NCT05635019已完成不适用
Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
研究概览
简要总结
This study is a 3-group, parallel design, randomized controlled trial (RCT) in 105 adults with obesity and food insecurity that will compare BWL-Alone (including standard-of-care referral and connection with community food resources; n=35) to BWL plus food supplementation with either food vouchers (BWL+VOUCHER; n=35) or home-delivered, medically tailored groceries consistent with BWL recommendations (BWL+HOME; n=35). All groups will have BWL treatment provided for 24 weeks per clinical guidelines. Food vouchers and HOME will be provided for 24 weeks of treatment. Assessments will be conducted at baseline, and weeks 12 and 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age >18 years
- •BMI >30 kg/m2 at screening visit
- •Screening positive for food insecurity using a score of >3 on the 10-item US Adult Food Security Survey Module109
- •Completion of baseline assessments
- •Ability to engage in physical activity (i.e., can walk at least 2 blocks)
- •Willing and able to provide pictures of food receipts to study team (or mail actual receipts)
- •Ability to reliably receive packages at a consistent location in a timely manner
- •Telephone or internet service to communicate with study staff
- •For females of reproductive potential: agreement to use of highly effective contraception for during study participation
排除标准
- •Serious medical conditions (e.g., type 1 or type 2 diabetes, renal failure) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
- •Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
- •Breastfeeding, pregnant or planning pregnancy in the next 6 months
- •Planned move from the Philadelphia area in the next 6 months
- •Weight loss of >5 kg in the previous 90 days
- •Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
- •Previous or planned obesity treatment with surgery (excluding lap band if removed for >1 year) or a weight-loss device
- •Use of prescription or over the counter medications for chronic weight management in the past 3 months
- •Household member already participating in study due to potential contamination effects
- •Lack of stable residence and ability to store and prepare food
结局指标
主要结局
Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
时间窗: Change from baseline to 24 weeks
Comparison of BWL+VOUCHER and BWL+HOME vs BWL-Alone in weight change (percent of initial weight) at 24 weeks. Positive numbers represent increases and negative numbers represent decreases.
次要结局
- Percent Change in Total Body Weight at 24 Weeks (BWL+HOME vs BWL+VOUCHER)(Change from baseline to 24 weeks)
- General Health-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)(Change from baseline to 24 weeks)
- Weight-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)(Change from baseline to 24 weeks)
- Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)(Change from baseline to 24 weeks)
- Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)(Change from baseline to 24 weeks)
- General Health-related Quality of Life (BWL+VOUCHER vs BWL+HOME)(Change from baseline to 24 weeks)
- Weight-related Quality of Life (BWL+VOUCHER vs BWL+HOME)(Change from baseline to 24 weeks)
- Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER vs BWL+HOME)(Change from baseline to 24 weeks)
- Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME)(Change from baseline to 24 weeks)
研究者
研究点 (2)
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