Physical activity and dietary counseling and supervised group exercise for first-time pregnant women - a feasibility study of a controlled trial
ISRCTN | ISRCTN21512277 |
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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
Contact information
Dr Riitta Luoto
Scientific
Scientific
The UKK Institute for Health Promotion Research
PO Box 30
Tampere
33501
Finland
Phone | +358 3 2829226 |
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riitta.luoto@uta.fi |
Study information
Study design | Non-randomized controlled trial, clinics are allocated to intervention and control clinics (not individuals) |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study acronym | NELLI (Lifestyle and counseling in maternity and child health care [Neuvonta, Elintavat ja Liikunta neuvolassa, in Finnish]) |
Study objectives | 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(s) | The Ethics Committee of the Pirkanmaa Hospital District, approved on 24 August 2004. Ref: R04047 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 11/08/2004 |
Completion date | 30/09/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 80 pregnant and 80 postpartum women, 160 in total |
Key inclusion criteria | Pregnant (at 8-9 weeks' gestation) and postpartum (2 months postpartum) women with no earlier deliveries |
Key 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 |
Date of first enrolment | 11/08/2004 |
Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- Finland
Study participating centre
The UKK Institute for Health Promotion Research
Tampere
33501
Finland
33501
Finland
Sponsor information
The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
Research organisation
Research organisation
PO Box 30
Tampere
33501
Finland
mikael.fogelholm@uta.fi | |
Website | http://www.ukkinstituutti.fi/en/ |
https://ror.org/05ydecq02 |
Funders
Funder type
Government
Doctoral Programs in Public Health (DPPH) (Finland)
No information available
National Institutes of Health (USA)
Government organisation / National government
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
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 | |
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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 | 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 |