CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Planet Nutrition programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04095910
NCT04095910N/ACompleted

Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Randomized ControlledTrial

Universidad de Sonora·interventional·Posted Sep 19, 2019·Updated Aug 5, 2020

In Brief

A clinical study evaluating Planet Nutrition program for Childhood Obesity. Completed, enrolled 41 participants across 1 site.

Detailed Summary

Obesity prevention programs in schools are essential to promoting healthy lifestyles. There are programs with positive effects on obesity parameters, but only a few of them have didactic material for its dissemination. In United States they have effective programs (with materials for their implementation) and some are already being implemented in different schools. In Mexico our study group has developed a program called "Planet Nutrition" that includes a manual.The main aim of this study is to evaluate the efficacy of the program "Planet Nutrition"-a nutrition education and behaviour change program- on BMI Z score in school children compared to a control group at 9 weeks. This pilot stud is a randomized controlled trial. The study will be conducted with 41 participants. The primary outcome was the change in the BMI Z score from baseline to 9 weeks. Secondary outcomes were the changes from baseline to 9 weeks in body fat percentage, waist circumference, systolic and diastolic blood pressure, consumption of healthy and unhealthy food, physical activity and sedentary lifestyle, cardiorespiratory capacity and nutrition knowledge. Additionally BMI Z score will be measured at 23 weeks, after the summer vacations. Considering evidence that this period could have a negative impact on children´s weight.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 19, 2019
Enrollment StartMar 18, 2019
Primary CompletionJun 7, 2019
Study CompletionSep 13, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.8 years ago

Interventions

Planet Nutrition programbehavioral

1. \- Nutritional education sessions: The study team previously worked on the development of a handbook called "Planet Nutrition" which contains around 26 topics of nutrition and health. Interns from the Nutritional Sciences Degree of the University of Sonora implemented the sessions. 2 classes of 1 hour were given weekly, adding 18 sessions in total, during regular school hours. The program contemplates the establishment of different objectives. 2. \- Physical activity: The classes were designed and implemented by interns from the Bachelor of Physical Culture and Sport from the University of Sonora along with a teacher from the study team. 3 weekly sessions of 1 hour were provided. The activities were held on the schoolyard court during normal school hours, independent of the physical activity classes of the school. 3. \- Indirect family participation: Six information brochures with different nutrition and health topics were sent to parents.