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临床试验/NCT02771821
NCT02771821已完成不适用

Promoting Healthy Habits With Elderlies Diabetics: Evaluation of Operative Groups as Therapeutic Intervention

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
2
主要终点
Attitude for self-care in diabetes

研究概览

简要总结

Randomized clinical trial with the objective of evaluating the effectiveness of operative groups to promote healthy habits in elderlies diabetics. The study was conducted in the Family Health Units of Microregion 4.2 Sanitary District IV of Recife, Pernambuco, Northeast Brazil. Participated in 202 elderlies diabetic randomly assigned to two groups: intervention and control, with similar characteristics in relation to age. Data collection occurred from August 2014 to August 2015 and elderlies were followed for 6 months (T0 to T6). Control group participated in the routine individual consultation with the staff of the Family Health Unit on a quarterly basis. Intervention group participated the routine individual consultation with the staff of the Family Health Unit on a quarterly basi and six operative groups of health education, with monthly frequency and duration of two hours, using the methodology of problematization (FREIRE, 2011), with themes identified from the needs of the participants.

详细描述

The study was conducted in the Family Health Units Microregion 4.2, Sanitary District IV, located in the city of Recife, Northeast Brazil. For the sample size was considered alpha error 5% (u), beta error of 20% (v). The standard deviation of glycated hemoglobin concentration distribution in both groups (Dp1 and Dp2) was equal to 1.9g/dL, and the difference between the intergroup glycated hemoglobin average was equal to 0.8%.

Initially a survey was conducted of elderlies diabetics interested in participating in the study. Then, an individual randomization of the sample was done using a table of random numbers generated by the software EPI INFO, version 6.04d. Two groups were formed, intervention and control, with similar characteristics in terms of age. Data collection occurred from August 2014 to August 2015 and the elderlies participants in the intervention group or control were followed for 6 months (T0 to T6).

Control Group: 101 elderlies diabetics who participated in the routine individual consultation with the staff of the Family Health Unit on a quarterly basis.

Group Intervention: 101 elderlies diabetics that in addition to individual routine consultation with the staff of the Family Health Unit on a quarterly basis participated in operative groups of health education. The groups had monthly frequency, duration of two hours and were conducted in close community spaces Health Units to facilitate the access of the elderlies.The operative groups with the methodology of problematization (FREIRE, 2011), included issues related to the promotion of healthy habits, identified from the needs of elderlies themselves.

In both groups, intervention and control the variables investigated were:

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)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderlies people with diabetes mellitus diagnosis recorded in the medical record in the Family Health Units, located in the city of Recife, Northeast Brazil

排除标准

  • Live in long-stay institutions
  • Elderly hospitalized
  • Wheelchair users
  • Deficit communication and / or cognition recorded in the chart
  • Presence of chronic complications of diabetes in advanced stages
  • Locomotion difficulty restricting access to health facility

结局指标

主要结局

Attitude for self-care in diabetes

时间窗: Six months

Count minimum of 70 points in the attitude questionnaire about diabetes (ATT-19) between the baseline and 6 months

Physical Activity

时间窗: Six months

Greater physical activity than 150 min/week in the International Physical Activity Questionnaire (IPAQ) between the baseline and 6 months

Diabetes Knowledge

时间窗: Six months

Minimum score of 8 points in Diabetes Knowledge Scale (DKN-A) between the baseline and 6 months

Glycated Hemoglobin

时间窗: Six months

Decrease in glycated hemoglobin levels verified by blood dosage based in change of at least 0.8% between the baseline and 6 months

Healthy food consumption

时间窗: Six months

Score larger 100 points indicating a feeding good quality through the Healthy Eating Index between the baseline and 6 months

次要结局

  • Waist Circumference(Six months)
  • Body mass index(Six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Karla de Oliveira Tito Borba

Master

Universidade Federal de Pernambuco

研究点 (2)

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