Condition category
Pregnancy and Childbirth
Date applied
14/12/2007
Date assigned
14/12/2007
Last edited
21/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Carlos Martines

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 2634
martinesj@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NCH 07006

Study information

Scientific title

Acronym

Study hypothesis

Does a public health intervention aimed at promoting improved feeding practices delivered at home and facility levels increase the duration of exclusive breastfeeding in the first 6 months of life and reduce the prevalence of obesity among infants 6 - 12 months?

Ethics approval

Ethics approval received from:
1. World Health Organization (WHO) Ethics Review Committee on the 21st November 2007 (ref: NCH07006)
2. Comite de Etica de la Investigacion (Cuba) on the 20th November 2007

Study design

This is a cluster-randomised controlled trial of a public health intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Infant feeding practices

Intervention

Intervention group:
Promotion of improved feeding at the health facility and community levels using multiple channels:
1. Face-to-face
2. Community based media
3. Community groups

Control group:
Receives usual care.

Some of the details of the intervention, such as the frequency or duration of contact or exposure to the channels will only be fully defined at the end of the formative research phase. Interventions at the health facility level may include in-service training of the physicians and nurses in the health centres to improve their communication and counselling skills. Training of health workers and community counselors in this course will, we believe, be an important component of the intervention. The intervention may also include changes in management procedures to make them more compatible with family needs and expectations. Access to off-hour advice, privacy of consultations, triage and waiting time and characteristics of the waiting room are some of the examples of areas that may be considered for improvement.

Interventions at the community level will make maximal use of appropriate existing channels either to be the primary sources of dissemination of messages or to re-enforce them. In addition to face-to-face communications individually or in group, the team will also consider the use of local mass media (e.g. local radio, pamphlets, banners, and posters), work and social clubs. The intervention will probably include the provision of information and the development with families of problem-solving approaches/strategies to deal with significant constraints. Face-to-face counselling will be one of the key components. Additional components may be included to remove existing barriers or promote actions that will support an increase in prevalence of a desired behaviour (for example, making breastfeeding counsellors available in the community for greater ease of access to counselling and support when mothers face a feeding difficulty).

Eighteen months after the introduction of the intervention, when we expect that the intervention will have been fully functional in all intervention clusters for at least 12 months, the post-intervention survey will be conducted to measure the impact on infants up to 12 months old. The length of exposure to the intervention will depend on the age of the infant and the period he/she has been residing in the community. Control clusters will continue to be provided the usual type of health care.

Contact details for Principal Investigator:
Dr Ibargollen Negrin Longina
Ministerio de Salud Publica
MCH Division
Calle 23 entre M y N. Vedado
Havana
Cuba
Tel: +53 (0)7 833 2336

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Prevalence of exclusive breastfeeding among infants up to 6 months of age
2. Prevalence of "recommended infant feeding practices" (continued breastfeeding and three complementary feeds/day) at 6 - 11 months
3. Prevalence of Body Mass Index (BMI)/age equal of greater than 2SD at 6 - 11 months

Secondary outcome measures

1. Diarrhoea and pneumonia in the 2 weeks before interview
2. Hospitalisations in the past year (and their cause)

Overall trial start date

01/11/2007

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Participants are all infants living in the community area served by health centres included in the study.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

12800

Participant exclusion criteria

The only exclusion criteria identified is the patient's refusal to participate.

Recruitment start date

01/11/2007

Recruitment end date

31/10/2010

Locations

Countries of recruitment

Cuba

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

Sponsor details

Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 2634
mertinesj@who.int

Sponsor type

Research organisation

Website

http://www.who.int/child-adolescent-health

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO) (Switzerland) (ref: NCH 07006)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

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

Publication citations

Additional files

Editorial Notes