Plain English Summary

Not provided at time of registration

Trial website

http://www.pact.no

Contact information

Type

Scientific

Primary contact

Prof Roar Johnsen

ORCID ID

Contact details

ISM
NTNU
Trondheim
N-7489
Norway
roar.johnsen@ntnu.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A controlled, population-based intervention study for the Prevention of Atopy among Children in Trondheim

Acronym

PACT

Study hypothesis

The primary objective of the PACT trial is to study the efficacy of an intervention on three assumed risk factors for atopic disease (AD), asthma, and allergic rhinoconjunctivitis (ARC) in an unselected population of pregnant women and small children. Further, to study the effectiveness of intervening on these risk factors on the incidence of asthma and allergic disease.
1. Omega-3 fatty acid intake
2. Second hand smoke (SHS) exposure
3. Indoor “dampness”

The prospective structure and longevity of the PACT study enables etiological studies as well as prospective and nested case-cohort studies, and controlled clinical trials. Accordingly, three sub-studies, and an end-point study, were designed.

Publications under review (at time of registration)
1. Dotterud CK, Storro O, Johnsen R., Oien T. Probiotics in non-selected pregnant women in prevention of allergic disease: a randomised, double-blind, placebo-controlled trial. J Allergy Clin Immun. Under review June 2009.
2. Smidesang I, Saunes M, Storro O, Øien T, Holmen TL, Johnsen R. et al. Allergy related disorders among 2-year olds in a general population.The PACT study. Pediatric Allergy and Immunology. Under review June 2009.

Further reading:
2007 results of the Young-Hunt study on psychological morbidity in adolescents with atopic dermatitis in http://www.ncbi.nlm.nih.gov/pubmed/17223868

Ethics approval

1. Approved by the Regional Committee for Research Ethics in Middle Norway,15/08/2000, ref: 120-2000
2. The Norwegian Data Inspectorate (ref: 2003/953-3 KBE/-) and the Probiotic study is registered in ClinicalTrials.gov (identifier NCT00159523)

Study design

Prospective controlled population-based intervention study

Primary study design

Interventional

Secondary study design

Other

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Atopic and allergic diseases in early childhood; atopic eczema; allergic rhinoconjunctivitis; asthma

Intervention

1. Increased omega-3- fatty acid intake in pregnancy and for children up to 2 years of age.
2. Reduced smoking behaviour and smoking cessation in pregnancy, reduced second hand smoke (SHS) exposure for mother and child after birth, smoking relapse prevention.
3. Reduced indoor “dampness” exposure

The interventions continue in all scheduled contacts with GPs, maternity care nurses and midwifes throughout the study period from early pregnancy until the child is 2 years of age. This schedule in incorporated as the recommended follow-up for all pregnant women in the community in the intervention period.

Brochures with information for participants were delivered at inclusion with updates at relevant contacts at 6 weeks postnatal, 1 year and 2 years after birth.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Self-reported changes in risk factor exposure and behaviour reported in repeated questionnaires in pregnancy, 6 weeks postnatal an at 1 and 2 and 6 years after birth

Secondary outcome measures

Changes in prevalence of atopic disease when the child was 2 years of age and 6 years of age

Overall trial start date

01/09/2000

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

All pregnant women living in the community of Trondheim, Norway willing to complete repeated questionnaires on risk factors and disease during pregnancy and until their child was 6 years of age could be included in the study

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

14000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2000

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Norway

Trial participating centre

ISM, NTNU
Trondheim
N-7489
Norway

Sponsor information

Organisation

Norwegian University of Science and Technology (Norway)

Sponsor details

Department of Community Medicine and general Practice
MTFS
Trondheim
N-7489
Norway
ola.storro@ntnu.no

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Norwegian Department of Health and Social affairs (Norway) - (1997-2003)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca Norge AS (Norway) - Control cohort funding (2000-2001)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norwegian University of Science and Technology (Norges Teknisk-Naturvitenskapelige Universitet [NTNU]) (Norway) - Research fellow scholarship (1999-2003)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norwegian Research Council (Norway) - Research fellow scholarship (1999-2003)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norwegian Medical Association (Norwary) - Grant (1999)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

SINTEF Unimed (Norway) - Grant (1999)

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

1. Jenssen J., Storrø O., Øien T., Johnsen R. Prevention of allergy among children in Trondheim. Allergi i praksis 4, 34-38. 2001. [in Norwegian]
2. 2008 results on atopic dermatitis in 2-year olds in http://www.ncbi.nlm.nih.gov/pubmed/18304146
3. 2008 results on minimal smoking intervention for pregnant women and their partners in http://www.ncbi.nlm.nih.gov/pubmed/19666630
4. 2008 results on assessing atopic disease in 2-6 year olds in http://www.ncbi.nlm.nih.gov/pubmed/18345462
5. 2009 results on maternal smoking cessation during pregnancy and child weight in http://www.ncbi.nlm.nih.gov/pubmed/18602227
6. 2009 results on early intake of fish oils for prevention in http://www.ncbi.nlm.nih.gov/pubmed/19666630
7. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20667103
8. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21599876
9. 2012 allergy test substudy results in http://www.ncbi.nlm.nih.gov/pubmed/21960289
10. 2012 asthma results in http://www.ncbi.nlm.nih.gov/pubmed/23095804
11. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23394141
12. 2013 bifidobacteria results in http://www.ncbi.nlm.nih.gov/pubmed/23124244

Publication citations

  1. Results on minimal smoking intervention for pregnant women and their partners

    Oien T, Storrø O, Johnsen R, Do early intake of fish and fish oil protect against eczema and doctor-diagnosed asthma at 2 years of age? A cohort study., J Epidemiol Community Health, 2010, 64, 2, 124-129, doi: 10.1136/jech.2008.084921.

  2. Results on maternal smoking cessation during pregnancy and child weight

    Fasting MH, Øien T, Storrø O, Nilsen TI, Johnsen R, Vik T, Maternal smoking cessation in early pregnancy and offspring weight status at four years of age. A prospective birth cohort study., Early Hum. Dev., 2009, 85, 1, 19-24, doi: 10.1016/j.earlhumdev.2008.05.009.

  3. Results on early intake of fish oils for prevention

    Oien T, Storrø O, Johnsen R, Do early intake of fish and fish oil protect against eczema and doctor-diagnosed asthma at 2 years of age? A cohort study., J Epidemiol Community Health, 2010, 64, 2, 124-129, doi: 10.1136/jech.2008.084921.

  4. Results

    Storrø O, Oien T, Dotterud CK, Jenssen JA, Johnsen R, A primary health-care intervention on pre- and postnatal risk factor behavior to prevent childhood allergy. The Prevention of Allergy among Children in Trondheim (PACT) study., BMC Public Health, 2010, 10, 443, doi: 10.1186/1471-2458-10-443.

  5. Results

    Saunes M, Øien T, Storrø O, Johnsen R, Family eczema-history in 2-year-olds with eczema; a prospective, population-based study. The PACT-study, Norway., BMC Dermatol., 2011, 11, 11, doi: 10.1186/1471-5945-11-11.

  6. Allergy test substudy results

    Rø AD, Saunes M, Smidesang I, Storrø O, Oien T, Moen T, Johnsen R, Agreement of specific IgE and skin prick test in an unselected cohort of two-year-old children., Eur. J. Pediatr., 2012, 171, 3, 479-484, doi: 10.1007/s00431-011-1580-9.

  7. Asthma results

    Saunes M, Øien T, Dotterud CK, Romundstad PR, Storrø O, Holmen TL, Johnsen R, Early eczema and the risk of childhood asthma: a prospective, population-based study., BMC Pediatr, 2012, 12, 168, doi: 10.1186/1471-2431-12-168.

  8. Results

    Dotterud CK, Storrø O, Simpson MR, Johnsen R, Øien T, The impact of pre- and postnatal exposures on allergy related diseases in childhood: a controlled multicentre intervention study in primary health care., BMC Public Health, 2013, 13, 123, doi: 10.1186/1471-2458-13-123.

  9. Bifidobacteria results

    Avershina E, Storrø O, Øien T, Johnsen R, Wilson R, Egeland T, Rudi K, Bifidobacterial succession and correlation networks in a large unselected cohort of mothers and their children., Appl. Environ. Microbiol., 2013, 79, 2, 497-507, doi: 10.1128/AEM.02359-12.

  10. Smidesang I, Saunes M, Storrø O, Øien T, Holmen TL, Johnsen R, Henriksen AH, Atopic dermatitis among 2-year olds; high prevalence, but predominantly mild disease--the PACT study, Norway., Pediatr Dermatol, 25, 1, 13-18, doi: 10.1111/j.1525-1470.2007.00574.x.

  11. Øien T, Storrø O, Johnsen R, Assessing atopic disease in children two to six years old: reliability of a revised questionnaire., Prim Care Respir J, 2008, 17, 3, 164-168, doi: 10.3132/pcrj.2008.00023.

Editorial Notes