Do food supplementation and play-based stimulation benefit the development of undernourished children?
| ISRCTN | ISRCTN31299262 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31299262 |
- Submission date
- 05/12/2019
- Registration date
- 21/01/2020
- Last edited
- 20/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Childhood stunting (low height-for-age) is associated with poor childhood development. The aims of the study are to determine the benefits for child development of nutritional supplementation (a milk-based supplement, provided weekly) and a weekly home-visit play intervention delivered by community health workers which aims to build parents skills to interact with their children in ways that promote development and early learning.
Who can participate?
Children and their main caregiver (usually their mother) identified from several poor neighbourhoods in Kingston, Jamaica. Children can participate if they are aged between 9-24 months on enrolment, and are stunted (low height-for-age). A group of non-stunted children of the same age and from the same neighbourhoods are also enrolled and followed but they do not participate in the study.
What does the study involve?
Stunted children aged 9-24 months are identified by a house-to-house survey of poor neighbourhoods in Kingston, Jamaica and randomly allocated to one of the four study groups (nutrition, play, combined interventions, no intervention). A group of non-stunted children from the same neighbourhoods are also followed but are not part of the study. Free healthcare is provided to all groups. The interventions are given singly or in combination for 2 years. Children’s development and growth are measured on enrolment and every 6 months, their home environment is assessed on enrolment and at the end of the study and information on child illnesses is obtained weekly.
What are the possible benefits and risks of participating?
The only direct benefit to children and caregivers is access to free primary health care from a family physician. The study is minimal risk. There is a possible risk that some children might not tolerate the milk-based supplement
Where is the study run from?
Tropical Metabolism Research Unit, The University of the West Indies, Kingston (Jamaica)
When is the study starting and how long is it expected to run for?
January 1986 to November 1989
Who is funding the study?
The Ford Foundation (USA)
Who is the main contact?
1. Prof. Sally Grantham-McGregor
2. Prof. Susan Walker
susan.walker@uwimona.edu.jm
Contact information
Scientific
Caribbean Institute for Health Research
The University of the West Indies, Mona
Kingston
7
Jamaica
 ORCID ID |
0000-0001-9494-1116 |
|---|---|
| Phone | +876 (0)9272471 |
| susan.walker@uwimona.edu.jm |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Scientific title | Nutritional supplementation, psychosocial stimulation and the development of stunted children: the Jamaica study |
| Study objectives | Nutritional supplementation and psychosocial stimulation will each benefit the development of stunted children and the combined intervention will have greater benefits. |
| Ethics approval(s) | Ethical approval was obtained in 1986 from the Ethics Committee of the University Hospital of the West Indies. The ethics committee at the time of the study was reorganised and the name changed. The current information is: Mona Campus Research Ethics Committee, Faculty of Medical Sciences, The University of the West Indies, Mona, Kingston 7, Jamaica; Tel: +876 (0)970 4892; Email: mcrec@uwimona.edu.jm, no approval number available |
| Health condition(s) or problem(s) studied | Child development in stunted children (height-for-age < -2SD of reference values) |
| Intervention | Stunted children aged between 9 and 24 months identified by a survey of poor neighbourhoods in Kingston were stratified by age (above or below 16 months) and sex and randomly assigned to one of four groups: supplementation, stimulation, both interventions, or a control group. Interventions were provided weekly for two years A comparison group of non-stunted children from the same neighbourhoods was also followed. Supplementation: The supplement comprised 1 kg milk-based formula per week, delivered to the home weekly. Some additional food (cornmeal and skimmed milk powder) was provided to the family to reduce the sharing of the child’s supplement. Stimulation: The objectives of the stimulation intervention were to increase the mother’s ability to promote her child’s development through play, to improve mother-child interaction, and to promote the self-esteem of both mother and child. At the weekly visit, the CHWs demonstrated play techniques and involved the mother in a play session with her child. Mothers were encouraged to continue play activities between the visits and to integrate them into their daily routines. Emphasis was placed on language, the use of praise and positive reinforcement, and physical punishment was discouraged. Toys made from commonly discarded household materials and simple picture books were left in the home and exchanged each week. Control: No treatment - access to free health care only (see below) Supervisors monitored the quality of visits for all groups. All groups were visited weekly by a community health worker (CHW) for two years and were provided free health care (in addition to routinely available primary healthcare) |
| Intervention type | Mixed |
| Primary outcome measure | Child development measured with the Griffiths Scales of mental development on enrollment at age 9-24 months and every 6 months for two years. Overall developmental quotient and 4 subscales |
| Secondary outcome measures | 1. Growth measured using standard anthropometry (height, weight, head circumference, triceps and subscapular skinfold) on enrolment and every 6 months for 2 years 2. Home stimulation measured with HOME (home observation for measurement of the environment) on enrolment and at the end of the trial (24 months later) 3. Morbidity measured by maternal recall weekly for 2 years |
| Overall study start date | 06/01/1986 |
| Completion date | 13/11/1989 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 9 Months |
| Upper age limit | 24 Months |
| Sex | Both |
| Target number of participants | 128 |
| Key inclusion criteria | 1. Height-for-age below -2SD of NCHS reference values 2. Age 9-24 months 3. Weight-for-height below median of NCHS reference values 4. Standard of housing and maternal education below defined levels |
| Key exclusion criteria | 1. Twins 2. Birth weight equal to or below 1.8 kg 3. Significant mental or physical disability |
| Date of first enrolment | 06/01/1987 |
| Date of final enrolment | 11/11/1987 |
Locations
Countries of recruitment
- Jamaica
Study participating centre
Kingston
7
Jamaica
Sponsor information
University/education
Regional Headquarters
Hermitage Road
Kingston
7
Jamaica
| Phone | +876 (0)9272471 |
|---|---|
| caihr@uwimona.edu.jm | |
| Website | mona.uwi.edu |
"ROR" |
https://ror.org/03fkc8c64 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Ford Foundation Center for Social Justice, Ford, FF
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/07/1991 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Study results were published in peer-reviewed journals and presented at international conferences |
| IPD sharing plan | The data is part of ongoing longitudinal research and participant-level data from the trial is not generally available. The data is held at the Caribbean Institute for Health Research |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/07/1991 | 06/12/2019 | Yes | No |
| Results article | results | 01/10/1991 | 06/12/2019 | Yes | No |
| Results article | results | 01/01/1993 | 06/12/2019 | Yes | No |
Editorial Notes
20/01/2020: Trial's existence confirmed by published results papers.
