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Promoting Healthy Habits With Elderlies Diabetics

Primary Purpose

Diabetes Mellitus, Type 2, Aged, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Operative groups based on methodology of problematization
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of Pernambuco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group Intervention

Control Group

Arm Description

Individual routine consultation with the Family Health Unit team and participation in operative groups based on methodology of problematization

Individual routine consultation with the Family Health Unit team

Outcomes

Primary Outcome Measures

Diabetes Knowledge
Minimum score of 8 points in Diabetes Knowledge Scale (DKN-A) between the baseline and 6 months
Attitude for self-care in diabetes
Count minimum of 70 points in the attitude questionnaire about diabetes (ATT-19) between the baseline and 6 months
Healthy food consumption
Score larger 100 points indicating a feeding good quality through the Healthy Eating Index between the baseline and 6 months
Physical Activity
Greater physical activity than 150 min/week in the International Physical Activity Questionnaire (IPAQ) between the baseline and 6 months
Glycated Hemoglobin
Decrease in glycated hemoglobin levels verified by blood dosage based in change of at least 0.8% between the baseline and 6 months

Secondary Outcome Measures

Body mass index
Reduction of body mass index between the baseline and 6 months
Waist Circumference
Reduction of waist circumference between the baseline and 6 months

Full Information

First Posted
May 7, 2016
Last Updated
May 10, 2016
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02771821
Brief Title
Promoting Healthy Habits With Elderlies Diabetics
Official Title
Promoting Healthy Habits With Elderlies Diabetics: Evaluation of Operative Groups as Therapeutic Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: sociodemographic (T0) - Baseline; Knowledge about diabetes (T0 and T6) assessed by the Diabetes Knowledge Scale (DKN-A); Attitude for self-care (T0 and T6) measured by the ATT-19 - Baseline and Follow-up; healthy food consumption (T0 and T6) assessed by the Healthy Eating Index (HEI) - Baseline and Follow-up; Physical activity (T0 and T6) measured by the International Physical Activity Questionnaire (IPAQ) - Baseline and Follow-up; Anthropometric (T0 to T6) by weight measurement, height, waist circumference and body mass index - Baseline three months and follow-up; Biochemical assessment (T0, T3 and T6) by measuring glycated hemoglobin (A1C) - baseline, three months and follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Aged, Health Behavior, Group Processes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Intervention
Arm Type
Experimental
Arm Description
Individual routine consultation with the Family Health Unit team and participation in operative groups based on methodology of problematization
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Individual routine consultation with the Family Health Unit team
Intervention Type
Other
Intervention Name(s)
Operative groups based on methodology of problematization
Intervention Description
The educational intervention based on the methodology of problematization consisted of the survey prior knowledge on the subject; planning; Implementation and Evaluation through verbalization solutions applicable to the reality of the elderlies. Each operative group was composed of an average of 12 to 15 elderlies diabetics who participated in monthly activities lasting 2 hours, for six consecutive months.
Primary Outcome Measure Information:
Title
Diabetes Knowledge
Description
Minimum score of 8 points in Diabetes Knowledge Scale (DKN-A) between the baseline and 6 months
Time Frame
Six months
Title
Attitude for self-care in diabetes
Description
Count minimum of 70 points in the attitude questionnaire about diabetes (ATT-19) between the baseline and 6 months
Time Frame
Six months
Title
Healthy food consumption
Description
Score larger 100 points indicating a feeding good quality through the Healthy Eating Index between the baseline and 6 months
Time Frame
Six months
Title
Physical Activity
Description
Greater physical activity than 150 min/week in the International Physical Activity Questionnaire (IPAQ) between the baseline and 6 months
Time Frame
Six months
Title
Glycated Hemoglobin
Description
Decrease in glycated hemoglobin levels verified by blood dosage based in change of at least 0.8% between the baseline and 6 months
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Body mass index
Description
Reduction of body mass index between the baseline and 6 months
Time Frame
Six months
Title
Waist Circumference
Description
Reduction of waist circumference between the baseline and 6 months
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Federal University of Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Freire P. Educação como prática de liberdade. 34ª ed. Rio de Janeiro: Paz e Terra; 2011
Results Reference
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Promoting Healthy Habits With Elderlies Diabetics

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