- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02771821
Promoting Healthy Habits With Elderlies Diabetics
Promoting Healthy Habits With Elderlies Diabetics: Evaluation of Operative Groups as Therapeutic Intervention
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50670-901
- Federal University of Pernambuco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Intervention
Individual routine consultation with the Family Health Unit team and participation in operative groups based on methodology of problematization
|
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. |
No Intervention: Control Group
Individual routine consultation with the Family Health Unit team
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes Knowledge
Time Frame: Six months
|
Minimum score of 8 points in Diabetes Knowledge Scale (DKN-A) between the baseline and 6 months
|
Six months
|
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
|
Six 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
|
Six 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
|
Six 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
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index
Time Frame: Six months
|
Reduction of body mass index between the baseline and 6 months
|
Six months
|
Waist Circumference
Time Frame: Six months
|
Reduction of waist circumference between the baseline and 6 months
|
Six months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Freire P. Educação como prática de liberdade. 34ª ed. Rio de Janeiro: Paz e Terra; 2011
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAEE - 123965413.0.0000.5208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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