Transdisciplinary Program Against Childhood Obesity

Childhood Obesity Clinical Trial

— OTPACO  

Official title:

Outcome of a 1-year Transdisciplinary Program Against Childhood Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453269
• Other study ID #: TRANS 123
• Status: Completed
• Phase: N/A
• First received: April 13, 2015
• Last updated: May 20, 2015
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Fortaleza University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the outcome of a 1-year transdisciplinary program against childhood obesity.

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 schoolʼs 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 schoolʼs 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 participantsʼ 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 schoolʼs 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 participantʼs stage of growth, development and maturity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Transdisciplinary program

Locations

Country	Name	City	State
Brazil	Carminda Maria Goersch Fontenele Lamboglia	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Fortaleza University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height (cm) (outcome)		Participants were followed for the duration of one year	Yes
Primary	Body mass (kg) (outcome)		Participants were followed for the duration of one year	Yes
Primary	Body mass index (kg/m2) (outcome)		Participants were followed for the duration of one year	Yes
Primary	Waist circumference (cm) (outcome)		Participants were followed for the duration of one year	Yes
Primary	Waist circunference/height ratio (outcome)		Participants were followed for the duration of one year	Yes
Primary	Body fat percentage (%) (outcome)		Participants were followed for the duration of one year	Yes
Primary	Fat body mass (kg) (outcome)		Participants were followed for the duration of one year	Yes
Primary	Lean body mass (kg) (outcome)		Participants were followed for the duration of one year	Yes
Primary	Abdominal strength (repetition) (outcome)		Participants were followed for the duration of one year	Yes
Primary	Flexibility (cm) (outcome)		Participants were followed for the duration of one year	Yes