Nudging, Healthy Diet and Physical Activity
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|ClinicalTrials.gov Identifier: NCT03136016|
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: educational activities Behavioral: nudging Behavioral: nudging + educational activities||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Design of a School Randomized Trial for Nudging Students Towards Healthy Diet and Physical Activity|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||November 15, 2017|
|Actual Study Completion Date :||December 15, 2017|
No Intervention: control
without any activity
Experimental: educational activities
The students will receive educational activities in the classroom.
Behavioral: educational activities
Group 2 will receive classroom-based educational activities based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans
The students will receive changes in the school environment (nudge strategies);
In group 3, changes in the environment will be included that will facilitate both physical activity and healthy food choices
Experimental: nudging + educational activities
The students will receive educational activities and changes in the school environment.
Behavioral: nudging + educational activities
Group 4 will receive both interventions
- Body Mass Index [ Time Frame: 6 months ]Sample size of PAAPPAS Nudge was calculated based on a minimum effect of 0.15 in BMI variation and considering intra and intergroup comparisons. Body mass index (BMI) will be determined as a ratio between body weight (kg) and squared height (m).
- Fruit consumption [ Time Frame: 6 months ]Food intake will be assessed by a food frequency questionnaire validated for teenagers in Rio de Janeiro and one 24-hour recall (Rec24h). Netbooks containing a computer program developed for school use, based on a technique called "Multiple Pass Method" will be used.
- Vegetable consumption [ Time Frame: 6 months ]Vegetable consumption will be assessed by one 24-hour recall (Rec24h). The food items in the Rec24h will be transformed into daily consumption and grouped according to similary in nutritional containing
- Water consumption [ Time Frame: 6 months ]Water consumption will be assessed by a question regarding the number of glasses of water consumed during a day. Glasses of water consumed during a day will be assessed by a question at baseline and at the end of the study.
- Physical activity [ Time Frame: 6 months ]Physical activity levels will be measured through a validated questionnaire including six questions about frequency and time of different physical activities domains.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136016
|10 Schools of Metropolitan Area|
|Duque de Caxias, Rio De Janeiro, Brazil|