PACT: Prevention of Atopy among Children in Trondheim
| ISRCTN | ISRCTN28090297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28090297 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/12/2009
- Registration date
- 08/01/2010
- Last edited
- 13/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Roar Johnsen
Scientific
Scientific
ISM, NTNU
Trondheim
N-7489
Norway
| roar.johnsen@ntnu.no |
Study information
| Study design | Prospective controlled population-based intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Other |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A controlled, population-based intervention study for the Prevention of Atopy among Children in Trondheim |
| Study 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(s) | 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) |
| 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 |
| Primary outcome measure | 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 study start date | 01/09/2000 |
| Overall study end date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 14000 |
| 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 exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/09/2000 |
| Recruitment end date | 31/12/2011 |
Locations
Countries of recruitment
- Norway
Study participating centre
ISM, NTNU
Trondheim
N-7489
Norway
N-7489
Norway
Sponsor information
Norwegian University of Science and Technology (Norway)
University/education
University/education
Department of Community Medicine and general Practice
MTFS
Trondheim
N-7489
Norway
| ola.storro@ntnu.no | |
"ROR" |
https://ror.org/05xg72x27 |
Funders
Funder type
Government
Norwegian Department of Health and Social affairs (Norway) - (1997-2003)
No information available
AstraZeneca Norge AS (Norway) - Control cohort funding (2000-2001)
No information available
Norwegian University of Science and Technology (Norges Teknisk-Naturvitenskapelige Universitet [NTNU]) (Norway) - Research fellow scholarship (1999-2003)
No information available
Norwegian Research Council (Norway) - Research fellow scholarship (1999-2003)
No information available
Norwegian Medical Association (Norwary) - Grant (1999)
No information available
SINTEF Unimed (Norway) - Grant (1999)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results on atopic dermatitis in 2-year olds | 01/01/2008 | Yes | No | |
| Results article | results on assessing atopic disease in 2-6 year olds | 01/09/2008 | Yes | No | |
| Results article | results on maternal smoking cessation during pregnancy and child weight | 01/01/2009 | Yes | No | |
| Results article | results on early intake of fish oils for prevention | 01/02/2010 | Yes | No | |
| Results article | results on minimal smoking intervention for pregnant women and their partners | 01/02/2010 | Yes | No | |
| Results article | results | 28/07/2010 | Yes | No | |
| Results article | results | 20/05/2011 | Yes | No | |
| Results article | allergy test substudy results | 01/03/2012 | Yes | No | |
| Results article | asthma results | 24/10/2012 | Yes | No | |
| Results article | bifidobacteria results | 01/01/2013 | Yes | No | |
| Results article | results | 08/02/2013 | Yes | No |
