Healthy Habits, Healthy Girls Preventing Unhealthy Weight Gain

NCT ID: NCT02228447

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-02-28

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.

Detailed Description

The "Healthy Habits, Healthy Girls" is a 6-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes: (1) enhanced physical education classes (2x/week and delivered by a Physical Education teacher), (2) break/lunch-time physical activity sessions (the participating girls will encourage younger girls to make Physical Activity during break and/or lunch-time. This session will only happen after 3 months of enhanced Physical Education classes, so the girls will be able to pass their knowledge for the others), (3) Nutrition and Physical Activity handbooks with 10 health messages (lessons to be done at home and their family); (4) 4 Parent newsletters; (5) Food and Physical Activity diaries for self-monitoring; (6) text-messages using a group application for more interaction and social support; and (7) 10 weekly Nutrition and Physical Activity key messages (delivered by a Nutrition and Dietetics Bachelor degree and/or Physical Education teacher during break). The intervention will be evaluated using a randomised controlled trial in 10 public schools in the city of São Paulo, Brazil (5 control and 5 intervention) and based on the 10 weekly key messages: (1) eat fruit and vegetables daily; (2) Do Physical Activity respecting your limits; (3) Eat a healthy breakfast every day; (4) Do Physical Activity with your family and friends; (5) Control the portion size you eat during meals - and sit while you are eating; (6) Reduce your sitting time during school break, after the school period and on the weekends; (7) Have less "junk food" for meals/snacks and munch less; (8) Identify the excuses for not practicing PA; (9) Drink water and substitute sodas and artificial juices for water, homemade natural fruit juices and coconut water, and; (10)Make family meals.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

No intervention group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy habits, healthy girls group

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).

Group Type: EXPERIMENTAL

Healthy Habits, Healthy Girls Group

Intervention Type: BEHAVIORAL

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).

Interventions

Healthy Habits, Healthy Girls Group

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Sonia Tucunduva Philippi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia Tucunduva Philippi, PhD

Role: STUDY_CHAIR

School of Public Health University of São Paulo

Ana Carolina Barco Leme, Master

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, University of São Paulo

Locations

School of Public Health, University of São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Ana Carolina Leme, Master

Role: CONTACT

leme.acarolina@usp.br

+551130617872

Facility Contacts

Sonia Tucunduva Philippi, PhD

Role: primary

philippi@usp.br

+551130617872

Ana Barco Leme, Master

Role: backup

leme.acarolina@usp.br

+5511981859721

Other Identifiers

FSP_14

Identifier Type: -

Identifier Source: org_study_id