Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT02257268
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2014-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Program for Physical Activity and Healthy Eating Promotion in Hypertensives
Sponsor:
Universidade Federal de Santa Catarina
Organization:
Study Overview
Official Title:
Effectiveness of VAMOS - a Change Behavior Program for Physical Activity and Healthy Eating Promotion - in Hypertensives
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to evaluate the effectiveness of VAMOS program, a physical activity and healthy eating promotion program, in hypertensive from Recife-Pernambuco- Brazil. Approximately 90 subjects with a diagnosis of hypertension, under anti-hypertensive medication and classified as non-physically active, will be selected and randomly distributed into two groups: a change behavior group (CBG) and control group (CG). The CBG will participate of a change behavior program, entitled VAMOS - Active Life Improving Health, for 12 weeks and composed of a weekly meeting, in group, lasting about 90 minutes. In each weekly meeting, will be presented and discussed guidelines and strategies for practical physical activities in different fields and for adoption of a healthy diet in order that the level of physical activity and eating quality improve. The program will be evaluated by effectiveness, implementation and maintenance (initial and individual level) dimensions of RE-AIM framework. The effectiveness will be assessed from anthropometric measurements, body composition, eating habits, physical activity level, stages of self-change, self-efficacy, social support, quality of life and assessment of cardiovascular function at rest (clinic and home blood pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart rate variability) before and after 12 weeks of intervention. The implementation will be assessed by identifying the extent to which the program will be conducted as planned. The maintenance, initial and at individual level, will be estimated from revaluations of all outcomes, as measured before and after the intervention, three months after the end of the program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed models wil be applied for for within and between groups comparison, if the premises of this test are met. The level of significance that will be adopted is P\<0.05. All analyzes will be done at SPSS statistical package, version 17.0.
Detailed Description:
The overall goal of this study is to evaluate the effectiveness of VAMOS program, a physical activity and healthy eating promotion program, in hypertensive from Recife-PE- Brazil. As secondaries goals, the study attempts to:
1. evaluate the effectiveness of VAMOS program with regard to physical activity, the sedentary behavior and eating habits in hypertensives;
2. analyze whether self-efficacy, stages of self-change and social support mediate the possible effects of VAMOS program on physical activity, sedentary behavior and eating habits in hypertensives;
3. evaluate the effectiveness of VAMOS program with regard to clinic and home blood pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart rate variability in hypertensives;
4. evaluate the effectiveness of VAMOS program on anthropometric and body composition variables in hypertensives;
5. analyze whether the possible result changes brought from VAMOS program in behavioral and biological variables promote changes in quality of life of hypertensives;
6. assess the implementation of VAMOS program in nonpharmacological treatment of hypertension in Recife, northeastern of Brazil;
7. identify whether the possible effects achieved from VAMOS remain three months after the end of the program in hypertensives.
1. evaluate the effectiveness of VAMOS program with regard to physical activity, the sedentary behavior and eating habits in hypertensives;
2. analyze whether self-efficacy, stages of self-change and social support mediate the possible effects of VAMOS program on physical activity, sedentary behavior and eating habits in hypertensives;
3. evaluate the effectiveness of VAMOS program with regard to clinic and home blood pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart rate variability in hypertensives;
4. evaluate the effectiveness of VAMOS program on anthropometric and body composition variables in hypertensives;
5. analyze whether the possible result changes brought from VAMOS program in behavioral and biological variables promote changes in quality of life of hypertensives;
6. assess the implementation of VAMOS program in nonpharmacological treatment of hypertension in Recife, northeastern of Brazil;
7. identify whether the possible effects achieved from VAMOS remain three months after the end of the program in hypertensives.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: