Comprehensive care of infants: development and evaluation of an intervention strategy to enhance the promotion of health and quality of life of infants 2007 - 2010
| ISRCTN | ISRCTN46535923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46535923 |
| Secondary identifying numbers | NCH 07006 |
- Submission date
- 14/12/2007
- Registration date
- 14/12/2007
- Last edited
- 21/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Carlos Martines
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 2634 |
|---|---|
| martinesj@who.int |
Study information
| Study design | This is a cluster-randomised controlled trial of a public health intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2007 |
| Completion date | 31/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 12800 |
| Key inclusion criteria | Participants are all infants living in the community area served by health centres included in the study. |
| Key exclusion criteria | The only exclusion criteria identified is the patient's refusal to participate. |
| Date of first enrolment | 01/11/2007 |
| Date of final enrolment | 31/10/2010 |
Locations
Countries of recruitment
- Cuba
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 2634 |
|---|---|
| mertinesj@who.int | |
| Website | http://www.who.int/child-adolescent-health |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Switzerland) (ref: NCH 07006)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
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 |
