NCT02659267

Brief Summary

The study aims to verify if the VAMOS strategy contributes to an increase in physical activity and healthy eating habits among users of the Health Academy Program from Belo Horizonte, Minas Gerais.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

January 11, 2016

Last Update Submit

April 6, 2016

Conditions

Keywords

Health PromotionPhysical ActivityEating habitsHealth SystemUsers from Health Academy Program

Outcome Measures

Primary Outcomes (6)

  • change in physical activity

    Habitual physical activity has been assessed by GT3X or GT3X+ accelerometer (Actigraph - USA) and analysed with Actilife 6.10 software. Each participant was instructed to use the accelerometer on his/her waist for seven consecutive days, removing it only when sleeping, bathing or performing water activities. Attached to an elastic belt, the device had to stay at the right side of the hip. Data are recorded in a 30 Hz sample frequency and analyzed using 60-s epochs. Periods with consecutive values of zero (with 2-min of spike tolerance) for 60 min or longer are interpreted as "accelerometer not worn" and therefore excluded. Physical activity data are included only if the participant got a minimum of 10 hours/day of recording for at least four days, including at least one weekend day

    baseline, 12 weeks, 36 weeks

  • change in frequency of consumption of fresh and minimally processed food

    The frequency of consumption of raw and cooked vegetables, fruits, milk, pulses, meat, fish and tubers / roots has been monitored. The following scores are assigned by means of questionnaire: daily consumption = 4 points; weekly consumption = 3 points, monthly consumption = 2 points; rare consumption= 1 point; null consumption = 0 point. Higher the resulting score, healthier the consumption.

    baseline, 12 weeks, 36 weeks

  • change in Body mass index

    Body mass has been measured while participants wear light clothes and no shoes, using an automatic scale (Welmy - Brazil) to the nearest 0.1 kg. Height has been measured using a stadiometer connected to scale to the nearest 0.5 cm. Body mass index has been calculated as the ratio between body mass in kilograms and the square of height in meters.

    baseline, 12 weeks, 36 weeks

  • change in waist circumference

    Waist circumference is measured at the lesser curvature identified between the last rib and the iliac crest.

    baseline, 12 weeks, 36 weeks

  • change in hip circumference

    Hip circumference is measured in the area of larger diameter of the hip, without compressing the skin.

    baseline, 12 weeks, 36 weeks

  • change in consumption of Ultra-Processed food

    The frequency of consumption of sausages, sandwich cookies, candy, snacks / fatty snacks, soda, juice powder and industrialized seasoning has been monitored. The following scores are assigned by means of questionnaire: daily consumption = 0 points; weekly consumption= 1 point; monthly consumption = 2 points, rare consumption = 3 points; null consumption = 4 points. Higher the resulting score, healthier the consumption.

    baseline, 12 weeks, 36 weeks

Secondary Outcomes (5)

  • change in stages of self-changes for physical activity

    baseline, 12 weeks, 36 weeks

  • change in stages of self-changes for healthy eating habits

    baseline, 12 weeks, 36 weeks

  • change in self-efficacy

    baseline, 12 weeks

  • change in social support

    baseline, 12 weeks

  • change in quality of life

    baseline, 12 weeks, 36 weeks

Study Arms (2)

Interventions Group=

EXPERIMENTAL

Group of change behavior including physical activity and healthy eating habits promotion.

Behavioral: Interventions Group

Control Group=

NO INTERVENTION

Group that will not receive the VAMOS program as intervention, only participate in the Health Academy Program Activities.

Interventions

VAMOS is a lifestyle promotion strategy, designed to promote physical activity and healthy eating habits. The intervention is composed by a weekly meeting, 12-week, in group, lasting about 60 min. In each weekly meeting, were 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 VAMOS strategy are based in behavior changes theories. The participants of this group received educational material and, in the middle of the program, they received a pedometer to aid in motivation and in the self-monitoring physical activity.

Also known as: VAMOS
Interventions Group=

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be user of de Health Academy Program selected for the survey;
  • Must have 20 years or older;

You may not qualify if:

  • Not agree to participated with study;
  • Not agree to sign the written informed consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simone Teresinha Meurer

Belo Horizonte, Minas Gerais, 31310480, Brazil

Location

Related Publications (3)

  • BOFF, R. de M. Evidências Psicométricas das Escalas de Auto-eficácia para regular hábito alimentar e Auto-eficácia para regular exercício físico. Dissertação (mestrado). Pontífica Universidade Católica do Rio Grande do Sul, Porto Alegre, 2012.

    BACKGROUND
  • Reis MS, Reis RS, Hallal PC. Validity and reliability of a physical activity social support assessment scale. Rev Saude Publica. 2011 Apr;45(2):294-301. doi: 10.1590/s0034-89102011000200008. English, Portuguese.

    PMID: 21412569BACKGROUND
  • Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.

    PMID: 10881154BACKGROUND

MeSH Terms

Conditions

Motor ActivityFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Tânia Rosane B Benedetti, Doctor

    Federal University of Santa Catarina

    STUDY DIRECTOR
  • Aline Cristine S Lopes, Doctor

    Federal University of Minas Gerais

    STUDY DIRECTOR
  • Simone T Meurer, PHD Student

    Federal University of Santa Catarina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD student

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 20, 2016

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

March 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations