Koa Family Study--A Community-Based Intervention to Improve Health and Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from Baseline Health-Related Well-being at 4 Months
研究概览
简要总结
Wholehearted living touches every aspect of life, from eating nourishing foods, to enjoying enough physical activity, to cultivating relationships that support healthy choices, to joining with neighbors to stand up for positive changes, and more. Unfortunately, for many low-income Californians, the idea of wholehearted living is an aspiration and not a reality. Koa Family: Strong, Healthy, Whole is an approach designed to make wholehearted living available for all.
The Approach Koa Family is a 4-month journey to establish "micro-communities" of women supporting one another- mind, body, and spirit. The foundation of this approach is a new, custom-designed, online Whole Health Program (WHP) that addresses healthy eating, physical activity, and weight management within the context of wholehearted living. Low-income women and a lifestyle coach will meet weekly in a virtual platform to learn, experience, grow, and thrive as they reach their diet, physical activity, and weight management goals.
Participants in the WHP will receive additional encouragement and access to local resources through a private and secure Facebook group. The group will provide a place for women to continue their wholehearted health journeys beyond the weekly meetings. Koa Family participants also will be invited to take part in a neighborhood tree planting campaign to create real, long-lasting, healthy changes to the environment in which they live.
The Study Koa Family, with WHP at its core, is the product of extensive formative research both nationally and within low-income California communities. Koa Family will be introduced in Sacramento County in February 2021. It will be evaluated for effectiveness among 120 low-income, Supplemental Nutrition Assistance Program (SNAP)-Ed eligible women using a randomized controlled trial study design, the gold standard for assessing effectiveness of an intervention. Outcomes include changes in Body Mass Index, diet, and physical activity measured at 4 and 6 months from baseline. An economic analysis will assess the cost-effectiveness of Koa Family, while qualitative methods will identify mediating factors related to the study outcomes.
Funding Koa Family is a project of the Population Health Group at the University of California, Davis, Center for Healthcare Policy and Research. Funding is provided by the United States Department of Agriculture Supplemental Nutrition Assistance Program-Education and the California Department of Forestry and Fire Protection (CalFIRE).
详细描述
The Koa Family Study is a randomized controlled trial testing a 17-week intervention, the Koa Family Program (KFP), consisting of three components: (1) the Whole Health Program (WHP)-a weekly, online group session facilitated by a health coach using the Zoom platform; (2) social media support including texting of health messages and a private Facebook group; and (3) a community empowerment arm designed around tree planting. The KFP addresses well-being from physical, mental, and social health perspectives. The program is intended to increase weight loss while fostering self-empowerment and connections to community resources to help sustain long-term weight management.
This study will test the following hypotheses:
- Intervention participants, consisting of low-income overweight or obese women living in urban communities, receiving the KFP will have greater average weight loss and reduction in body mass index (BMI) than participants in the control group (who do not participate in the KFP);
- KFP participants will show greater improvements in dietary practices compared with participants in the control group;
- KFP participants will have greater increases in physical activity compared with control group participants;
- KFP participants will have greater improvements in measures of well-being) compared with control group participants;
- There will be a dose-response effect where greater engagement with the components of the KFP will be associated with larger improvements in the above endpoints (weight, diet, physical activity, and well-being).
Study design. The primary study will employ a prospective, randomized controlled trial (RCT) design. One hundred twenty eligible participants will be assigned to either the intervention (n=60) or control (n=60) group.
Intervention. The intervention group (n=60) will participate in the 17-week, KFP that supports physical, mental, and social well-being. It consists of: (1) theWHP-a weekly, online group session facilitated by a health coach using the Zoom platform; (2) social media support including texting of health messages and a private Facebook group; and (3) a community empowerment arm designed around tree planting.
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
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •21-45 years old
- •comfortable speaking and reading English (all race/ethnicities are welcomed to participate)
- •living in a low-income household (at or below 185% of the Federal Poverty Level)
- •living in the Sacramento area
- •familiarity with Facebook, Zoom, and texting
- •access to a smartphone or high-speed internet (via a tablet or computer)
- •overweight or obese (BMI≥25 and <39.9)
排除标准
- •pregnancy;
- •breastfeeding;
- •within 2 years postpartum;
- •life-threatening illness;
- •institutionalization (i.e., not free-living in the community);
- •moderate to severe mental illness;
- •receiving nutrition therapy from a health or health care provider (licensed or unlicensed);
- •had or are considering bariatric surgery;
- •medically diagnosed eating disorder;
- •taking medication that affects weight;
- •thyroid disease;
- •Type 1 or Type 2 diabetes without medical clearance from the participant's physician;
- •plans to move away during the study period.
结局指标
主要结局
Change from Baseline Health-Related Well-being at 4 Months
时间窗: Difference in health-related well-being between baseline and 4 months
Well-being and general health measured with Short Form-36v2; There are 8 sections each scored 0-100 with a high score indicating less disability
Change from Baseline Diet at 4 Months
时间窗: Difference in diet between baseline and 4 months
Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Change from Baseline Body Mass Index (BMI) at 4 Months
时间窗: Difference in BMI between baseline and 4 months
weight (kg)/height (m) x height (m)
Change from Baseline Health-Related Well-being at 6 Months
时间窗: Difference in health-related well-being between baseline and 6 months
Well-being and general health measured with Short Form-36v2
Change from Baseline Body Mass Index (BMI) at 6 Months
时间窗: Difference in BMI between baseline and 6 months
weight (kg)/height (m) x height (m)
Change from Baseline Physical Activity (PA) at 4 Months
时间窗: Difference in PA between baseline and 4 months
Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Change from Baseline Weight at 4 Months
时间窗: Difference in weight between baseline and 4 months
Weight (kg) measured with an electronic scale
Change from Baseline Weight at 6 Months
时间窗: Difference in weight between baseline and 6 months
Weight (kg) measured with an electronic scale
Change from Baseline Physical Activity (PA) at 6 Months
时间窗: Difference in PA between baseline and 6 months
Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Change from Baseline Diet at 6 Months
时间窗: Difference in diet between baseline and 6 months
Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
次要结局
未报告次要终点