Healthy Habits, Healthy Girls Preventing Unhealthy Weight Gain

Healthy Habits, Healthy Girls: a Intervention Program for Adolescent Girls From Disadvantaged Backgrounds

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Healthy Habits, Healthy Girls Group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Carolina Leme, Master; Phone Number: +551130617872; Email: leme.acarolina@usp.br

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-904
    • Recruiting
    • School of Public Health, University of São Paulo
    • Contact: Sonia Tucunduva Philippi, PhD; Phone Number: +551130617872; Email: philippi@usp.br
    • Contact: Ana Barco Leme, Master; Phone Number: +5511981859721; Email: leme.acarolina@usp.br
    • Sub-Investigator: Ana Carolina Barco Leme, Master
    • Principal Investigator: Sonia Tucunduva Philippi, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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).
Experimental: 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).	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake	Dietary intake was assessed a 49-item semi-quantitative food-frequency questionnaire (FFQ) Subjects were asked about their consumption over the previous 12-months. The frequency options ranged from "Never" to "at least twice a day" for all the items.	1 year
Physical activity level	PA was assessed using a brief PA questionnaire that aims to evaluate the PA frequency and intensity realized in one week. The subjects should inform the number of times of light-to-vigorous intensity PA practiced for at least 30 minutes during a period of seven days (i.e., week and weekends).	1 year
Sedentary behaviors	The subjects reported the time spent during the weekdays (Monday through Friday) and weekends (Saturday and Sunday) in the following activities: watching television/videos/DVDs, using the computer for leisure activities (games and social networks), using telephone and studying, reading or doing homework.	1 year
Physical activity social-cognitive mediators	Social cognitive scales for dietary and PA behaviors based on constructs from Social Cognitive Theory were adapted and designed for the study. Participants will complete PA scales for the following constructs: self-efficacy, intentions, family and friends support, environment perceptions (situation), behavioral strategies (self-control), outcome expectations (perceived benefits) and outcome expectancies (valued placed on benefits).	1 year
Dietary social cognitive mediators	Social cognitive scales for dietary behaviors based on constructs from Social Cognitive Theory were adapted and designed for the study. Participants will complete dietary scales for the following constructs: self-efficacy, intentions, family and friends support, environment perceptions (situation), behavioral strategies (self-control), outcome expectations (perceived benefits) and outcome expectancies (valued placed on benefits)	1 year
Waist circunference	waist circumference will be measured to the nearest 0.1cm against the skin using a non-extensible steel tape in line with the umbilicus.	1 year

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Sonia Tucunduva Philippi, PhD, School of Public Health University of São Paulo; Principal Investigator: Ana Carolina Barco Leme, Master, School of Public Health, University of São Paulo

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: August 29, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Adolescent; Physical Activity; Randomized controlled trial; Sedentary lifestyle; Eating behavior
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: FSP_14