Koa Family: A Study of Improving Diet, Physical Activity, Weight, and Well-being Among Low-income Mothers in California
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index (kg/m2)
研究概览
简要总结
The purpose of this study is to learn if a new whole-person lifestyle program improves the health of low-income mothers.
详细描述
This study will employ a randomized controlled trial (RCT) design to test a newly developed obesity reduction program, Koa Family, among overweight or obese mothers. An exploratory, uncontrolled study will assess its acceptance among normal-weight mothers.
Koa Family consists of a 6-month whole-person lifestyle program (WPLP) combined with text messaging and social media support and the opportunity to take part in a neighborhood tree planting campaign. This multi-pronged program is intended to reduce weight in the short-term while building self-empowerment and connections to community resources so that participants can sustain long-term weight loss.
Koa Family will be implemented in select communities in Yolo and Sacramento counties, California. Overweight or obese study participants will be randomized to either an intervention or control group; all normal-weight participants will be assigned to the intervention. All participants will complete a survey and have their height and weight measured at baseline and 3-, 6-, 9- and 12-month follow-up. Intervention participants will also take part in a focus group at the 3-month midpoint of the intervention.
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
- 18 Years 至 47 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Comfortable speaking and reading English
- •Primary caregiver for ≥1 child, aged 3-17, who lives at home
- •Living in a low-income household (at or below 185% of the Federal Poverty Level)
- •Living in the study site catchment area
- •Ability to receive and send text messages
- •BMI ≥ 25 kg/m2 for RCT study
- •BMI ≥18.5 and <25 kg/m2 for exploratory study
排除标准
- •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 from study site catchment area during the one-year study period
结局指标
主要结局
Change in Body Mass Index (kg/m2)
时间窗: 12 months
Objectively measured
次要结局
- Change in health-related quality of life(12 months)
- Cost effectiveness(12 months)
- Change in physical activity(12 months)
- Change in diet quality(12 months)