding to allocation. However, to minimize bias, outcomes will be assessed by independent study staff blinded to allocation status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants from disadvantaged backgrounds (average median household approximately $31,000 household income/ 4 people,
- •participants in the federal Medicaid insurance program or Medical,
- •age > 18 years old,
- •and BMI > 25 kg/m2 (for Asian ethnicity BMI> 22 kg/m2).
排除标准
- •pregnancy or post-partum state (< 12 months post-partum),
- •history of diabetes (type 1 or 2),
- •history of myocardial infarction, stroke or cardiac arrest in the prior 2 years,
- •history of physician diagnosed cognitive, developmental or psychiatric conditions, recent orthopedic diagnosis or surgery (< 6 months),
- •and persons facing housing eviction or undergoing an active housing leasing process (e.g getting their credit report in shape for a potential lease, in the process of getting a new housing lease).
结局指标
主要结局
BMI Change
时间窗: Baseline and 12 month
Weight will be measured using a calibrated digital scale to the nearest 0.1 kg. Height will be measured using a stadiometer. Waist and hip measurements will be performed using vinyl retractable tape to the nearest 0.1 cm at the smallest horizontal portion of the waist (highest horizontal point of the iliac crest with minimal respiration) and largest area of the hip.
Ideal Cardiovascular Health
时间窗: 12 month and 18 months
AHA 2020 ideal cardiovascular health score will be used as an index about cardiovascular health consisting of health behaviors and factors. Ideal cardiovascular health is defined as: BMI \< 25 kg/m2, \> 150 min/week of moderate physical activity, a healthy diet pattern including sufficient amounts of fruits and vegetables, optimal blood pressure (\< 120/\<80 mmHg), fasting glucose (\< 100 mg/dL), total cholesterol \< 200, and never smoking or quit smoking for more than 12 months For analysis, the investigators will score each item-level category as (0,0.5,1), respectively. This step expands the granularity of ICH Scores from 8 to 15 values, allowing finer measure of longitudinal change during the intervention and maintenance periods. For descriptive purposes,the investigators will compare the later slopes to quantify differential recidivism; within-arm 95% CIs that exclude positive values will demonstrate maintenance of intervention-period weight loss.
BMI Maintenance
时间窗: Baseline and 12 month
The primary analysis of the maintenance phase will include 18-month outcomes, allowing 0-to-12 and 12-to-18 month linear changes by study arm. This model will estimate and compare mean (95% CI) 0-to-18 month changes by study arm: under the hypothesis that differential changes through month 12 will be maintained over the following 6 months, 12- and 18-month differences (95% CI) between arms will be similar (i.e., same sample size calculation). For descriptive purposes, we will compare the later slopes to quantify differential recidivism; within-arm 95% CIs that exclude positive values will demonstrate maintenance of intervention-period weight loss
次要结局
- Impulsivity(Baseline and 12 month)
- Binge Eating(Baseline and 12 month)
- Cellular Aging Biomarkers(Baseline and 12 month)
- Cumulative Stress(Baseline and 12 month)