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 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
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
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

Sponsor information

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

PO Box 30
Tampere
33501
Finland

Email	mikael.fogelholm@uta.fi
Website	http://www.ukkinstituutti.fi/en/
"ROR"	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

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 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	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