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Transdisciplinary Program Against Childhood Obesity (OTPACO)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transdisciplinary program
Sponsored by
Fortaleza University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Obesity, Children, Health Colective

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • To be eligible for the study, children should

    • be overweight or obese in accordance with the definition given above6,
    • be considered healthy by a physician after undergoing a clinical examination,
    • attend the transdisciplinary intervention sessions once a week (minimum attendance required: 90%)
    • be authorized to participate by their parents or caretakers.
  • The children in the control group were not submitted to the intervention and were not participating in any other program involving obesity control or supervised physical activity.
  • All children (G1+G2) were instructed to maintain their habitual level of physical activity and attend the school's regular physical education classes.
  • The latter were scheduled twice a month during the first term and four times a month during the second.
  • The decision to increase the frequency was made by the school's director in acknowledgment of the importance of physical activity, but the change affected the two groups equally.

Exclusion Criteria:

  • Children were ineligible if they had chronic diseases (defined as diseases requiring continuous therapy), mental disorders or cognitive impairments which might interfere with communication, or used a pacemaker, or declined participation.
  • Children in G1 missing more than 10% of the total intervention sessions were excluded from the sample.

Sites / Locations

  • Carminda Maria Goersch Fontenele Lamboglia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transdisciplinary program

Control group

Arm Description

Children in G1 were submitted to a transdisciplinary intervention once a week. Each child received a nutritional education kit including four games ("Cool Diet", a board game, a memory game and a word search puzzle) and an interactive booklet containing).

The children in the control group (G2) were not exposed to interventions.

Outcomes

Primary Outcome Measures

Height (cm) (outcome)
Body mass (kg) (outcome)
Body mass index (kg/m2) (outcome)
Waist circumference (cm) (outcome)
Waist circunference/height ratio (outcome)
Body fat percentage (%) (outcome)
Fat body mass (kg) (outcome)
Lean body mass (kg) (outcome)
Abdominal strength (repetition) (outcome)
Flexibility (cm) (outcome)

Secondary Outcome Measures

Full Information

First Posted
April 13, 2015
Last Updated
May 20, 2015
Sponsor
Fortaleza University
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1. Study Identification

Unique Protocol Identification Number
NCT02453269
Brief Title
Transdisciplinary Program Against Childhood Obesity
Acronym
OTPACO
Official Title
Outcome of a 1-year Transdisciplinary Program Against Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fortaleza University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate the outcome of a 1-year transdisciplinary program against childhood obesity.
Detailed Description
The study was quasi-experimental with a quantitative approach.5 Epidemiologically, the study may be characterized as a controlled, randomized trial. Twenty participants were selected non-randomly from an elementary school in Fortaleza, Brazil. The parents or caretakers of the participants gave their informed written consent. The 20 participants were distributed randomly into two groups, G1 (intervention, n=10) and G2 (control, n=10). Six children did not complete the study protocol: three in G1 due to insufficient attendance, and three in G2 for unspecified reasons. To be eligible for the study, children should i) be overweight or obese in accordance with the definition given above6, ii) be considered healthy by a physician after undergoing a clinical examination, iii) attend the transdisciplinary intervention sessions once a week (minimum attendance required: 90%) and iv) be authorized to participate by their parents or caretakers. The children in the control group were not submitted to the intervention and were not participating in any other program involving obesity control or supervised physical activity. All children (G1+G2) were instructed to maintain their habitual level of physical activity and attend the school's regular physical education classes. The latter were scheduled twice a month during the first term and four times a month during the second. The decision to increase the frequency was made by the school's director in acknowledgment of the importance of physical activity, but the change affected the two groups equally. Children were ineligible if they had chronic diseases (defined as diseases requiring continuous therapy), mental disorders or cognitive impairments which might interfere with communication, or used a pacemaker, or declined participation. Children in G1 missing more than 10% of the total intervention sessions were excluded from the sample. The study was conducted at an elementary school in Fortaleza, Brazil, maintained by the Edson Queiroz Foundation/UNIFOR. Data were collected at baseline in May 2013 (pre-test) and after one year of intervention, in May 2014 (post-test), as part of the transdisciplinary program against childhood obesity. Children in G1 were submitted to a transdisciplinary intervention once a week. Each child received a nutritional education kit including four games ("Cool Diet", a board game, a memory game and a word search puzzle) and an interactive booklet containing illustrations of foods selected from the participants' cultural context (Northeastern Brazil). The kit was validated by Munguba. The children in the control group (G2) were not exposed to interventions during the study period. They attended the school's regular physical education classes, but were excluded from the sample if they joined any other physical activity or weight control program. At the end of the study, the children in G2 received the booklet described above, including the results of the physical fitness evaluation. Talks about the importance of physical activity and healthy food in this group were scheduled for early 2015. Upon the first visit, all participants were given a physical evaluation (BMI, height and waist circumference) following the procedures standardized by Lohman, Roche and Martorell. The body composition was determined by bioelectrical impedance (Bodystat 1500 MMD) upon the second visit. Upon the first, the children were instructed in how to prepare for the test: abstain from food and drink (4 hours before), exercise (12 hours before), alcohol (24 hours before) and diuretic medication (7 days before), and urinate 30 min before the test. The subject is measured lying down, with electrodes attached to hands and feet. The muscular fitness assessment was based on FitnessGram®, a criterion-referenced test, but was limited to flexibility and abdominal muscle strength/endurance. The evaluation of sexual maturity was based on the age at menarche in girls and on armpit hair development in boys. The purpose of this evaluation was to identify each participant's stage of growth, development and maturity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Obesity, Children, Health Colective

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transdisciplinary program
Arm Type
Experimental
Arm Description
Children in G1 were submitted to a transdisciplinary intervention once a week. Each child received a nutritional education kit including four games ("Cool Diet", a board game, a memory game and a word search puzzle) and an interactive booklet containing).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The children in the control group (G2) were not exposed to interventions.
Intervention Type
Behavioral
Intervention Name(s)
Transdisciplinary program
Primary Outcome Measure Information:
Title
Height (cm) (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Body mass (kg) (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Body mass index (kg/m2) (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Waist circumference (cm) (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Waist circunference/height ratio (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Body fat percentage (%) (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Fat body mass (kg) (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Lean body mass (kg) (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Abdominal strength (repetition) (outcome)
Time Frame
Participants were followed for the duration of one year
Title
Flexibility (cm) (outcome)
Time Frame
Participants were followed for the duration of one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be eligible for the study, children should be overweight or obese in accordance with the definition given above6, be considered healthy by a physician after undergoing a clinical examination, attend the transdisciplinary intervention sessions once a week (minimum attendance required: 90%) be authorized to participate by their parents or caretakers. The children in the control group were not submitted to the intervention and were not participating in any other program involving obesity control or supervised physical activity. All children (G1+G2) were instructed to maintain their habitual level of physical activity and attend the school's regular physical education classes. The latter were scheduled twice a month during the first term and four times a month during the second. The decision to increase the frequency was made by the school's director in acknowledgment of the importance of physical activity, but the change affected the two groups equally. Exclusion Criteria: Children were ineligible if they had chronic diseases (defined as diseases requiring continuous therapy), mental disorders or cognitive impairments which might interfere with communication, or used a pacemaker, or declined participation. Children in G1 missing more than 10% of the total intervention sessions were excluded from the sample.
Facility Information:
Facility Name
Carminda Maria Goersch Fontenele Lamboglia
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60.811-905
Country
Brazil

12. IPD Sharing Statement

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Transdisciplinary Program Against Childhood Obesity

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