Lifestyle Intervention in Overweight Women

NCT ID: NCT03823898

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-02

Study Completion Date

2003-12-01

Brief Summary

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The Exercise and Obesity Health Promotion (PESO) program is a randomized controlled trial designed to analyze the effects of a lifestyle intervention in weight management and health-related parameters of overweight and obese premenopausal women

Detailed Description

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The PESO (Exercise and Obesity Health Promotion Program) is a program of weight control and exercise promotion for overweight and obese premenopausal women, developed by specialists in exercise, nutrition, and psychology, under medical supervision. It is a program that promotes the autonomy of the participants and the permanent modification of their habits and lifestyles, without the use of drugs or any other products, devices, or techniques of "slimming".

Participants in the PESO Program were able to enjoy a regular and multifaceted group program, aiming to increase knowledge about permanent body weight control, increased motivation and practice of physical activity and exercise, and improved habits food and nutrition. Increases in functional mobility, metabolic health, quality of life and the physical and mental well-being of the participants are central priorities of this Program.

The PESO Program was conducted in a university context and was led by teachers and researchers from the Faculty of Human Motors and other national and foreign institutions. The program is not for commercial purposes, it does not entail financial costs for the participants and it is involved in a wide range of scientific research projects, which have been recognized by individuals and external entities as relevant and of interest to the general population and the community in particular.

Conditions

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Obesity Weight Loss Lifestyle, Sedentary Physical Activity Nutritional and Metabolic Disease Behavior, Health Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A clinical trial with three-arm
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor are masked

Study Groups

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Supervised exercise

Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants were involved in two supervised exercise sessions per week plus healthy lifestyle interactive sessions.

The experimental intervention consisted of: a) monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study; b) The supervised exercise sessions were prescribed using an aerobic mode performed at a moderate-to-vigorous intensity during 45 minutes, twice a week, preferably during the weekends.

Group Type EXPERIMENTAL

Supervised exercise

Intervention Type BEHAVIORAL

Two supervised exercise sessions per week from months 4 to 16

Lifestyle intervention from baseline to 4 months

Intervention Type BEHAVIORAL

Lifestyle intervention from baseline to 4 months

Monthly behavioral sessions

Intervention Type BEHAVIORAL

Monthly behavioral sessions consisted of lifestyle interactive sessions will take place monthly and covered and followed contents that were addressed during the first 4 months of the study

Control Group

Participants in this group received a lifestyle intervention from baseline to 4 months. From 4 to 16 months participants received no intervention

Group Type ACTIVE_COMPARATOR

Lifestyle intervention from baseline to 4 months

Intervention Type BEHAVIORAL

Lifestyle intervention from baseline to 4 months

Monthly behavioral sessions

Participants in this group received a lifestyle intervention from baseline to 4 months and then from 4 to 16 months participants were involved in non-supervised exercise group sessions with monthly behavioral sessions.

The experimental intervention consisted of monthly behavioral sessions consisted of lifestyle interactive sessions took place monthly and covered and followed contents that were addressed during the first 4 months of the study

Group Type EXPERIMENTAL

Lifestyle intervention from baseline to 4 months

Intervention Type BEHAVIORAL

Lifestyle intervention from baseline to 4 months

Monthly behavioral sessions

Intervention Type BEHAVIORAL

Monthly behavioral sessions consisted of lifestyle interactive sessions will take place monthly and covered and followed contents that were addressed during the first 4 months of the study

Interventions

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Supervised exercise

Two supervised exercise sessions per week from months 4 to 16

Intervention Type BEHAVIORAL

Lifestyle intervention from baseline to 4 months

Lifestyle intervention from baseline to 4 months

Intervention Type BEHAVIORAL

Monthly behavioral sessions

Monthly behavioral sessions consisted of lifestyle interactive sessions will take place monthly and covered and followed contents that were addressed during the first 4 months of the study

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* older than 24 years,
* be premenopausal and not currently pregnant,
* BMI higher than 24.9 kg/m2,
* free from major disease
Minimum Eligible Age

24 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Faculdade de Motricidade Humana

OTHER

Sponsor Role lead

Responsible Party

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Luís Bettencourt Sardinha

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luís B Sardinha, PhD

Role: STUDY_DIRECTOR

Faculdade Motricidade Humana

Locations

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Faculdade de Motricidade Humana

Oeiras, Cruz-Quebrada, Portugal

Site Status

Countries

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Portugal

Other Identifiers

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PESO-2002

Identifier Type: -

Identifier Source: org_study_id

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