Clinical trial NCT02857127: Physical Activity Promotion in Primary Health Care Settings
Official title: Promoting Physical Activity for Vulnerable Adults and Elderly People: Evaluation of a Walking Program in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Keywords: Low income population
Motor Activity
Primary Health Care
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-08-05
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A quasi experimental study evaluating the effectiveness of a walking program at primary health care settings in a low-income area

Detailed description: There is a high prevalence of physical inactivity (AF) in the world and in Brazil. Offering programs of physical activity becomes a convenient option to increase the physical activity level of the population and promote aging process more active and healthy over the life. There is need for greater depth in relation to the operation of programs to promote physical activity and the effects of these programs on different biopsychosocial aspects, especially those offered in primary care settings. This research aims to evaluate a walking program geared to adults and seniors on the following aspects:

1. Characteristics and operation of the intervention,
2. effects of behavior change to physical activity, and
3. biopsychosocial effects of physical activity.

It is a quasi experimental and controlled study, with: 1) intervention group (n = 71), 2) and control group (n = 71). The intervention will last for six months, with a subsequent follow-up period of six months after the intervention. The program will offer supervised exercise twice a week, lasting an hour. The classes will consist of recreational activities, walking and educational strategies of behavior change for physical activity. Variables will be evaluated for attendance, barriers to physical activity, waiver reasons, physical activity level, sociodemographic, socioeconomic and biopsychosocial aspects. Most females, aged over 40 years, low levels of education, income and varied biopsychosocial characteristics are expected. After the intervention, it is expected that the program present characteristics of low adhesion and retention, especially because of the barrier "lack of time". Still, the promotion of supervised walking increase levels of physical activity beyond the time provided by the program and it will improve the biopsychosocial conditions of the participants.

Eligibility criteria: Inclusion Criteria:

* To be insufficiently active
* To accept the intervention invitation
* Living around the selected primary health care
* To sign the Term os Consent
* To have 18 years or more

Exclusion Criteria:

* To participate only in one day of intervention
* To have less than 75% of presence in the intervention
* To give up of the intervention

Primary outcomes:
measure: Subjective evaluation of physical activity level evaluated through the International Physical Activity Questionnaire
timeFrame: six months
measure: Objective evaluation of physical activity level evaluated through accelerometer device
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Secretaria Municipal de Saúde
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Grace AO Gomes, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baba CT, Oliveira IM, Silva AEF, Vieira LM, Cerri NC, Florindo AA, de Oliveira Gomes GA. Evaluating the impact of a walking program in a disadvantaged area: using the RE-AIM framework by mixed methods. BMC Public Health. 2017 Sep 15;17(1):709. doi: 10.1186/s12889-017-4698-5.