Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/06/2013
Date assigned
11/07/2013
Last edited
19/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There has been an increase in prevalence of overweight and obesity (fatness) among adolescents. The overall goal of this study was to design, conduct and assess a comprehensive school-based programme to promote healthy weight development among young adolescents (11-13 year olds). The programme aimed to increase total physical activity and intake of fruit and vegetables and to decrease the time spent in front of television or computer (screen time) and consumption of sugar-sweetened drinks.

Who can participate?
All 6th grade students in the participating schools and their parents/legal guardians were invited to participate.

What does the study involve?
Schools were randomly assigned to one of two groups: 12 to the intervention group and 25 to the control group. The programme was systematically developed and consisted of a classroom component, including dietary behaviour lessons, computer-tailored personal advices, fruit/vegetable and physical activity breaks and posters and an environmental component including active transport campaigns, sports equipment for recess (break), suggestions for easy improvements of schoolyards, inspirational physical activity courses for teachers, and fact sheets to parents.

What are the possible benefits and risks of participating?
The schools got access to expertise in nutrition and physical activity, as well as some material resources to stimulate active play and fruitbreaks. The pupils were made aware of their nutritional and physical activity behaviours and given various support to improve them over a long period (20 months). The main risks of the study were that it might contribute to increased rates of unnecessary dieting among children, eating disorders or weight-related bullying. The focus was thus kept on the behaviours and teachers and school nurses were informed to report if any of these risks were observed.

Where is the study run from?
The study was conducted in seven counties in the eastern part of Norway.

When is the study starting and how long is it expected to run for?
The study started with a pre-test in September 2007 and ended with a post-test in May 2009.

Who is funding the study?
This study was funded by the Norwegian Research Council (Norway) with additional funds from Throne Holst Nutrition Research Foundation (Norway), University of Oslo (Norway), and the Norwegian School of Sport Sciences (Norway).

Who is the main contact?
Professor Nanna Lien
nanna.lien@medisin.uio.no

Trial website

https://www.med.uio.no/imb/english/research/projects/heia/index.html

Contact information

Type

Scientific

Primary contact

Prof Knut-Inge Klepp

ORCID ID

Contact details

Department of Nutrition
PO Box 1046
Blindern
Oslo
0316
Norway
k.i.klepp@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

175323/V50 Norwegian Research Council

Study information

Scientific title

Promoting healthy weight among school children

Acronym

The HEIA study

Study hypothesis

The research hypotheses to be tested in the main study are:
1. A healthy weight promotion program can be designed and successfully implemented in collaboration with schools, local health care services, community youth organizations and parents.
2. A successfully implemented healthy weight promotion program will lead to a more healthy diet and increase physical activity patterns among the children.
3. A healthy diet and increased physical activity levels will lead to reduced rates of overweight and obesity among the children.
4.The healthy weight promotion program will not contribute to increased rates of unwarranted dieting behavior among the children, or to increased rates of eating disorders.

Ethics approval

The study was approved by the Regional Committees for Medical Research Ethics (Date: 22.03.07/ Ref.number: 2.2007.743) and the Norwegian Social Science Data Service (Date: 19.06.2007/ Ref.number: 16434).

Study design

Group-based randomized controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary prevention of overweight/obesity among school-aged children.

Intervention

The study has benefited from applying the intervention mapping methodology, by including the following phases: (1) needs assessment comprising a situational analysis of weight, diet, and activity patterns and environmental and personal determinants; (2) development of specific intervention components aimed to influence determinants; (3) implementation of the intervention following intervention mapping guidelines; and (4) a thorough process and outcome evaluation of the intervention.

Twelve out of 37 schools were randomly assigned to the intervention group. The control group received no intervention, but was offered the revised material after the study was finished. The intervention program lasted for two school years (20 months, 6th and 7th grade) and was delivered by the teachers.

The intervention programme consisted of a classroom component, including dietary behavior lessons (5 lessons, 6th grade), computer tailored personal advise (5 modules 7th grade), fruit/vegetable and physical activity breaks (once weekly), and posters (one per month), and an environmental component including active transport campaigns (thrice a week), sports equipment for active recess, suggestions for easy improvement of schoolyards, inspirational courses on physical activity for teachers (1 day per year), and fact sheets to parents (one per month).

There were measurement conducted at pre-test (September 2007), midway (May 2008) and post-test (May 2009). The midway and post-test evaluation of the intervention arm included process evaluation data from teachers, pupils and parents.

The power calculations were done on 10 + 30, but we only managed to recruit 37 and we were afraid of drops outs so we increased the intervention schools to 12

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Anthropometric measures were taken by same-sex project staff in a suitable room in the schools. The height was measured to the nearest 0.1 cm, using a wall-mounted tape with the child standing upright against the wall and without shoes. The weight was measured with the child in light clothing, to the nearest 0.1 kg using Tanita scales (TBF-300; Tanita Corporation of America, Illinois, USA). The scales were new at the start of the study and were not recalibrated during the project. Waist circumference was measured to the nearest 0.1 cm with a flexible measuring tape between the lower rib and the iliac crest at the end of a normal expiration. Hip circumference was measured at the widest circumference of the hip. The pubertal scale utilised is based on the Pubertal Category Scores and included body hair growth (both genders), voice and facial hair (boys), and breast development and menarche (girls).

Potential negative consequences of the intervention were assessed in the questionnaire by two questions on weight-related cognitions (perception of own weight, its importance to self-esteem), two on receiving weight-related comments (frequency and by whom), and two on slimming behavior (frequency question and a open-ended question inquiring what they had done to slim) for those who had tried to lose or maintain weight in the last year.

Self-reported height and weight, waist, and hip circumferences were obtained from the parents/guardians through the questionnaires. Parents were provided with a measurement tape and written instructions on how to measure waist and hip circumference. The same behaviors as for the children were assessed for each of the parents. In additon, they were asked about whether encouragement of weight loss was practised among the family members. Perceived barriers and facilitators influencing their child’s level of physical activity and consumption of unhealthy foods/drinks were assessed. Finally, a food shelf inventory in the mother’s questionnaire assessed the availability of 71 items/categories of food, drinks, and dietary supplements.

Secondary outcome measures

Intake of beverages was assessed by frequency and amount (in glasses) for weekdays and by
amount for weekends. Soft drinks and squash with sugar were the main behaviors, but other
beverages (such as light soft drinks, light squash, ice tea, water, juice, nectar) were monitored to see whether decreases of the former were accompanied by increases in the latter. Frequency of consumption of fruit and raw and cooked vegetables was assessed by one question for each. In addition, frequency of consumption of sweets/chocolate, salty snacks, sweet cookies, buns/muffins, and five meals/snacks was assessed by nine questions.

Physical activity on weekdays was measured with regards to frequency and length of time spent on active transport to/from school, during recess, in PE class, and after school to assess context specific physical activity. For weekends, there was one question on frequency and one on length of time. Four questions assessed the number of hours spent on watching TV/DVDs and on surfing the internet or playing electronic games separately for weekdays and weekends.

Physical activity was also measured objectively by accelerometers to assess intensity and total
physical activity. The children wore accelerometers (GT1 M/CSA model 7164; ActiGraph, Fort
Walton Beach, FL, USA) for 5 consecutive days and were instructed to wear the monitor continuously all awake hours except when doing water activities. The output was sampled every 10 seconds for 2 weekdays and 2 weekends. The criteria defined for acceptable use of the monitor were that activity should be registered during a minimum of 3 days and at least for 8 hours each day.

Overall trial start date

01/06/2006

Overall trial end date

31/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Schools from the 3-4 large towns/municipalities in seven counties surrounding the county of Oslo (south-eastern region of Norway) and with a minimum of 40 enrolled pupils in 6th grade in fall 2007 were to be invited. All 6th grade pupils and their parents in the participating schools were eligible for participation.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

37 schools (12 intervention and 25 control) with an average of 45 pupils participating
from each school.

Participant exclusion criteria

Schools from the area of interest with less than 40 enrolled pupils in 6th grade in the fall of 2007.

Recruitment start date

01/06/2006

Recruitment end date

31/08/2012

Locations

Countries of recruitment

Norway

Trial participating centre

Department of Nutrition
Oslo
0316
Norway

Sponsor information

Organisation

The Research Council (Norges forskningsråd) (Norway)

Sponsor details

Postboks 2700 St. Hanshaugen
Stensberggata 26
Oslo
0131
Norway
post@forskningsradet.no

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

Norwegian Research Council (Norway) (grant no. 175323/V50)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Supplementary funds from:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Throne Holst Nutrition Research Foundation, University of Oslo (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norwegian School of Sport Sciences (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 design in: http://www.ncbi.nlm.nih.gov/pubmed/21062838
2010 baseline survey in: http://www.ncbi.nlm.nih.gov/pubmed/21062836
2011 baseline data in: http://www.ncbi.nlm.nih.gov/pubmed/21729482
2011 mid-way assessment results in: http://www.ncbi.nlm.nih.gov/pubmed/21679476
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21410547
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23216675
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22643014
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22995043
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23379535
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23624466
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24568125

Publication citations

  1. Design

    Lien N, Bjelland M, Bergh IH, Grydeland M, Anderssen SA, Ommundsen Y, Andersen LF, Henriksen HB, Randby JS, Klepp KI, Design of a 20-month comprehensive, multicomponent school-based randomised trial to promote healthy weight development among 11-13 year olds: The HEalth In Adolescents study., Scand J Public Health, 2010, 38, 5 Suppl, 38-51, doi: 10.1177/1403494810379894.

  2. Baseline survey

    Bjelland M, Lien N, Bergh IH, Grydeland M, Anderssen SA, Klepp KI, Ommundsen Y, Andersen LF, Overweight and waist circumference among Norwegian 11-year-olds and associations with reported parental overweight and waist circumference: The HEIA study., Scand J Public Health, 2010, 38, 5 Suppl, 19-27, doi: 10.1177/1403494810385036.

  3. Baseline data

    Bjelland M, Lien N, Grydeland M, Bergh IH, Anderssen SA, Ommundsen Y, Klepp KI, Andersen LF, Intakes and perceived home availability of sugar-sweetened beverages, fruit and vegetables as reported by mothers, fathers and adolescents in the HEIA (HEalth In Adolescents) study., Public Health Nutr, 2011, 14, 12, 2156-2165, doi: 10.1017/S1368980011000917.

  4. Results

    Bergh IH, Grydeland M, Bjelland M, Lien N, Andersen LF, Klepp KI, Anderssen SA, Ommundsen Y, Personal and social-environmental correlates of objectively measured physical activity in Norwegian pre-adolescent children., Scand J Med Sci Sports, 2011, 21, 6, e315-24, doi: 10.1111/j.1600-0838.2011.01295.x.

  5. Results

    Grydeland M, Bergh IH, Bjelland M, Lien N, Andersen LF, Ommundsen Y, Klepp KI, Anderssen SA, Correlates of weight status among Norwegian 11-year-olds: The HEIA study., BMC Public Health, 2012, 12, 1053, doi: 10.1186/1471-2458-12-1053.

  6. Results

    Bergh IH, Bjelland M, Grydeland M, Lien N, Andersen LF, Klepp KI, Anderssen SA, Ommundsen Y, Mid-way and post-intervention effects on potential determinants of physical activity and sedentary behavior, results of the HEIA study - a multi-component school-based randomized trial., Int J Behav Nutr Phys Act, 2012, 9, 63, doi: 10.1186/1479-5868-9-63.

  7. Results

    Bergh IH, van Stralen MM, Grydeland M, Bjelland M, Lien N, Andersen LF, Anderssen SA, Ommundsen Y, Exploring mediators of accelerometer assessed physical activity in young adolescents in the Health In Adolescents Study - a group randomized controlled trial., BMC Public Health, 2012, 12, 814, doi: 10.1186/1471-2458-12-814.

  8. Results

    Grydeland M, Bergh IH, Bjelland M, Lien N, Andersen LF, Ommundsen Y, Klepp KI, Anderssen SA, Intervention effects on physical activity: the HEIA study - a cluster randomized controlled trial., Int J Behav Nutr Phys Act, 2013, 10, 17, doi: 10.1186/1479-5868-10-17.

  9. Results

    Grydeland M, Bjelland M, Anderssen SA, Klepp KI, Bergh IH, Andersen LF, Ommundsen Y, Lien N, Effects of a 20-month cluster randomised controlled school-based intervention trial on BMI of school-aged boys and girls: the HEIA study., Br J Sports Med, 2014, 48, 9, 768-773, doi: 10.1136/bjsports-2013-092284.

  10. Results

    Bergh IH, van Stralen MM, Bjelland M, Grydeland M, Lien N, Klepp KI, Anderssen SA, Ommundsen Y, Post-intervention effects on screen behaviours and mediating effect of parental regulation: the HEalth In Adolescents study--a multi-component school-based randomized controlled trial., BMC Public Health, 2014, 14, 200, doi: 10.1186/1471-2458-14-200.

  11. Bjelland M, Bergh IH, Grydeland M, Klepp KI, Andersen LF, Anderssen SA, Ommundsen Y, Lien N, Changes in adolescents' intake of sugar-sweetened beverages and sedentary behaviour: results at 8 month mid-way assessment of the HEIA study--a comprehensive, multi-component school-based randomized trial., Int J Behav Nutr Phys Act, 2011, 8, 63, doi: 10.1186/1479-5868-8-63.

Additional files

Editorial Notes