Infant anthropometry and body composition in Ethiopia
| ISRCTN | ISRCTN46718296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46718296 |
| Protocol serial number | N/A |
| Sponsor | University of Copenhagen (Denmark) |
| Funders | Danida (Denmark), University of Copenhagen (Denmark) - Faculty of Life Sciences |
- Submission date
- 08/12/2010
- Registration date
- 10/01/2011
- Last edited
- 11/03/2024
- 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
Contact information
Prof Henrik Friis
Scientific
Scientific
University of Copenhagen
Department of Human Nutrition
Rolighedsvej 30
Frederiksberg C.
1958
Denmark
| hfr@life.ku.dk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study with nested cross-sectional study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Predictors of neonatal and early infant body composition and growth and its effect on health in Jimma, Ethiopia: an observational study of infant body composition using infant air displacement plethysmography |
| Study acronym | iABC |
| Study objectives | The rationale for the study is that little is known about fat and lean mass development in foetal and early life, in particular in the studies population. Answering the following questions will provide new understanding of body composition in early life: 1. What are the fat and lean mass levels at birth? 2. Which maternal and infant factors predict neonatal body composition? 3. Which maternal and infant factors - including birth weight - predict changes in fat and lean mass from 0 to 6 months? 4. What is the relationship between birth weight and 6 month body composition? 5. What is the relationship between neonatal body composition and infant morbidity and growth? |
| Ethics approval(s) | 1. Jimma University Ethical Review Committee approved on the 23rd December 2008 (ref: RPO/56/2001) (Air Displacement Plethysmography Study) 2. Jimma University Ethical Review Committee approved on the 12th October 2009 (ref: RPGC/J05/2002) (Deuterium Dilution substudy) N.B. The reference numbers are based on the Ethiopian calendar, which is approximately 8 years behind the Gregorian calendar |
| Health condition(s) or problem(s) studied | Neonatal and infant fat and lean mass |
| Intervention | Neonatal and infant body composition is measured using infant air displacement plethysmography (PeaPod, Life Measurement, Inc). On a subsample of 120 individuals infant body composition is measured using deuterium dilution. Maternal body composition is measured using bio-impedance analysis (BC-418MA, Tanita B.V.). Anthropometry are measured using conventional methods, and questionnaire information is taken orally in local language. The duration of the study is 6 months, as newborns and mothers are assessed 6 times: at birth, 6, 10, 14, 18 and 26 weeks of age. Duration of follow-up is also 6 months. Contact details for Ethiopian Principal Investigator: Dr Tsinuel Girma Department of Pediatrics and Child Health PO Box 574 Jimma Ethiopia |
| Intervention type | Other |
| Primary outcome measure(s) |
Fat and lean mass at birth, 6-, 10-, 14-, 18- and 26 weeks of age, measured with infant air displacement plethymography and deuterium dilution (in a sub-sample) |
| Key secondary outcome measure(s) |
Anthropometry and self-reported (by the mother) morbidity at birth, 6-, 10-, 14-, 18- and 26 weeks of age |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 15 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 350 |
| Total final enrolment | 378 |
| Key inclusion criteria | 1. Pregnant mother aged between 15 - 45 years 2. Currently living in Jimma town 3. Planning to stay in Jimma town for at least 6 months after birth 4. Consent is given 5. Children are between 0 - 6 months of age |
| Key exclusion criteria | 1. Birth weight less than 1500 g 2. Congenital malformation |
| Date of first enrolment | 17/12/2008 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- Denmark
- Ethiopia
Study participating centre
University of Copenhagen
Frederiksberg C.
1958
Denmark
1958
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No | |
| Results article | results | 01/10/2019 | 21/06/2019 | Yes | No |
| Results article | results | 01/11/2019 | 12/09/2019 | Yes | No |
| Results article | results | 01/07/2018 | 17/09/2019 | Yes | No |
| Results article | 14/06/2023 | 19/06/2023 | Yes | No | |
| Results article | 06/03/2024 | 11/03/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/03/2024: Publication reference added.
19/06/2023: Publication reference added.
17/09/2019: Publication reference added.
12/09/2019: Publication reference and total final enrolment added.
21/06/2019: Publication reference added.
