NCT07271940进行中（未招募）不适用
Full Plate Living Nutrition Education Program
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Participant Weight
研究概览
简要总结
The purpose of the research is to evaluate the acceptability and feasibility of implementing a 8-session nutritional education program in a general internal medicine clinic. This program emphasizes a fiber-rich, whole foods diet consisting of fruits, vegetables, legumes, whole grains, nuts and seeds. Such interventions can improve diabetes management and lead to weight loss. 48 participants will be enrolled and on study for approximately 5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-diabetes or diabetes
- •Body Mass Index (BMI) 30-42
- •UW Health Primary Care Physician
排除标准
- •Active cancer (treatment within one year or planning on having treatment)
- •Eating Disorder (SDE Screening 2+)
- •Chronic Kidney Disease (CKD) (Stage 4 or 5)
- •Patient Health Questionnaire-9 (PHQ9) indicating severe depression (greater than 15)
- •No PHQ9 and PHQ2 greater than 2
- •General Anxiety Disorder-7 (GAD7) indicating severe anxiety (greater than 15)
- •No GAD 7 and GAD2 greater than 2
- •Inflammatory bowel disease (IBD)
- •Irritable bowel syndrome (IBS)
- •Readiness to Change less than 7
- •Confidence to Change less than 7
- •Lack of transportation
- •Non-English Speaking
- •No control over food environment
- •No access to laptop, desktop computer, or tablet
- •No email or text message access
- •Unwilling to participate in a shared medical visit
- •Unable to attend one of the four concurrent shared medical visit session cohorts
- •For those on insulin, no access to finger-prick blood glucose meter or continuous glucose monitor
研究组 & 干预措施
Full Plate Living Nutrition Education Program
Experimental
干预措施: Full Plate Living Nutrition Education Program (Other)
结局指标
主要结局
Participant Weight
时间窗: retrospectively from 2 years prior to enrollment and up to 20 weeks on study (3 month follow up)
次要结局
- Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)(baseline, 8 weeks, 20 weeks (3 month follow up))
- Participant Quality of Life measured by the SF-12 score(baseline, 8 weeks, 20 weeks (3 month follow up))
- Acceptability: Percent of Participants who found the intervention acceptable(Participant surveyed at the end of last session, approximately 8 weeks)
- Feasibility: Participant Retention Rate(baseline, 8 weeks, 20 weeks (3 month follow up))
- Feasibility: Participation Rate(Through enrollment (up to 3 months))
研究者
研究点 (1)
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