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Clinical Trials/NCT02771821
NCT02771821CompletedNot Applicable

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

Universidade Federal de Pernambuco1 site in 1 country202 target enrollmentStarted: August 1, 2014Last updated:
Conditions
Interventions

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

Experimental

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

No Intervention

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anna Karla de Oliveira Tito Borba

Master

Universidade Federal de Pernambuco

Study Sites (1)

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