A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in fruit and vegetable intake from baseline at 20 weeks
研究概览
简要总结
An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers.
详细描述
The pilot study will lead to development of a future, large randomized controlled clinical trial, by fulfilling the following aims:
Pilot Aim 1: Demonstrate feasibility of recruitment and ability to perform study procedures.
Pilot Aim 2: Demonstrate the ability to measure accurately chronic disease risk factors such as diet, physical activity, weight gain, microbiome characteristics and inflammatory biomarkers.
Pilot Aim 3: Provide preliminary results on the efficacy of gardens as a preventive intervention, and estimates for a detailed power analysis for the proposed subsequent larger trial.
Aim 3a: Demonstrate that compared to non-gardeners, gardeners have 1) greater intake of fruits and vegetables; 2) better Healthy Eating Index (HEI); 3) lower Diet Inflammatory Index (DII); 4) reduced sedentary time and increased moderate-to-vigorous physical activity (MVPA); and reduced age-associated weight gain.
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)
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
- •Able to give informed consent in English or Spanish
- •Aged 18 or over
- •Currently on the wait list for a new garden
- •Not have gardened in the past 2 gardening seasons
排除标准
- •Is not able to complete the study requirements in Spanish or English
- •Aged 17 or younger
- •Has gardened in the past 2 gardening seasons
结局指标
主要结局
Change in fruit and vegetable intake from baseline at 20 weeks
时间窗: Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)
6 24-hour diet recalls will be collected at random
Change in moderate-to-vigorous physical activity (MVPA) from baseline at 20 weeks
时间窗: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Accelerometers will be adhered to thigh and collect data for 7 days
Change in waist circumference from baseline at 20 weeks
时间窗: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Objective measurement of waist circumference
Change in taxonomic diversity from baseline at 20 weeks
时间窗: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in relative dominance from baseline at 20 weeks
时间窗: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in sedentary time behavior from baseline at 20 weeks
时间窗: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Accelerometers will be adhered to thigh and collect data for 7 days
Change in Inflammatory biomarkers from baseline at 20 weeks
时间窗: 20 weeks
Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10
Change in bacterial load from baseline at 20 weeks
时间窗: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be collected six time points using 1 gut, 2 skin, and 1 oral samples
Change in weight (kg) from baseline at 20 weeks
时间窗: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Objective measurements of weight will be collected
Change in pathogenic taxa from baseline at 20 weeks
时间窗: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in indicator taxa from baseline at 20 weeks
时间窗: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
次要结局
- Change in blood pressure from baseline at 20 weeks(20 weeks)
- Change in HbA1C from baseline at 20 weeks(20 weeks)
- Change in lipid profile from baseline at 20 weeks(20 weeks)
研究者
Jill Litt
Associate Professor, Environmental Studies
University of Colorado, Boulder