NCT01567007

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

March 13, 2012

Last Update Submit

March 27, 2012

Conditions

Keywords

pedometerphysical activityworkplace

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

control

NO INTERVENTION

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

Individual counseling

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.

Behavioral: individual counseling

group counseling

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.

Behavioral: group counseling

aerobic training

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

Behavioral: aerobic training

Interventions

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.

Individual 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

group counseling

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

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • Ribeiro MA, Martins MA, Carvalho CR. Interventions to increase physical activity in middle-age women at the workplace: a randomized controlled trial. Med Sci Sports Exerc. 2014;46(5):1008-15. doi: 10.1249/MSS.0000000000000190.

MeSH Terms

Conditions

Motor ActivityObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Celso F Carvalho, Phd

    Universidade de São Paulo, Departamento de Fisioterapia Fonoaudiologia e Terapia Ocupacional

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 30, 2012

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

August 1, 2012

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations