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Evidence of an Intervention on Childhood BMI z ScoreNCT01397123

The Impact of an Intervention Taught by Trained Teachers on Childhood BMI z Score

A study testing Training teachers on healthier lifestyles in people with Evidence of an Intervention on Childhood BMI z Score, run by University of Minho at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the effects of a six months nutrition intervention, delivered and taught by classroom teachers with in-service nutrition training, on the prevention of overweight and obesity among children in grades 1 to 4. Read more about this study

Who is it for?
Ages 5 to 12 years
What is being tested?
Training teachers on healthier lifestyles
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
464 participants
Where
1 sitePortugal
Study dates
Sep 2007to Jun 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children from the schools involved in the study with informed consent provided by parents.

Who cannot join

  • Age more than 12

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Santos Simões group of schools

    Guimarães, Braga District, 4810

Other trials in Portugal

About this study

The purpose of this study is to assess the effects of a six months nutrition intervention, delivered and taught by classroom teachers with in-service nutrition training, on the prevention of overweight and obesity among children in grades 1 to 4.

In this randomized controlled trial, 464 children from seven elementary schools were allocated to a six months nutrition educational intervention by their own teachers or to standard care. Intervened teachers had 12 sessions of three hours each with the researchers throughout six months, according to the following topics: nutrition and healthy eating (sessions 1 to 4); the importance of drinking water (session 5); strategies to encourage fruits and vegetables consumption and to decrease high energy-density foods intake (sessions 6 to 8); strategies to increase physical activity (sessions 9 and 10); and healthy cooking activities (sessions 11 and 12). After each session, teachers were encouraged to develop activities in class that focused on the learned topics. Sociodemographic, anthropometric, dietary, and physical activity assessments were performed at baseline and the end of intervention.

Read more

We expect that fewer intervened children become overweight and the consumption of fruit and vegetables will be higher. In addition, we expect a less consumption of low-nutrition high dense foods.

We also expect to provide further support to decrease overweight epidemic, involving classroom teachers in a training intervention and making them dedicated interventionists.

Read the detailed description

The prevalence of obesity continues to increase (Ogden et al., 2006) and is growing concerns in Portugal and in the world. As successful treatments have been elusive, the prevention should be considered a high priority. So, present efforts are being dedicated to develop and implement overweight and obesity prevention interventions (Gortmaker, et al, 1999; James, Tomas \& Kerr, 2004), in the hope that multilevel approach, if occur early in childhood, may improve eating habits and physical activity and therefore, contribute to prevent or reverse this epidemic state.

In each school, previously trained persons performed anthropometric evaluation, using standardized procedures (WHO Expert Commitee 1995). Anthropometric measurements were performed in children with light indoor clothing and barefooted. Weight was measured in an electronic scale, with an error of ±100g (Seca, Model 703, Germany), and height was measured using a stadiometer, with the head in the Frankfort plane. BMI was computed as mass, Kg/height, m2. The prevalence of underweight, normal weight, overweight and obesity was calculated according to the International Obesity Task Force (IOTF) criteria, making a correspondence between the traditional adult cut-off and specific values for children according to gender and age (Cole et al. 2000). A z-score (the number of standard deviations (SD) from the reference population) was calculated for each child using the LMS method and the calculation was determined using the LMS growth add-in for excel (Pan and Cole 2009).

Dietary intake was gathered by 24h dietary recalls obtained by nutritionists and/or trained interviewers. We assessed a single recall before and another after the intervention. The respondents had no prior notification of when the recalls would occur. Training of interviewers included practice using photos and food models to quantify portion sizes, experience in probing information from children without suggesting responses as well as the type of food consumed in detail of fat content, brand name, constituents of mixed dishes and so on. The 24h dietary recall is the most commonly used dietary assessment method because it is easy to administer, can be performed in large-scale studies (Kranz and Sie-Riz 2002, Gomez-Martínez et al. 2009), and can be used to assess adequacy of energy and macronutrient intakes. During the 24h dietary recall, each child was asked to recall all food and beverages consumed during the past 24h. Daily routines were used as prompts (waking up, going to bed, time between classes, and before or after school) to enhance recall. Portion sizes of foods and beverages consumed were also estimated using food models, photos and other props (cups, glasses, food wrappers or containers) as an aid in determining serving sizes. Energy and nutritional intake were estimated using an adapted Portuguese version of the nutritional analysis software Food Processor Plus (ESHA Research Inc., Salem, OR, USA). The 24-hour dietary recall interviews captured the time and name of each eating occasion, the foods and beverages reported at each eating occasion, and the source from which item was obtained.

In order to assess the level of physical activity of children, parents were asked five questions with four answer choices (4-point scale) ranging from 0 (very seldom) to 4 (very often): a) Outside the school does your child take part in organized sport? b) Outside school does your child take part in non-organized sport? c) Outside school, how many times a week does your child take part in sport or physical activity for at least 20 minutes? d) Outside school hours, how many hours a week does your child usually take part in physical activity so much that he gets out of breath or sweat? e) Does your child take part in competitive sport? (Mota and Esculcas 2002). The total sum of the points was computed reaching a maximum of 20 points. To express the activity levels, a Physical Activity Index was obtained, which divided the sample into four activity classes: sedentary group (0-5); low activity group (6-10); moderately active group (11-15); and vigorously active group (16-20), on the basis of their reported physical activity (Mota and Esculcas 2002).

Social, demographic and family characteristics were assessed by questionnaire. The survey sent to parents contained questions about gender and age of children, education of the parents (recorded in five categories: 0, 1-4, 5-9, 10-12, and more than 12 years of formal education). This information was further grouped for analysis into three categories: up to 9 years, 10-12 years, and more than 12 years of education.

The research team proposed, in January 2008, the accreditation of the sessions that were developed with the teachers to the Minister of Education, Scientific-Pedagogic Council for In-service Training (Conselho Científico Pedagógico da Formação Contínua, Ministério da Educação). This proposal was approved in September 2008 in the form of "training workshop" with 72 hours duration, distributed by active learning strategies (36 hours) and work contact with the children (36 hours). Teachers of the intervention group had 12 sessions of three hours each with the researchers throughout six months, which included the following topics: nutrition and healthy eating for the children and the families (sessions 1 to 4); the importance of the water (session 5); strategies to encourage fruits and vegetables consumption and to decrease high energy density foods intake (sessions 6 to 8); to increase physical activity and to reduce screen time exposure (sessions 9 and 10); and healthy cooking (sessions 11 and 12). After each session, teachers resend the learned contents to develop creative and engaging classroom activities about the addressed topic. All the questions that arose during the implementation of classroom activities were addressed and resolved shortly with the researchers. Teachers were allowed to develop and refine the activities and learning strategies that were proposed by researchers. At the end of this period, the teachers delivered a critical report of activities focused on the work contact with children.

The data analysis was performed using SPSS ®, Version 18.0 (SPSS Inc; Chicago, IL).

Being tested
Training teachers on healthier lifestyles
Keywords
BMI z-score, children, overweight, school-based intervention, trained teachers, fruit, vegetables, Low nutrition energy dense foods
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training teachers on healthier lifestylesOther

    During 2007/2008 seven out of eighty public elementary public schools from Guimarães (Portugal) were invited to participate in this study. The number of schools involved was according to constraints of personnel for the assessment and intervention. Schools were the unit of randomization and three were assigned into intervention, and four into control group. Data was collected prior to intervention and immediately after, during the year 2009 (post-intervention). Prior to participation on data collection, parents provided informed consent, and children provided oral assent.

Study groups in NCT01397123
Study groupRoleWhat they receive
Lifestyle counselingExperimentalNot described
Receives: Other: Training teachers on healthier lifestyles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI z score

    Measured: the first 3 months after the intervention

Secondary outcomes (1)
  1. dietary intake

    Measured: within the first 3 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2011 (estimated)
  2. Study startSep 2007
  3. Primary completionJun 2008
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01397123
Sponsor's protocol ID
1845
Other IDs
7613/2008
Status last verified
Jul 2011
First submitted
28 Jun 2011
Last updated
19 Jul 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.

    PubMed 10797032
  • Kranz S, Siega-Riz AM. Sociodemographic determinants of added sugar intake in preschoolers 2 to 5 years old. J Pediatr. 2002 Jun;140(6):667-72. doi: 10.1067/mpd.2002.124307.

    PubMed 12072868
  • Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.

    PubMed 16595758
  • Goldberg GR, Black AE, Jebb SA, Cole TJ, Murgatroyd PR, Coward WA, Prentice AM. Critical evaluation of energy intake data using fundamental principles of energy physiology: 1. Derivation of cut-off limits to identify under-recording. Eur J Clin Nutr. 1991 Dec;45(12):569-81.

    PubMed 1810719
  • Gomez-Martinez S, Martin A, Romeo J, Castillo M, Mesena M, Baraza JC, Jimenez-Pavon D, Redondo C, Zamora S, Marcos A. Is soft drink consumption associated with body composition? A cross-sectional study in Spanish adolescents. Nutr Hosp. 2009 Jan-Feb;24(1):97-102.

    PubMed 19266121
  • Mota J, Esculcas C. Leisure-time physical activity behavior: structured and unstructured choices according to sex, age, and level of physical activity. Int J Behav Med. 2002;9(2):111-21. doi: 10.1207/s15327558ijbm0902_03.

    PubMed 12174530
  • Schofield WN. Predicting basal metabolic rate, new standards and review of previous work. Hum Nutr Clin Nutr. 1985;39 Suppl 1:5-41.

    PubMed 4044297
  • Rosario R, Araujo A, Padrao P, Lopes O, Moreira A, Pereira B, Moreira P. Health Promotion Intervention to Improve Diet Quality in Children. Health Promot Pract. 2017 Mar;18(2):253-262. doi: 10.1177/1524839916634096. Epub 2016 Jul 9.

    PubMed 27095035

Questions about this trial

What is this clinical trial studying?

A study testing Training teachers on healthier lifestyles in people with Evidence of an Intervention on Childhood BMI z Score, run by University of Minho at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI z score (time frame: the first 3 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01397123, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2011.

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