Condition category
Pregnancy and Childbirth
Date applied
23/02/2007
Date assigned
06/03/2007
Last edited
07/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ukkinstituutti.fi/upload/jy2xgvvr.doc

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

http://www.ukkinstituutti.fi/en/

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes