Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Mieke de Haan


Contact details

EMGO instituut
Afd. Sociale Geneeskunde
Van der Boechorststraat 7
1081 BT
+31 (0)20 444 8108

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Nurse Family Partnership

Study hypothesis

Compared to children receiving usual care, children receiving the Nurse Family Partnership (NFP)-intervention will have better birth outcome, growth and development, psycho-social outcomes and behavioural outcomes in the first years of life, and also later in life.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, single blinded trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Pregnancy in at-risk mothers-to-be


Intervention group:
The Nurse Family Partnership intervention consists of an intensive schedule of approximately 30 home visits (maximal 60) by experienced youth health nurses. The home visits will start from the 16th week of pregnancy and will last until the child is two years of age. The frequency is about two visits each month with a higher frequency (once a week) in the first month of the programme and the first six weeks after birth, with a declining frequency (once a month) in the last four months. Every home visit lasts one to 1.5 hours.

Control group:
Care as usual.

Intervention type



Not Specified

Drug names

Primary outcome measures

1. At the start of the study women will be interviewed about the following conditions:
a. physical: diseases, diet, cigarette smoking, drug abuse, etc.
b. emotional: feelings of anxiety and depression, a history of abuse or neglect
c. relational: partner, social support
d. social determinants: education, financial problems, housing, use of current health care
The mothers' sense of control about her circumstances is determined. Partners are being asked to report emotional or behavioural problems. A urine sample will be taken to determine urinary infections

2. During the entire study measurements of the following will be used in the study:
a. height and weight
b. breast- or bottle-feeding
c. development according to Van Wiechen classification scheme
These will be collected by the regular health system will be used in the study. Also, data of the delivery and first week after birth will be collected from the files of primary health care.

3. At the age of six months, we measure development, anxiety and mother-child interactions.

4. At the ages of one and two years the home situation will be observed according to:
a. safety
b. availability of food and fruit and of toys

5. At the age of two other determinants are:
a. child abuse
b. finance
c. home
d. education
e. anti-conception
f. pregnancies
g. stability relation with the father
h. psychopathology of the mother

Secondary outcome measures

1. Pre-conditions necessary for an optimal implementation
2. Cost-effectiveness of the intervention

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. No previous born child (a number of pregnant women did have an abortion)
2. Pregnancy duration of maximum 28 weeks
3. Low education grade
4. Some knowledge of the Dutch language
5. Furthermore, one or more of the following secondary inclusion criteria:
a. no (supportive) social network or partner
b. alcohol or drug abuse
c. actual violence in family or partner
d. history of abuse
e. psychological problems such as anxiety or depression
f. non-realistic approach about motherhood
g. drop-out of school
h. unemployed
i. financial or housing-problems

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Heavy psychiatric problems or obvious psychosis
2. Heavy drugs or alcohol addiction

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

EMGO instituut
1081 BT

Sponsor information


VU University Medical Centre (The Netherlands)

Sponsor details

Department of Public Health
P.O. Box 7057
1007 MB

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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. 2011 study design in

Publication citations

  1. Study design

    Mejdoubi J, van den Heijkant S, Struijf E, van Leerdam F, HiraSing R, Crijnen A, Addressing risk factors for child abuse among high risk pregnant women: design of a randomised controlled trial of the nurse family partnership in Dutch preventive health care., BMC Public Health, 2011, 11, 823, doi: 10.1186/1471-2458-11-823.

Additional files

Editorial Notes