Glycemic Excursion Minimization (GEM) to Outshine Health Disparities: RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change from baseline on percent time in range from continuous glucose monitor at post-intervention
研究概览
简要总结
The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels, reduce diabetes distress, and increase empowerment and confidence in managing diabetes.
详细描述
The purpose of the study is to test the feasibility, acceptability, and initial efficacy of the tailored GEM intervention among adult Black patients with type 2 diabetes, who are not on insulin or secretagogues.
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
- 否
入选标准
- •type 2 diabetes
- •capable of making dietary and physical activity changes
排除标准
- •on insulin or secretagogue
- •on medications that impede weight loss (e.g., prednisone)
- •pregnant or planning pregnancy in the next 2 months
- •no history of moderate to severe hypoglycemia
研究组 & 干预措施
GEM Intervention
A lifestyle coach will deliver the GEM intervention over 4 weeks in person and/or virtually (synchronously) to permit interaction with participants. A pocket-sized manual will be provided with 4 units corresponding to session topics, and diary pages to record glucose responses to food and physical activity (PA). Session 1: Introduce GEM, identify personal motivation, learn about foods that cause glucose to go high (high glycemic load (GL) foods) and those that do not (low GL foods), learn how physical activity affects glucose, and begin monitoring how these choices affect glucose. Session 2: Replacement, substitution, and portion control to reduce consumption of high GL foods. Session 3: Increasing PA and reducing sedentary behavior, esp. after a meal. Session 4: Ways to continue lifestyle changes over a lifetime, handle relapses, and thank loved ones for their support. Text message reminders may be sent to participants between sessions to prompt diary entries and for encouragement.
干预措施: GEM Intervention (Behavioral)
Waitlist
Participants will be invited to receive the GEM intervention after they posttest, the next time it is offered.
结局指标
主要结局
Change from baseline on percent time in range from continuous glucose monitor at post-intervention
时间窗: Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 weeks
Difference in percent of time in range (70-180 mg/dL) from continuous glucose monitor data. Change = post intervention week minus baseline week.
次要结局
未报告次要终点