Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School

• ClinicalTrials.gov Identifier: NCT02034994
• Recruitment Status: Completed
• First Posted: January 14, 2014
• Last Update Posted: September 19, 2019
• Sponsor: Rio de Janeiro State University
• Collaborator: Universidade Federal do Rio de Janeiro
• Information provided by (Responsible Party): Rosely Sichieri, Rio de Janeiro State University

Tracking Information

• First Submitted Date: January 10, 2014
• First Posted Date: January 14, 2014
• Last Update Posted Date: September 19, 2019
• Actual Study Start Date: February 15, 2014
• Actual Primary Completion Date: November 15, 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 10, 2014): Body Mass Index [ Time Frame: One Year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 10, 2014): Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean [ Time Frame: One year ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 10, 2014)

• Sedentary activities [ Time Frame: One year ]
• Sugar sweetened beverages intake [ Time Frame: one year ]
• cookies intake [ Time Frame: one year ]
• fruits intake [ Time Frame: one year ]
• physical activity [ Time Frame: one year ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
• Official Title: Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
• Brief Summary: The main objective is to evaluate the effects of a multicomponent, school-based intervention combining change in nutritional behaviors with after school physical activity activities in reducing the excessive weight gain in schoolchildren.

Detailed Description

Specific objectives are:

- evaluate the effect of the program on: change in nutritional behaviors, such as reducing sugar sweetened beverages and cookies intake reduction of time spent in sedentary activities gains in school performance and cognition outcomes the amount of daily physical activity on the percentage of body fat, changes in biochemical markers and blood pressure.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Obesity

Intervention

Behavioral: Eating behavior and physical activity change

A combination of two prevention school based programs will be addressed to schoolchildren over one year. Primary prevention will be developed monthly in order to reduce cookies and sugar sweetened beverages consumption, reduction of sedentary activities, increase meal consumption frequency and quality etc, in all children from 6th and 7th grades. Overweight and obese children will be invited to participate on a secondary prevention program in which daily physical activity classes will be performed by physical education teachers in school facilities.

Study Arms

• Experimental: Intervention group
  Reduction of sugar sweetened beverages. cookies, sedentary activities and increasing physical activity
  Intervention: Behavioral: Eating behavior and physical activity change
• No Intervention: Control group
  No intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 10, 2014): 1200
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 15, 2014
• Actual Primary Completion Date: November 15, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Both prevention programs:

• 6th and 7th grades students
• consent form signed by parents / tutors

Secondary prevention program:

- overweight and obese children

Exclusion Criteria:

• pregnant girls

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 9 Years to 15 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT02034994
• Other Study ID Numbers: IMS-PAPPAS2-project
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Rosely Sichieri, Rio de Janeiro State University
• Study Sponsor: Rio de Janeiro State University
• Collaborators: Universidade Federal do Rio de Janeiro
• Investigators: Not Provided
• PRS Account: Rio de Janeiro State University
• Verification Date: September 2019