NCT02453269

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

April 13, 2015

Last Update Submit

May 20, 2015

Conditions

Keywords

ObesityChildrenHealth Colective

Outcome Measures

Primary Outcomes (10)

  • Height (cm) (outcome)

    Participants were followed for the duration of one year

  • Body mass (kg) (outcome)

    Participants were followed for the duration of one year

  • Body mass index (kg/m2) (outcome)

    Participants were followed for the duration of one year

  • Waist circumference (cm) (outcome)

    Participants were followed for the duration of one year

  • Waist circunference/height ratio (outcome)

    Participants were followed for the duration of one year

  • Body fat percentage (%) (outcome)

    Participants were followed for the duration of one year

  • Fat body mass (kg) (outcome)

    Participants were followed for the duration of one year

  • Lean body mass (kg) (outcome)

    Participants were followed for the duration of one year

  • Abdominal strength (repetition) (outcome)

    Participants were followed for the duration of one year

  • Flexibility (cm) (outcome)

    Participants were followed for the duration of one year

Study Arms (2)

Transdisciplinary program

EXPERIMENTAL

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).

Behavioral: Transdisciplinary program

Control group

NO INTERVENTION

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

Interventions

Transdisciplinary program

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carminda Maria Goersch Fontenele Lamboglia

Fortaleza, Ceará, 60.811-905, Brazil

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Outcome of a 1-year transdisciplinary program against childhood obesity

Study Record Dates

First Submitted

April 13, 2015

First Posted

May 25, 2015

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

November 1, 2014

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations