Healthy Habits, Healthy Girls Preventing Unhealthy Weight Gain

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02228447
• Other study ID #: FSP_14
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2014
• Last updated: August 29, 2014
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2014
• Source: University of Sao Paulo
• Contact: Ana Carolina Leme, Master
• Phone: +551130617872
• Email: leme.acarolina[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: February 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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).

Locations

Country	Name	City	State
Brazil	School of Public Health, University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes