Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Riitta Luoto
ORCID ID
Contact details
The UKK Institute for Health Promotion Research
PO Box 30
Tampere
33501
Finland
+358 3 2829226
riitta.luoto@uta.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
NELLI (Lifestyle and counseling in maternity and child health care [Neuvonta, Elintavat ja Liikunta neuvolassa, in Finnish])
Study hypothesis
The primary aim of this pilot study is to test the feasibility of the trial. The secondary aims are to test whether individual counseling on physical activity and diet and supervised group exercise sessions have an effect on leisure time physical activity, dietary habits, gestational weight gain and postpartum weight retention.
Ethics approval
The Ethics Committee of the Pirkanmaa Hospital District, approved on 24 August 2004. Ref: R04047
Study design
Non-randomized controlled trial, clinics are allocated to intervention and control clinics (not individuals)
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Excessive gestational weight gain and postpartum weight retention
Intervention
40 pregnant and 40 postpartum women in the intervention and control clinics participated in the study (total 160 women).
The intervention included individual counselling on diet and physical activity during five routine visits to a public health nurse in primary health care. These visits were at 8-9, 16-18, 22-24, 32-34 and 36-37 weeks' gestation or at 2, 3, 5, 6 and 10 months postpartum. The counseling focused on promoting healthy dietary and physical activity habits. The participants in the intervention clinics had also an option to participate in group exercise sessions once a week (60 min). The participants of the control clinicss received the usual care.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The feasibility of the study protocol, e.g. participation rate, drop-out-rate, success of data collection, realization of the counseling sessions, participation rate in the group exercise sessions, advers events.
Secondary outcome measures
1. Dietary habits (proportion of women having breakfast and at least one hot meal per day; intake of vegetables, fruit and berries; proportion of high-fiber bread of total weekly amount of bread; intake of high-sugar snacks)
2. Leisure time physical activity (days and mins of at least moderate intensity physical activity, total weekly metabolic equivalent minutes [METmins])
3. Proportion of pregnant women exceeding the recommendations for gestational weight gain (Institute of Medicine 1990)
4. Proportion of women returning to their pre-pregnancy weight by 10 months postpartum
Maternal wellbeing
5. Levels of selected breast cancer risk markers (hormones, growth factors) in blood and nipple aspirate fluid (only in postpartum women)
Institute of Medicine. Nutrition during pregnancy, weight gain and nutrient supplements. Report of the Subcommittee on Nutritional Status and Weight Gain during Pregnancy, Subcommittee on Dietary Intake and Nutrient Supplements during Pregnancy, Committee on Nutritional Status during Pregnancy and Lactation, Food and Nutrition Board. Washington, DC: National Academy Press, 1990:1-233.
Overall trial start date
11/08/2004
Overall trial end date
30/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant (at 8-9 weeks' gestation) and postpartum (2 months postpartum) women with no earlier deliveries
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80 pregnant and 80 postpartum women, 160 in total
Participant exclusion criteria
1. Age <18 years
2. Type 1 or 2 diabetes mellitus
3. Twin pregnancy
4. Physical disability that prevents from exercising
5. Otherwise problematic pregnancy (based on physician estimation)
6. Substance abuse
7. Treatment or clinical history for any psychiatric illness and women who are going to change residence within three months
Recruitment start date
11/08/2004
Recruitment end date
30/09/2005
Locations
Countries of recruitment
Finland
Trial participating centre
The UKK Institute for Health Promotion Research
Tampere
33501
Finland
Sponsor information
Organisation
The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
Sponsor details
PO Box 30
Tampere
33501
Finland
mikael.fogelholm@uta.fi
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Doctoral Programs in Public Health (DPPH) (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institutes of Health (USA)
Alternative name(s)
NIH
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
Funder name
Ministry of Education (Finland)
Alternative name(s)
Ministry of Education of the Republic of Korea, MOE
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Korea, South
Funder name
Ministry of Social Affairs and Health (Finland)
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. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17228348
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18694479
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20932282
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22568871
5. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22307101
Publication citations
-
Results
Mustila T, Raitanen J, Keskinen P, Saari A, Luoto R, Lifestyle counseling during pregnancy and offspring weight development until four years of age: follow-up study of a controlled trial., J Negat Results Biomed, 2012, 11, 11, doi: 10.1186/1477-5751-11-11.
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Results
Mustila T, Raitanen J, Keskinen P, Saari A, Luoto R, Lifestyle counselling targeting infant's mother during the child's first year and offspring weight development until 4 years of age: a follow-up study of a cluster RCT., BMJ Open, 2012, 2, 1, e000624, doi: 10.1136/bmjopen-2011-000624.
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Kinnunen TI, Pasanen M, Aittasalo M, Fogelholm M, Hilakivi-Clarke L, Weiderpass E, Luoto R, Preventing excessive weight gain during pregnancy - a controlled trial in primary health care., Eur J Clin Nutr, 2007, 61, 7, 884-891, doi: 10.1038/sj.ejcn.1602602.
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Kinnunen TI, Aittasalo M, Koponen P, Ojala K, Mansikkamäki K, Weiderpass E, Fogelholm M, Luoto R, Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care., BMC Pregnancy Childbirth, 2008, 8, 37, doi: 10.1186/1471-2393-8-37.
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Luoto R, Kharazmi E, Saarinen NM, Smeds AI, Mäkelä S, Fallah M, Raitanen J, Hilakivi-Clarke L, Effect of dietary intervention on serum lignan levels in pregnant women - a controlled trial., Reprod Health, 2010, 7, 26, doi: 10.1186/1742-4755-7-26.