NCT03823898

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
15.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

January 27, 2019

Last Update Submit

February 25, 2019

Conditions

ObesityWeight LossLifestyle, SedentaryPhysical ActivityNutritional and Metabolic DiseaseBehavior, HealthCardiovascular Risk Factor

Keywords

obesitybody compositionweight managementcardiovascular and metabolic markersBehavioral changeExercise

Outcome Measures

Primary Outcomes (4)

  • Body weight

    A scale (Seca, Hamburg, Germany) was used to assess body weight

    0 months

  • Body weight

    A scale (Seca, Hamburg, Germany) was used to assess body weight

    4 months

  • Body weight

    A scale (Seca, Hamburg, Germany) was used to assess body weight

    16 months

  • Body weight

    A scale (Seca, Hamburg, Germany) was used to assess body weight

    22 months

Secondary Outcomes (93)

  • Body height

    0 months

  • total and regional fat and fat-free mass

    0 months

  • total and regional fat and fat-free mass

    4 months

  • total and regional fat and fat-free mass

    16 months

  • Thigh Adipose Tissue

    0 months

  • +88 more secondary outcomes

Study Arms (3)

Supervised exercise

EXPERIMENTAL

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.

Behavioral: Supervised exerciseBehavioral: Lifestyle intervention from baseline to 4 monthsBehavioral: Monthly behavioral sessions

Control Group

ACTIVE COMPARATOR

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

Behavioral: Lifestyle intervention from baseline to 4 months

Monthly behavioral sessions

EXPERIMENTAL

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

Behavioral: Lifestyle intervention from baseline to 4 monthsBehavioral: Monthly behavioral sessions

Interventions

Supervised exerciseBEHAVIORAL

Two supervised exercise sessions per week from months 4 to 16

Supervised exercise
Lifestyle intervention from baseline to 4 monthsBEHAVIORAL

Lifestyle intervention from baseline to 4 months

Control GroupMonthly behavioral sessionsSupervised exercise
Monthly behavioral sessionsBEHAVIORAL

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

Monthly behavioral sessionsSupervised exercise

Eligibility Criteria

Age24 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Motricidade Humana

Oeiras, Cruz-Quebrada, 1409-002, Portugal

Location

MeSH Terms

Conditions

ObesityWeight LossSedentary BehaviorMotor ActivityMetabolic DiseasesHealth Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Luís B Sardinha, PhD

    Faculdade Motricidade Humana

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor are masked
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A clinical trial with three-arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 27, 2019

First Posted

January 31, 2019

Study Start

January 2, 2002

Primary Completion

July 1, 2003

Study Completion

December 1, 2003

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

No plans for IPD

Locations

PT(1)