Promoting Healthy Habits With Elderlies Diabetics: Evaluation of Operative Groups as Therapeutic Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- Attitude for self-care in diabetes
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Elderlies people with diabetes mellitus diagnosis recorded in the medical record in the Family Health Units, located in the city of Recife, Northeast Brazil
Exclusion Criteria
- •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
Arms & Interventions
Group Intervention
Individual routine consultation with the Family Health Unit team and participation in operative groups based on methodology of problematization
Intervention: Operative groups based on methodology of problematization (Other)
Control Group
Individual routine consultation with the Family Health Unit team
Outcomes
Primary Outcomes
Attitude for self-care in diabetes
Time Frame: Six months
Count minimum of 70 points in the attitude questionnaire about diabetes (ATT-19) between the baseline and 6 months
Physical Activity
Time Frame: Six months
Greater physical activity than 150 min/week in the International Physical Activity Questionnaire (IPAQ) between the baseline and 6 months
Diabetes Knowledge
Time Frame: Six months
Minimum score of 8 points in Diabetes Knowledge Scale (DKN-A) between the baseline and 6 months
Glycated Hemoglobin
Time Frame: 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
Time Frame: Six months
Score larger 100 points indicating a feeding good quality through the Healthy Eating Index between the baseline and 6 months
Secondary Outcomes
- Body mass index(Six months)
- Waist Circumference(Six months)
Investigators
Anna Karla de Oliveira Tito Borba
Master
Universidade Federal de Pernambuco
