VAMOS Program at Different Environments of Florianópolis

NCT02823301 | Completed DMC

• 1 other identifier: VAMOS 2016
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the effectiveness and the maintenance of a behavior change program called VAMOS (Active Life Improving Health) Program on physical activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/ Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil, defined according to environmental and income characteristics. Therefore, initially all geographic areas around the HC will be visited to classify the public places as favorable (with the presence of spaces for the practice of PA) and unfavorable environmental (do not have spaces for physical activity). Thereafter, four HC will be selected: high income + high environmental quality index, high income + low environmental quality index, low income + high environmental quality index, low income + low environmental quality index. In each HC, the volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS group and control group. The participants that will be assigned to the VAMOS group will participate in a behavioral change program aimed at motivating changes in physical activity and eating habits during five months (12 meetings - six weekly meetings and six fortnightly meetings), while the control group will receive one educational lecture regarding lifestyle changes. The meetings of VAMOS Program will be held in the dependences or nearby the HC and will be mediated by the physical education professional previously trained. The Program will be evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance. The effectiveness will be assessed from measurements of physical activity, eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid profile before and after five months of intervention. The implementation will be assessed by identifying the extent to which the program will be conducted as planned. The maintenance will be estimated from revaluations of all outcomes, as measured before and after the intervention, six months and one year after the end of the program.

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (2)

• 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, 5 months, 11 months, 17 months

• change in eating habits

  Eating habits will be investigated from the score generated by the food frequency questionnaire, using questions from previous studies (Brasil, 2014; Lopes, 2010). The questionnaire will be applied, using a list of foods for which the average frequency of consumption over the last three months is given.

  baseline, 5 months, 11 months, 17 months

Secondary Outcomes (12)

• change in body mass

  baseline, 5 months, 11 months, 17 months

• change in body mass index

  baseline, 5 months, 11 months, 17 months

• change in waist and hip circumference

  baseline, 5 months, 11 months, 17 months

• change in self-efficacy for physical activity

  baseline, 5 months, 11 months, 17 months

• change in self-efficacy for eating habits

  baseline, 5 months, 11 months, 17 months

Study Arms (2)

VAMOS group

EXPERIMENTAL

Active life improving health: all participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for five months. The VAMOS Program is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by 12 meetings (six weekly meetings and six fortnightly meetings), in group, lasting about 90 min. In each 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.

Behavioral: VAMOS Program

Control group

NO INTERVENTION

Group that will not receive the VAMOS program as intervention.

Interventions

VAMOS Program BEHAVIORAL

Active life improving health: all participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for five months. The VAMOS Program is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by 12 meetings (six weekly meetings and six fortnightly meetings), in group, lasting about 90 min. In each 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.

VAMOS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be registered in the public health system;
• Must have been attended on health center at least one time during the last six months;
• Must be classified as " insufficiently active".

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (1)

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, 88040-900, Brazil

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Tania R Benedetti, doctor

  Federal University of Santa Catarina

  STUDY DIRECTOR

• Cassiano R Rech, doctor

  Federal University of Santa Catarina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

BR (1)