Change in Physical Activity Levels in Women at Working Place

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Sao Paulo General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01567007
First received: March 13, 2012
Last updated: March 27, 2012
Last verified: March 2012

March 13, 2012
March 27, 2012
March 2011
April 2012   (final data collection date for primary outcome measure)
Change after 3 and 6 months from Baseline in weekly steps number mean measured by a pedometer [ Time Frame: Change after 3 and 6 months of the baseline evaluation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01567007 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Change in Physical Activity Levels in Women at Working Place
Impact of Different Interventions in Physical Activity Level and Co-morbidities in Women: Randomized, Controlled Study

The purpose of this study is to evaluate the impact of different types of intervention on physical activity level and co-morbidities in women workers aged between 40 and 50 years. Method: A total of 195 sedentary women aged between 40 and 50 years and those who agreed to participate were randomized to one of the following interventions: GI = Control (n = 47), GII = Individual counseling (n = 53), GIII = Counseling group (n = 48); GIV = physical training set (n = 47). Were evaluated: Physical Activity level (steps number evaluated by a pedometer), quality of life (SF-36), body composition (BMI, waist circumference and bioelectrical impedance) and clinical variables (plasma glucose and blood pressure).

Protocols and Randomization of subjects: Subjects were randomized into 4 groups: control group (GI), individual counseling (GII), group counseling (GIII) and aerobic training set (GIV). The protocols of interventions are described in detail below:

GI - Control: Comprising session of 15-20 minutes duration. It took place guidelines on physical activity, delivering a manual with general information about physical activity.

GII - Individual counseling: Consisting of three sessions within a maximum period of 3 months. We conducted a counseling, aimed at increasing physical activity, aiming to raise at least 2000 steps over the first week of monitoring. Furthermore, we discuss the importance of physical activity, such as overcoming barriers to physical activity and targets agreed between the parties. The pedometer is given along with a diary to record the number of steps and returned in the last session.

GIII - Group Counseling: The counseling was conducted in groups (10-12 individuals) for 6 sessions at weekly intervals, and two sessions with fortnightly. Each session lasts 60 minutes. The advice is aimed at behavioral changes using the following approaches: advantages and disadvantages of behavior change, how to overcome barriers to physical activity, self-monitoring of physical activity by using the pedometer and setting goals (number of steps / day) in the short term and what to do in case of relapse (not accomplish what was represented) besides livings practices. As the GII and the goal is to raise steps daily, with the main focus physical activity in leisure time and transport.

GIV - Programmed Aerobic Training: The fitness program is held two times per week with individuals and groups with three sessions lasts for 40 minutes performed on a treadmill.

All interventions lasted between 12 and 15 weeks and were carried out on time or before the commencement of work or during lunch or after work hours.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Physical Activity
  • Obesity
  • Behavioral: individual counseling
    Consisting of three sessions within a maximum period of 3 months. We conducted a counseling, aimed at increasing physical activity, aiming to raise at least 2000 steps over the first week of monitoring. Furthermore, we discuss the importance of physical activity, such as overcoming barriers to physical activity and targets agreed between the parties. The pedometer is given along with a diary to record the number of steps and returned in the last session.
  • Behavioral: group counseling
    The counseling was conducted in groups (10-12 individuals) for 6 sessions at weekly intervals, and two sessions with fortnightly. Each session lasts 60 minutes. The advice is aimed at behavioral changes using the following approaches: advantages and disadvantages of behavior change, how to overcome barriers to physical activity, self-monitoring of physical activity by using the pedometer and setting goals (number of steps / day) in the short term and what to do in case of relapse (not accomplish what was represented) besides livings practices. As the GII and the goal is to raise at least 2000 steps daily on average, with the main focus physical activity in leisure time and transport
  • Behavioral: aerobic training
    The fitness program is held two times per week with individuals and groups with three sessions lasts for 40 minutes performed on a treadmill.
  • No Intervention: control
    session of 15-20 minutes duration. It took place guidelines on physical activity, delivering a manual with general information about physical activity
  • Experimental: Individual counseling
    Consisting of three sessions within a maximum period of 3 months. We conducted a counseling, aimed at increasing physical activity, aiming to raise steps. Furthermore, we discuss the importance of physical activity, such as overcoming barriers to physical activity and targets agreed between the parties. The pedometer is given along with a diary to record the number of steps and returned in the last session.
    Intervention: Behavioral: individual counseling
  • Experimental: group counseling
    The counseling was conducted in groups (10-12 individuals) for 6 sessions at weekly intervals, and two sessions with fortnightly. Each session lasts 60 minutes. The advice is aimed at behavioral changes using the following approaches: advantages and disadvantages of behavior change, how to overcome barriers to physical activity, self-monitoring of physical activity by using the pedometer and setting goals (number of steps / day) in the short term and what to do in case of relapse (not accomplish what was represented) besides livings practices.
    Intervention: Behavioral: group counseling
  • Experimental: aerobic training
    The fitness program is held two times per week with individuals and groups with three sessions lasts for 40 minutes performed on a treadmill
    Intervention: Behavioral: aerobic training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
195
August 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Apparently healthy (no serious chronic disease), sedentary (less than 60 minutes of aerobic physical activity per week scheduled), employees of HC / FMUSP aged between 40 and 50 years.

Exclusion Criteria:

  • Perform some type of pharmacotherapy for weight reduction, have a BMI > 45 kg/m2 and have functional limitations that would prohibit the execution of hiking.
Female
40 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01567007
WOMENPED
Yes
University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Celso F Carvalho, Phd Universidade de São Paulo, Departamento de Fisioterapia Fonoaudiologia e Terapia Ocupacional
University of Sao Paulo General Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP