Physical activity and dietary counseling and supervised group exercise for first-time pregnant women - a feasibility study of a controlled trial

ISRCTN ISRCTN21512277
DOI https://doi.org/10.1186/ISRCTN21512277
Secondary identifying numbers N/A
Submission date
23/02/2007
Registration date
06/03/2007
Last edited
07/11/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Riitta Luoto
Scientific

The UKK Institute for Health Promotion Research
PO Box 30
Tampere
33501
Finland

Phone +358 3 2829226
Email riitta.luoto@uta.fi

Study information

Study designNon-randomized controlled trial, clinics are allocated to intervention and control clinics (not individuals)
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymNELLI (Lifestyle and counseling in maternity and child health care [Neuvonta, Elintavat ja Liikunta neuvolassa, in Finnish])
Study objectivesThe 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(s)The Ethics Committee of the Pirkanmaa Hospital District, approved on 24 August 2004. Ref: R04047
Health condition(s) or problem(s) studiedExcessive gestational weight gain and postpartum weight retention
Intervention40 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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date11/08/2004
Completion date30/09/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants80 pregnant and 80 postpartum women, 160 in total
Key inclusion criteriaPregnant (at 8-9 weeks' gestation) and postpartum (2 months postpartum) women with no earlier deliveries
Key exclusion criteria1. 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
Date of first enrolment11/08/2004
Date of final enrolment30/09/2005

Locations

Countries of recruitment

  • Finland

Study participating centre

The UKK Institute for Health Promotion Research
Tampere
33501
Finland

Sponsor information

The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
Research organisation

Funders

Funder type

Government

Doctoral Programs in Public Health (DPPH) (Finland)

No information available

National Institutes of Health (USA)
Government organisation / National government
Alternative name(s)
Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location
United States of America
Ministry of Education (Finland)
Government organisation / National government
Alternative name(s)
Ministry of Education of the Republic of Korea, 교육부, MOE
Location
Korea, South
Ministry of Social Affairs and Health (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2007 Yes No
Results article results 11/08/2008 Yes No
Results article results 08/10/2010 Yes No
Results article results 03/02/2012 Yes No
Results article results 08/05/2012 Yes No