跳至主要内容
临床试验/NCT01564797
NCT01564797已完成不适用

Partnership for a Hispanic Diabetes Prevention Program

Fred Hutchinson Cancer Center0 个研究点目标入组 430 人开始时间: 2008年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
430
主要终点
Effect of the intervention on consumption of fresh fruit and vegetables in diabetics and pre-diabetic participants

研究概览

简要总结

The aims of the study are to investigate

  1. the effects of an intervention vs. control on levels of glycosylated haemoglobin (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c at baseline (>6.0%). Glycosylated haemoglobin provides an indication of blood sugar levels over the past 3 months. Elevated hA1c levels are seen in diabetics and pre-diabetics.
  2. the effects of the intervention vs control on consumption of fresh fruit and vegetables
  3. the effects of the intervention vs control on levels of physical activity

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
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

  • •Aged 18 years and older
  • •Haemogloblin A1c ≥ 6.5%
  • •Hispanic Ethnicity

排除标准

  • 未提供

研究组 & 干预措施

Control Arm

No Intervention

A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement)

Education Intervention

Active Comparator

A series of 5 home-based lay health educator-led education sessions (Home Health Parties (HHP)), to educate a Hispanic population about diabetes, management of diabetes, and diet and exercise

干预措施: Home Health Party (Behavioral)

结局指标

主要结局

Effect of the intervention on consumption of fresh fruit and vegetables in diabetics and pre-diabetic participants

时间窗: Baseline, 3 months

Test the efficacy of an intervention to increase the consumption of healthy diets as assessed by increases in fruit and vegetable consumption

Effect of the intervention on physical activity levels in diabetics and pre-diabetic participants

时间窗: Baseline, 3 months

Test the efficacy of an intervention to increase physical activity as assessed by increases in the times per week engaged in strenuous or moderate activity.

Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants

时间窗: Baseline, 3 months

Test the efficacy of an intervention to educate diabetics and pre-diabetics about the management of diabetes as assessed by decreases in hemoglobin A1c;

次要结局

  • Effect of the intervention on changes in knowledge and attitudes about diabetes(Baseline, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

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