Clinical trial NCT02257268: Effectiveness of a Program for Physical Activity and Healthy Eating Promotion in Hypertensives
Official title: Effectiveness of VAMOS - a Change Behavior Program for Physical Activity and Healthy Eating Promotion - in Hypertensives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: health behavior; risk factors;
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertension;
* Must be under anti-hypertensive medications for three months or more;
* May not present diabetes or other cardiovascular diseases;
* May not be engaged in regular physical activity;
* May not have physical disabilities that compromise the physical activity practices.

Exclusion Criteria:

* Not agree to participated with study;
* Not agree to sign the written informed consent;
* Change in doses or type of anti-hypertensive medications.

Primary outcomes:
measure: change in clinic blood pressure
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in physical activity
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in eating habits
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: change in anthropometric parameters
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in body composition
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in arterial stiffness
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in heart rate variability
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in blood flow and flow-mediated dilation
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in home blood pressure monitoring
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in stages of self-changes
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in self-efficacy
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in social support
timeFrame: baseline, 12 weeks, 24 weeks
measure: change in quality of life
timeFrame: baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Aline Mendes Gerage
state: Santa Catarina
Study officials:
affiliation: University of Pernambuco
name: Raphael M Ritti-Dias, Doctor
role: STUDY_DIRECTOR
affiliation: Federal University of Santa Catarina
name: Tania Rosane B Benedetti, Doctor
role: STUDY_DIRECTOR
affiliation: Federal University of Santa Catarina
name: Aline M Gerage, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerage AM, Benedetti TRB, Cavalcante BR, Farah BQ, Ritti-Dias RM. Efficacy of a behavior change program on cardiovascular parameters in patients with hypertension: a randomized controlled trial. Einstein (Sao Paulo). 2020 Jan 31;18:eAO5227. doi: 10.31744/einstein_journal/2020AO5227. eCollection 2020.
citation: Gerage AM, Benedetti TRB, Ritti-Dias RM, Dos Santos ACO, de Souza BCC, Almeida FA. Effectiveness of a Behavior Change Program on Physical Activity and Eating Habits in Patients With Hypertension: A Randomized Controlled Trial. J Phys Act Health. 2017 Dec 1;14(12):943-952. doi: 10.1123/jpah.2016-0268. Epub 2017 Sep 22.