NCT05888454Unknown不适用
Dando Pasos Juntos: An Integrative Group Program for Type 2 Diabetes Mellitus
TecSalud Investigación Clínica4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年7月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- HbA1c levels (%)
研究概览
简要总结
This is an open, randomized, controlled trial to determine the impact of an integrative group program on metabolic control and wellbeing perception of patients with T2DM. The integrative group program consists of 6 in-person sessions directed by a health coach and occurring every other week, and 6 asynchronous educative sessions during a period of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM diagnosis of less than 5 years
- •Age 18 to 80 years
- •Current residence in Nuevo León, México
- •Availability to attend in-person sessions
- •Provides written informed consent
- •Able to read and write
排除标准
- •Currently under insulin treatment
- •T2DM diagnosis more than 5 years ago
- •Comorbidities such as active cancer, acquired immunodeficiency (HIV+, AIDS), liver, cardiovascular, renal, pulmonary or thyroid disease.
- •History of severe neurologic or psychiatric disease (current or past diagnosis)
- •Currently pregnant or intention of pregnancy in the following 3 months
- •Males that consume more than 4 alcoholic beverages daily or 14 weekly
- •Females that consume more than 3 alcoholic beverages daily or 7 weekly
- •Consumption of any illicit drug
研究组 & 干预措施
Experimental Group
Experimental
Conventional treatment for T2DM + Integrative Group Program
干预措施: Integrative Group Program (Other)
Experimental Group
Experimental
Conventional treatment for T2DM + Integrative Group Program
干预措施: Conventional treatment for T2DM (Other)
Control Group
Active Comparator
Conventional treatment for T2DM
干预措施: Conventional treatment for T2DM (Other)
结局指标
主要结局
HbA1c levels (%)
时间窗: Baseline to 12 weeks
次要结局
- Fasting insulin (mU/mL)(Baseline to 12 weeks and 36 weeks)
- High-sensitivity C-reactive protein (hs-CRP, mg/dL)(Baseline to 12 weeks and 36 weeks)
- HbA1c levels (%)(Baseline to 12 weeks and 36 weeks)
- Fasting glucose (mg/dL)(Baseline to 12 weeks and 36 weeks)
- Change in lifestyle instrument(Baseline to 12 weeks and 36 weeks)
- Homeostatic Model Assessment (HOMA index)(Baseline to 12 weeks and 36 weeks)
- Subjective sense of wellbeing instrument(Baseline to 12 weeks and 36 weeks)
- Adherence to pharmacological interventions for T2DM(Baseline to 12 weeks and 36 weeks)
- Change in dose of pharmacological interventions for T2DM(Baseline to 12 weeks and 36 weeks)
研究者
研究点 (4)
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