Evaluating the Feasibility, Health and Behavioral Impact of Mid-Ohio Farmacy + WW
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Attrition rate (Feasibility and Acceptability)
研究概览
简要总结
The aim of this research is to undertake a feasibility study to assess uptake and impact of providing access to a widely available weight management and wellness program (WW; formerly known as Weight Watchers) among individuals experiencing food insecurity and overweight/obesity, who are eligible to receive weekly produce at the Mid-Ohio Food Collective (MOFC) through their pre-existing enrollment in the Mid-Ohio Farmacy program. Participants (n=90) adults over the age of 18 with a BMI between 27-50 kg/m2 will be recruited for a 6 month single-arm clinical trial, where participants will be provided with WW Unlimited Workshop + Digital. The primary objective is to test the feasibility and acceptability of a commercial weight loss and wellness program with an established produce prescription program among individuals experiencing food insecurity and overweight/obesity. Secondary outcomes will include assessments related to weight, height, blood pressure, dietary intake, physical activity, food access, depression, wellbeing and economic factors.
This feasibility study will help inform future interventions among this population. More specifically, this study will help answer questions about the feasibility and acceptability of such an intervention, adherence to the WW program as described to the participant, and the impact that access to a free weight management and wellness program can have on health-related outcomes among individuals experiencing food insecurity and overweight/obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •18 year or older
- •BMI 27-50 kg/m2
- •Positive screen for food insecurity at healthcare provider
- •Enrolled in Mid-Ohio Farmacy (produce prescription program)
- •Speak English
- •Live in greater Columbus,Ohio area for duration of study
- •Reliable internet access
- •Ability to download and install WW app on phone
排除标准
- •Participation in a structured weight loss program in the last 12 months
- •WW membership in the last 12 months
- •Pregnant, nursing or planning to become pregnant
- •Weight loss of 5kg or more in the past 6 months
- •Taking prescription medications for weight loss
结局指标
主要结局
Attrition rate (Feasibility and Acceptability)
时间窗: Up to 8 months
Attrition rate (rate at which patients withdraw from the intervention)
Total number of patients excluded (Feasibility and Acceptability)
时间窗: Up to 8 months
Total number of patients excluded from participation in the intervention
Adherence to study activities (Feasibility and Acceptability)
时间窗: Up to 8 months
Percent of study activities completed by each patient
Participant Satisfaction with the program (Feasibility and Acceptability)
时间窗: Up to 8 months
Participant satisfaction with the intervention (Participant satisfaction questionnaires and semi-structured focus groups)
Food pantry visits (Feasibility and Acceptability)
时间窗: Up to 8 months
Total number of food pantry visits prior to and following enrollment in the intervention
次要结局
- Change in body mass index (BMI) (Clinical Outcomes)(Up to 8 months)
- Change in physical activity (Clinical Outcomes)(Up to 8 months)
- Change in blood pressure (Clinical Outcomes)(Up to 8 months)
- Change in dietary intake (Clinical Outcomes)(Up to 8 months)
- Change in body weight (Clinical Outcomes)(Up to 8 months)
- Change in food security status (SDOH Outcomes)(Up to 8 months)
- Change in economic trade-offs (SDOH Outcomes)(Up to 8 months)
- Change in health related quality of life (SDOH Outcomes)(Up to 8 months)
- Change in well-being (SDOH Outcomes)(Up to 8 months)
- Change in depression (SDOH Outcomes)(Up to 8 months)