NCT01501721

Brief Summary

Objective: This study aimed to characterize the food intake and energy expenditure of school cooks and to evaluate the anthropometric and metabolic changes that occurred after a low-volume home-based exercise program. Methods: A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was conducted during the school year of 2007. The trial had a factorial design based on two different interventions: 1) nutritional counseling and 2) home-based exercise. The nutritional intervention was focused on decreasing the amount of sugar used in school meals by the cooks as well as decreasing their own sugar intake. The exercise program consisted of stretching and aerobic exercises that could be practiced at home, at least three times per week (40 minutes per session), with a low-to-moderate intensity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4 obesity

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 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

11 months

First QC Date

December 14, 2011

Last Update Submit

December 28, 2011

Conditions

Keywords

preventionworkersclinical trialsobesity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline for weight at 4 and 8 months of follow-up

    Body weight was measured using the same calibrated digital scale (Tanita, BC 533 Inner Scan) for all participants

    Baseline, 4 and 8 months

Study Arms (2)

Exercise

EXPERIMENTAL

Home-based exercise program

Behavioral: Exercise

Nutritional counseling

EXPERIMENTAL

Nutrition counseling aiming to reduce suggar intake

Behavioral: Diet

Interventions

ExerciseBEHAVIORAL

Home-based exercise program

Also known as: Home-based exercise group
Exercise
DietBEHAVIORAL

Nutritional counseling aiming to reduce suggar intake

Also known as: Diet group
Nutritional counseling

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Of the 36 public schools spread over five different areas, we selected 20 schools from three areas with similar demographic and socio-economic profiles.

You may not qualify if:

  • School cooks who were pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Mauro Mediano, PhD

    Rio de Janeiro State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 29, 2011

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

December 29, 2011

Record last verified: 2011-12