Diabetes in India- Nutrition Guidelines Study (DINGS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 21
- 主要终点
- Hemoglobin A1C decrease
研究概览
简要总结
This study will test the use of the Type 2 Diabetes Mellitus (DM) Evidence Based Nutrition Pratice Guideline (EBNPG) as a tool for dietitians to use with diabetic clients who do not yet have chronic complications and no evidence of organ damage. In addition to comparing the results of care provided using the EBNPG’s to a control group, we will evaluate the magnitude of the differences in current dietitian practice in India from those promoted by EBNPGs. The evaluation will also determine what cultural adaptations to the guides will be necessary while still maintaining the integrity of the intent of the EBNPGs.
xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
This small randomized controlled trial will explore the impact of implementing the Academy of Nutrition and Dietetics (Academy) EBNPGs in India on patient outcome and dietetics practice.
STUDY AIMSPrimary Aim To determine the effect of the dietitian intervention using the type 2 DM EBNPG compared to usual care on client with diabetes health outcomes.
- Compare the change from baseline in nutrition-related health outcomes from clients provided care by dietitians in India following the Academy EBNPG with clients provided “usual care†by dietitians in India at 6 months and 12 months
- Compare the proportion of clients who achieve expected outcomes from clients provided care by dietitian in India following the Academy EBNPG with clients provided “usual care†by dietitians in India
Secondary Aim To determine the usability of Academy’s Type 2 DM EBNPG for Adults and Companion Toolkit for the dietitian intervention by dietitians in India:
a. Evaluate the effect of the dietitian training on dietitians’ knowledge and skills of study protocol procedures and the implementation of the EBNPG, demonstrate fidelity of intervention, and determine the extent to which dietitians implement the EBNPG.
b. Determine if the training provided is appropriate and adequate for the
implementation of Academy EBNPGs
c. Determine what cultural adaptations are needed for implementation in India
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Must be over 19 years of age Must have medical diagnosis for treatment of type 2 Diabetes Mellitus, Patient must agree to return for follow-up visits (or data collection visit) during the 12 months study period Not seen by dietitian for one year prior to being recruited to the study.
排除标准
- •Currently being seen by dietitian for medical nutrition counselling Participated in nutritional consults with dietitian in past year Having insulin prescribed for Diabetes Mellitus treatment at time of recruitment Pregnant or lactating at time of study History of end stage renal disease or renal insufficiency; history of Cardiovascular accident, Coronary artery disease or Myocardial infarction; Chronic obstructive pulmonary disease; Congestive heart failure; untreated depression; severe psychiatric illness; cancer diagnosis in previous two years or on-going radiation or chemotherapy treatment •Unplanned surgery requiring more than one overnight stay in the hospital within the previous week to initial visit •The presence of cognitive or physical limitations that preclude making lifestyle or dietary changes as assessed by the registered dietitian during the initial interview •Unable to return to office for data collection at 6 and 12 months and unable to commit to follow-up visits as per evidence based nutrition practice guidelines and dietitians recommendations.
结局指标
主要结局
Hemoglobin A1C decrease
时间窗: Baseline, 6 months, 12 months
次要结局
- Self Monitoring Data(6 month and 12 month)
- Weight change(6 month and 12 month)
- Lipid Panel(6 Month and 12 month)
- Change in Medications:(Reduction in Diabetes relatedmedications treating hypoglycemia,)