Effectiveness of a Program for Physical Activity and Healthy Eating Promotion in Hypertensives

NCT02257268 | Completed

• 1 other identifier: VAMOS REC 01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

health behavior; risk factors;

Outcome Measures

Primary Outcomes (3)

• change in clinic blood pressure

  Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be checked using an automatic oscillometric instrument (Omron HEM 742-E0 - USA). The patients will be instructed to eat a light meal before the measurements, to avoid physical exercise and alcohol ingestion for at least 24 hours prior to the visit, and to avoid smoking and caffeine for at least 12 hours. Measurements will be taken in two non-consecutive days, after 10 minutes of rest in the supine position and three measurements will be done in each day, with one minute interval between measurements. All measurements will be taken on the left arm, in a quiet environment, with monitored temperature.

  baseline, 12 weeks, 24 weeks

• change in physical activity

  Habitual physical activity will be assessed by GT3X or GT3X+ accelerometer (Actigraph - USA) and Actilife 6.10 software will be used to analysis. Each participant will be instructed to use the accelerometer for seven consecutive days, removing it only for sleeping, bathing or performing water activities. The device will be attached to an elastic belt and fixed in the right side of the hip. Data will be collected in a 30 Hz sample frequency and will be analyzed using 60-s epochs. Periods with consecutive values of zero (with 2-min of spike tolerance) for 60 min or longer will be interpreted as "accelerometer not worn" and excluded from the analysis. Physical activity data only will be included if the participant accumulate a minimum of 10 hours/day of recording for at least four days, including one weekend day.

  baseline, 12 weeks, 24 weeks

• change in eating habits

  Eating habits will be investigated from the number of meals daily, quality chewing food, dietary intake concomitantly liquids at mealtimes, habit of eating salads, raw or cooked vegetables, daily water consumption habits and intake of visible fat from meat and chicken. Also, the food frequency questionnaire will be applied, using a list of foods for which the average frequency of consumption over the last three months is given.

  baseline, 12 weeks, 24 weeks

Secondary Outcomes (10)

• change in anthropometric parameters

  baseline, 12 weeks, 24 weeks

• change in body composition

  baseline, 12 weeks, 24 weeks

• change in arterial stiffness

  baseline, 12 weeks, 24 weeks

• change in heart rate variability

  baseline, 12 weeks, 24 weeks

• change in blood flow and flow-mediated dilation

  baseline, 12 weeks, 24 weeks

Study Arms (2)

Change behavior group

EXPERIMENTAL

Change behavior group = Group of change behavior including physical activity and healthy habits promotion.

Behavioral: VAMOS program - Active life improving health

Control group

NO INTERVENTION

Control group = Group that will not receive the VAMOS program as intervention.

Interventions

VAMOS program - Active life improving health BEHAVIORAL

All participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for 12 weeks. VAMOS is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by a weekly meeting, in group, lasting about 90 min. In each weekly meeting, will be discussed guidelines and strategies for physical activities practices in different domains and for adoption of a healthy diet. All aspects and strategies included in the program are based in behavior changes theories. The participants of this group will receive an educational material and, in the middle of the program, they will earn a pedometer to aid in motivation and in the self-monitoring physical activity.

Change behavior group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (1)

Aline Mendes Gerage

Florianópolis, Santa Catarina, 88037-610, Brazil

Location

Related Publications (2)

• 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.

  PMID: 32022106 DERIVED

• 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.

  PMID: 28682707 DERIVED

MeSH Terms

Conditions

Hypertension; Health Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Raphael M Ritti-Dias, Doctor

  University of Pernambuco

  STUDY DIRECTOR

• Tania Rosane B Benedetti, Doctor

  Federal University of Santa Catarina

  STUDY DIRECTOR

• Aline M Gerage, PhD student

  Federal University of Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: September 27, 2014
• First Posted: October 6, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

BR (1)