NCT02711488

Brief Summary

The objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable 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

First Submitted

Initial submission to the registry

February 15, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

February 15, 2016

Last Update Submit

September 16, 2019

Conditions

Keywords

school-based interventionsedentary behaviorphysical activitysugar sweetened beverages

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    one year

Secondary Outcomes (1)

  • Body composition

    one year

Other Outcomes (5)

  • adherence to the protocol at household level

    one year

  • physical activity

    one year

  • physical activity

    one year

  • +2 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Combine primary prevention activities at the school level with secondary prevention at the household level

Behavioral: Intervention group

Control group

NO INTERVENTION

No intervention

Interventions

The proposed intervention will focus on encouraging students to change their eating habits and food consumption over 9 months (from March to November). Monthly 1-h sessions in the classroom will be given by the class teacher, and includes playing games, staging theater sketches, watching movies and puppet shows, and writing and drawing contests. The activities were designed to discourage students from consuming sugar-sweetened beverages as well as getting them to replace snacks, particularly processed foods (especially cookies) with fresh fruit or healthy homemade food. To reinforce the messages of the in-class nutritional sessions, a set of messages will be sent to the families in the form of illustrated booklets and recipes. The secondary prevention strategy at households will be developed for those with excessive weight. The family will receive additional motivation to change these behaviors, using the community health agents as the encourager.

Intervention group

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both prevention programs
  • th and 6th grades students
  • consent form signed by parents/tutors
  • Secondary prevention program
  • Overweight and obese children

You may not qualify if:

  • pregnant girls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sgambato MR, Cunha DB, Henriques VT, Estima CC, Souza BS, Pereira RA, Yokoo EM, Paravidino VB, Sichieri R. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention. BMC Public Health. 2016 Aug 17;16(1):809. doi: 10.1186/s12889-016-3473-3.

MeSH Terms

Conditions

ObesitySedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD. Full Professor of Epidemiology

Study Record Dates

First Submitted

February 15, 2016

First Posted

March 17, 2016

Study Start

March 1, 2016

Primary Completion

November 15, 2016

Study Completion

December 1, 2016

Last Updated

September 17, 2019

Record last verified: 2019-09