Efficacy of the Application of the Nutrition Care Process on the Eating Habits of Older Adults in the State of Colima During 12 Months of Follow-up: a Randomized, Single-blind Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Changes from baseline Malnutrition parameters measured by GLIM Criteria at 12 months
研究概览
简要总结
The aim of this clinical trial is to determine the efficacy at 12 months of the application of the nutrition care process in the eating habits of older adults in the state of Colima, Mexico compared to a conventional nutritional intervention.
The main questions it aims to answer is: what is the efficacy of the application of the nutrition care process vs. a conventional nutritional intervention on the eating habits of older adults in the state of Colima, Mexico after 12 months of follow-up?
详细描述
Participants will be two study groups. Group 1 will apply the nutritional care process and Group 2 will use standard care. The Structured Survey of Food Quality of the older adult will be applied to classify eating habits as good and bad; as well as the reduction of malnutrition in the study participants, in addition, the 24-hour reminder and the food consumption frequency questionnaire will be evaluated before and after the nutritional intervention, an eating plan will be determined according to the needs and later, follow-up will be given for 8 weeks, finally monitoring will be done at 3, 6 and 12 months in order to detect changes in eating habits.
The financial resources will be financed by resources own in the Social Coexistence Center for the older adults in the metropolitan area of Colima, Mexico. Group experience: there are health professionals specialized in patient care.
The protocol has the approval of a local research ethics committee (CEICANCL220223-NUTRICIA-02).
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
- Single (Participant)
盲法说明
Each participant belonging to this institution has the same probability of being selected for the study. On this occasion, a numbered list of the subjects candidates to participate in the study will be needed. Subsequently, by means of a raffle with balls numbered from 1 to 2, the subjects will be assigned to each of the interventions, number 1 corresponds to the intervention with the nutrition care process and number 2 to the conventional nutritional intervention.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older adults ≥ 60 years old
- •female or male
- •who voluntarily agree to participate in the study.
排除标准
- •People who have a specific treatment determined by another health professional
- •people with chronic kidney disease and hemodialysis or dialysis treatment.
- •adherence less than 80% in the nutritional intervention
- •incomplete data collection, participants who decide to leave the project
- •people who are hospitalized or die.
结局指标
主要结局
Changes from baseline Malnutrition parameters measured by GLIM Criteria at 12 months
时间窗: 12 months after the intervention with the Nutrition Care Process
Application of the Global Leadership Initiative on Malnutrition (GLIM)
Changes from baseline Eating Habits (Survey of Food Quality of the Older Person) at 12 months
时间窗: 12 months after the intervention with the Nutrition Care Process
Application of the structured Survey of Food Quality of the Older Person.
次要结局
- Changes from baseline hypertension control at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline protein intake (by a dietary recall) at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline energy intake (by a dietary recall) at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline obesity control at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline serum total cholesterol at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline Quality of life perception (WHOQOL) at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from lean body mass at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline fat body mass at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline body mass index at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline carbohydrate intake (by a dietary recall) at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline lipid intake (by a dietary recall) at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline water mass at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline diabetes mellitus control at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline serum albumin at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline undernutrition control at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline serum HDL Cholesterol at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline serum triglycerides at 12 months(12 months after the intervention with the Nutrition Care Process)
- Changes from baseline fasting glucose at 12 months(12 months after the intervention with the Nutrition Care Process)
研究者
Miguel Huerta
Professor
Universidad de Colima