Overview

This trial is active, not recruiting.

Conditions physical activity, obesity
Treatments individual counseling, group counseling, aerobic training
Sponsor University of Sao Paulo General Hospital
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date March 2011
End date April 2012
Trial size 195 participants
Trial identifier NCT01567007, WOMENPED

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(No Intervention)
session of 15-20 minutes duration. It took place guidelines on physical activity, delivering a manual with general information about physical activity
(Experimental)
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.
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.
(Experimental)
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.
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
(Experimental)
The fitness program is held two times per week with individuals and groups with three sessions lasts for 40 minutes performed on a treadmill
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.

Primary Outcomes

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

Eligibility Criteria

Female participants from 40 years up to 50 years old.

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.

Additional Information

Official title Impact of Different Interventions in Physical Activity Level and Co-morbidities in Women: Randomized, Controlled Study
Principal investigator Celso F Carvalho, Phd
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.