Change in Physical Activity Levels in Women at Working Place

Obesity Clinical Trial

Official title:

Impact of Different Interventions in Physical Activity Level and Co-morbidities in Women: Randomized, Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01567007
• Other study ID #: WOMENPED
• Status: Active, not recruiting
• Phase: N/A
• First received: March 13, 2012
• Last updated: March 27, 2012
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 195
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity
• Physical Activity

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change after 3 and 6 months from Baseline in weekly steps number mean measured by a pedometer		Change after 3 and 6 months of the baseline evaluation	Yes