NCT02228447

Brief Summary

The purpose of this study is to evaluate the impact of a multicomponent school-based intervention based on Bandura's Social Cognitive Theory targeting healthy eating and physical activity for high school adolescent girls from low-income communities in the city of São Paulo, Brazil.

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
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 3, 2014

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

August 25, 2014

Last Update Submit

August 29, 2014

Conditions

OverweightObesity

Keywords

AdolescentRandomized controlled trialEating behaviorPhysical ActivitySedentary lifestyle

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    Weight will be measured to the nearest 0.1kg without shoes, in light clothes using a portable digital scale and height was recorded to the nearest 0.1cm using a portable stadiometer. BMI was calculated using the standard equation (weight \[kg\]/height \[m2\]) and BMI z-score was calculated using the "LMS" method

    1 year

Secondary Outcomes (6)

  • Dietary intake

    1 year

  • Physical activity level

    1 year

  • Sedentary behaviors

    1 year

  • Physical activity social-cognitive mediators

    1 year

  • Dietary social cognitive mediators

    1 year

  • +1 more secondary outcomes

Study Arms (2)

No intervention group

NO INTERVENTION

The control group will not receive any intervention during the one year of this study. Only the baseline, 6-12 months assessments (anthropometrics, PA, dietary intake, social cognitive mediators and sedentary behaviors). To prevent compensatory rivalry and resentful demoralization, the control school will be provided with a condensed version of the following 12-month assessments. The condensed version of the program will include the professional learning workshops for intervention schools and the intervention materials (i.e., nutrition and PA handbooks and PA leadership handbook).

Healthy habits, healthy girls group

EXPERIMENTAL

The intervention group will receive a 6-month multicomponent intervention (i.e., enhanced physical education classes; interactive seminars; nutrition workshops; text messages; and parents newsletters) and materials (i.e., nutrition and PA handbooks; cooking books; Choreographies CDs and PA leadership handbook).

Behavioral: Healthy Habits, Healthy Girls Group

Interventions

Healthy Habits, Healthy Girls GroupBEHAVIORAL

The intervention group will receive a 6-month multicomponent intervention (i.e., enhanced physical education classes; interactive seminars; nutrition workshops; text messages; and parents newsletters) and materials (i.e., nutrition and PA handbooks; cooking books; Choreographies CDs and PA leadership handbook).

Healthy habits, healthy girls group

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Adolescent girls from low-income backgrounds enrolled in high schools of the city of São Paulo, Brazil.

You may not qualify if:

  • Adolescent boys
  • Adolescents from middle and high income backgrounds
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health, University of São Paulo

São Paulo, São Paulo, 01246-904, Brazil

RECRUITING

MeSH Terms

Conditions

OverweightObesityFeeding BehaviorMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Sonia Tucunduva Philippi, PhD

    School of Public Health University of São Paulo

    STUDY CHAIR

  • Ana Carolina Barco Leme, Master

    School of Public Health, University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Carolina Leme, Master

CONTACT

+551130617872leme.acarolina@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 29, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

February 1, 2015

Last Updated

September 3, 2014

Record last verified: 2014-08

Locations

BR(1)