Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/09/2018
Date assigned
29/10/2018
Last edited
02/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Action against Hunger (ACH) is an international humanitarian organization that fights against the causes and effects of hunger. We save lives of malnourished children and guarantee families access to safe water, food, training and basic health care. The SAM Photo Diagnosis App® project has developed an innovative easy-to-use smartphone tool which can quick and accurately diagnose nutritional status in children aged 6-59 months by means of a photo (body shape analysis). Our innovation responds to the need to improve screening, diagnosis and management of malnutrition, providing a unique opportunity to address it at scale at community level.
Despite significant progress over recent decades, maternal and child undernutrition remains a significant problem throughout the developing world, with 45% of deaths of children younger than five years old attributed to malnutrition. Acute malnutrition (wasting) in children is the life-threatening result of hunger and/or disease. Children suffering from acute malnutrition face an increased risk of morbidity and mortality, and therefore require urgent treatment to survive. In 2016, over 52 million children under five years of age suffered from acute malnutrition, with almost 17 million of these children experiencing the most severe form. Only 3.2 million children were successfully diagnosed and treated in 2016, leaving over 80% of children in need but unable to access treatment. It is important that health centres are equipped with the tools and expertise they need to be able to diagnose and manage cases of acute malnutrition. By the same token, it’s important that caretakers are also empowered to continue the treatment and regularly monitor the condition until the child is fully recovered.
Historically, two methods of anthropological measurement have been used for the diagnosis of moderate and severe acute malnutrition – weight-for-height (WHZ) and mid-upper arm circumference (MUAC). While these techniques provide an accurate diagnosis of acute malnutrition, there are still significant operational challenges for their use at scale. We have demonstrated that image-based techniques can be applied as an alternative diagnosis approach.
This project reinforces decentralization and sustainability of community management of malnutrition by empowering caretakers to diagnose and monitor the nutrition status of their children. It also presents a great opportunity for governments and local health systems to revolutionize nutrition assessments and improve the impact and coverage of nutrition programs.

Who can participate?
Children aged 6-59 months with severe acute malnutrition

What does the study involve?
Phase 1 is the pilot phase. This phase is complete and involved developing an innovative smartphone tool which could quick and accurately diagnose nutritional status, by analysing the child’s body shape registered in photos taken by the device. The development of the algorithm required taking photographs of a sample of well-nourished children in Spain and well-nourished and malnourished children in Senegal. The sample was composed of 107 Spanish children, 154 Senegalese well-nourished children and 142 Senegalese children with severe acute malnutrition. Overall, the Phase 1 project collected over 2,060 images across the sample of children in the study. These images captured the full body photos in different views and allowed the study of both the whole body and split body regions. These images provided the information needed to generate the templates used for diagnosis.
Phase 2 involves adapting the technology to the users. Here the aim is to reinforce both dimensions of the App as a research and diagnostic tool. At conception, it was recognised that a second phase of the project would be needed to further develop the tool and expand its use to different contexts and explore further use of the tool at scale. Thus, as both the programming of the App and the first preliminary results were being generated, new research questions and concerns were arising and opening-up potential future App functionality and usability paths to be developed.
Phase 3 will be a scaling up phase and is currently under development.

What are the possible benefits and risks of participating?
Both Spanish and Senegalese children receive a personalised report (written for Spanish children and both written and/or oral for Senegalese children) regarding their nutritional status, as well as important information related to health and nutrition care practices. All malnutrition diagnosis (both under and overnutrition) are reported directly to the families, informing them of next steps. In Senegal, when a MAM or SAM child is identified, they are immediately referred to the health system. All participants families are informed of the associated technology that was going to be created and the important role they were carrying out for that population in risk or suffering malnutrition by allowing their children to participate. They are also informed that such technology would be available for free in the near future for everyone who wishes to use it.
However, the possible risk is that children do not always wish to participate, even if their parents do, especially babies. Children may get tired during the sampling process.

Where is the study run from?
Action against Hunger (Spain)

When is the study starting and how long is it expected to run for?
November 2015 to June 2020

Who is funding the study?
1. Children's Investment Fund Foundation (UK)
2. World Food Programme (Italy)

Who is the main contact?
Laura Medialdea Marcos
lmedialdea@accioncontraelhambre.org

Trial website

Contact information

Type

Scientific

Primary contact

Ms Laura Medialdea

ORCID ID

Contact details

C/ Duque de Sevilla
3
Madrid
28003
Spain
+34913915300, ext. 1345
lmedialdea@achesp.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ES/SAMphotoD/01

Study information

Scientific title

Severe Acute Malnutrition (SAM) Photo Diagnosis Application Project for nutritional assesment

Acronym

SAMphotoD

Study hypothesis

The starting hypothesis this project was that it is possible to develop an innovative smartphone tool which can quick and accurately diagnose nutritional status, by analysing morphometrically the child’s body shape, registered in photos taken by the device.
Once this hypothesis was verified, a second phase of the project was designed in order to answer the following hypotheses:
1. Shape variations between this two-extreme nutritional status are also measurable if considering Moderate Acute Malnutrition (MAM) and underweight
2. Children’s body shape with SAM present homogeneous growth and body shape pattern among populations with different contexts and culture
3. Chronic malnutrition approach is possible using SAM Photo Diagnosis® methodology
4. A user centred design is possible for addressing community management of malnutrition

Ethics approval

1. Clinical Research Ethical Committee, San Carlos Clinical Hospital, Madrid, Spain, 15/01/2016, reference number: C.P. CMAM 2.0 - C.I. 16/013-E
2. National Ethics Committee for Health Research, Dakar, Senegal, 23/11/2016, reference number: SEN16/35

Study design

Observational epidemiological study with pilot phase and validation phase

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

See additional files (available in Spanish and French)

Condition

Acute and chronic malnutrition in children

Intervention

Phase I of this study was the pilot phase, with the following objectives:
1. Validate geometric morphometric (GM) techniques for use in children under 5 years of age
2. Validate the use of a morphometric model to diagnose severe acute malnutrition (SAM) is a high-prevalence context
3. Document the lessons and knowledge on the application and its use as a diagnostic tool to inform future operational and research use
The development of the algorithm required taking photographs of a sample of well-nourished children in Spain and well-nourished and malnourished children in Senegal. Overall, 2,060 images were collected across the sample of children in the study. These images captured the full body photos in different views and allowed the study of both the whole body and split body regions. These images provided the information needed to generate the templates used for diagnosis. According to bioethical considerations as well as personal data protection policies (Senegalese 2008/12 and European GDPR 16/679), all health data, including images, were treated under a high-level data protection framework. Furthermore, required ethical clearances and consent forms were obtained prior to data collection. Regarding the app development, since the images of body regions are used to diagnose malnutrition with SAM Photo Diagnosis App®, children will not be identifiable from the photos taken and all images will be deleted from mobile devices once the diagnosis has been provided.

Phase II is the validation phase, with the following objectives:
1. Technical validation of SAM Photo Diagnosis App in two selected pilot countries, Senegal and the Democratic Republic of the Congo
2. Creation of a platform where SAM Photo Diagnosis App(R) is integrated integration for holistic community-based management of malnutrition
3. Integration of machine learning technology to allow automated diagnosis of malnutrition
4. Validation of the approach in pilot countries
Pictures of body regions were taken with SAM Photo Diagnosis App(R), and the same ethical considerations applied in Phase I were applied to Phase II. Surveys were conducted to assess nutritional, familiar and context information related to undernutrition and provide useful information for final users.

Phase III is the scaling up phase and has not yet been designed.

Intervention type

Device

Phase

Drug names

Primary outcome measure

1. Anthropometric measurements, taken during phase I of the study:
1.1. Weight (kg), assessed using a portable electronic scale
1.2. Height (cm), assessed using:
1.2.1. Portable infantometer for children under 87 cm
1.2.2. Anthropometer GPM for children over 87 cm
1.3. Mid-upper arm circumference (cm), assessed using a self-rectracting flat metal tape with a blank lead-in strip
1.4. Sitting height (cm), assessed using:
1.4.1. Portable infantometer for children under 87 cm
1.4.2. Anthropometer GPM for children over 87 cm
1.5. Cephalic perimeter (cm), assessed using a self-rectracting flat metal tape with a blank lead-in strip
2. Determination of which photographic angles would provide better image information regarding body shape, assessed through anatomically identifying and marking 68 points on the child's body and analysing the images. This was done during phase I of the study
3. Information regarding the health, nutrition and origin of the child participating in the study, assessed using a survey completed by the parents at the point of photographs being taken (during phase I)

Secondary outcome measures

N/A

Overall trial start date

16/11/2015

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 6-59 months
2. Normal weight: p30 - p70 weight-for-height Z-score (WHZ) or mid-upper arm circumference Z-score (MUACZ)
3. Severe acute malnourishment (WHZ and MUACZ <-3 SD

Participant type

Mixed

Age group

Child

Gender

Both

Target number of participants

Minimum 450. 2 countries (150 Spain, 300 Senegal), nutritional status (normalweight: 150 Spanish, 150 Senegalese; SAM: 150 Senegalese), 2 sexes (50% each group), 2 age groups (50% each group)

Participant exclusion criteria

1. No signed consent
2. Unwilling to participate
3. Health complications
4. Morphological abnormalities

Recruitment start date

01/02/2016

Recruitment end date

20/05/2017

Locations

Countries of recruitment

Senegal, Spain

Trial participating centre

Action against Hunger HQ in Madrid, Complutense University of Madrid, schools and nurseries in Madrid, Casse de tous petites in Senegal
AAH, HQ Madrid: C/ Duque de Sevilla 3
Madrid
28003
Spain

Trial participating centre

CEIP San Juan Bautista
Calle Sorzano 1
Madrid
28043
Spain

Trial participating centre

CEIP Amorós
Calle Gómez de Arteche 31
Madrid
28044
Spain

Trial participating centre

CEIP Lorenzo Luzuriaga
Calle Valencia de Don Juan 19
Madrid
28034
Spain

Trial participating centre

Guardería Cuatro Pecas
Calle Capitán Salazar Martínez 9
Madrid
28005
Spain

Trial participating centre

Guardería Escuela el Girasol
Calle del General Aranaz 54
Madrid
28027
Spain

Trial participating centre

Guardería Coco
Calle de Monseñor Oscar Romero 72
Madrid
28025
Spain

Trial participating centre

Guardería Diabolo
Calle de Cáceres 8
Madrid
28045
Spain

Trial participating centre

Guardería EL Arlequín
Calle los Yébenes 69
Madrid
28047
Spain

Trial participating centre

Guardería el Arullo
Calle de Montes de Barbanza
Madrid
28031
Spain

Trial participating centre

Guardería Los Nanos Chiflados
Calle de Marcenado 46
Madrid
28002
Spain

Trial participating centre

Universidad Complutense de Madrid
Av. Séneca 2
Madrid
28040
Spain

Trial participating centre

Diela
Kanel Matam
Diela
N/A
Senegal

Trial participating centre

CTP - Kanel
Kanel Matam
N/A
Senegal

Trial participating centre

Danthiady
Kanel Matam
N/A
Senegal

Trial participating centre

Douloul
Kanel Matam
N/A
Senegal

Trial participating centre

Orndolde
Kanel Matam
N/A
Senegal

Trial participating centre

Ounare
Kanel Matam
N/A
Senegal

Trial participating centre

Polel Diaoube
Kanel Matam
N/A
Senegal

Trial participating centre

Sinthiou Bamambe
Kanel Matam
N/A
Senegal

Trial participating centre

Sinthiou Garba
Kanel Matam
N/A
Senegal

Trial participating centre

Wodaberé
Kanel Matam
N/A
Senegal

Trial participating centre

Younouferé
Kanel Matam
N/A
Senegal

Trial participating centre

Bockisabundu
Matam Matam
N/A
Senegal

Trial participating centre

Boinadji
Matam Matam
N/A
Senegal

Trial participating centre

CTP - Matam
Matam Matam
N/A
Senegal

Trial participating centre

CTP - Sedo Sebe
Matam Matam
N/A
Senegal

Trial participating centre

CTP Fété Niébé
Matam Matam
N/A
Senegal

Trial participating centre

Diamel
Matam Matam
N/A
Senegal

Trial participating centre

Maternelle - Gourel Sérigne
Matam Matam
N/A
Senegal

Trial participating centre

Maternelle - Matam 1
Matam Matam
N/A
Senegal

Trial participating centre

Maternelle - Ndouloumadji
Matam Matam
N/A
Senegal

Trial participating centre

Ogo
Matam Matam
N/A
Senegal

Trial participating centre

Ourossogui
Matam Matam
N/A
Senegal

Trial participating centre

Soubalo
Matam Matam
N/A
Senegal

Trial participating centre

Badagor
Ranerou Matam
N/A
Senegal

Trial participating centre

CTP - Ranerou
Ranerou Matam
N/A
Senegal

Trial participating centre

Fourdou
Ranerou Matam
N/A
Senegal

Trial participating centre

Lougueré Thiolly
Ranerou Matam
N/A
Senegal

Trial participating centre

Loumbol Samba Abdoul
Ranerou Matam
N/A
Senegal

Trial participating centre

Mbem mbem
Ranerou Matam
N/A
Senegal

Trial participating centre

Nawré
Ranerou Matam
N/A
Senegal

Trial participating centre

Salalatou
Ranerou Matam
N/A
Senegal

Trial participating centre

Thionokh
Ranerou Matam
N/A
Senegal

Trial participating centre

Velingara
Ranerou Matam
N/A
Senegal

Trial participating centre

Guardería Projardín Praga
Calle de Antonio López 67
Madrid
28019
Spain

Trial participating centre

Guardería Projardín Delicias
Paseo de las Delicias 65
Madrid
28045
Spain

Sponsor information

Organisation

Childs Investment Fund Foundaion (CIFF)

Sponsor details

7 Clifford Street
London
W1S 2FT
United Kingdom

Sponsor type

Charity

Website

https://ciff.org/

Funders

Funder type

Not defined

Funder name

Children's Investment Fund Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Food Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We have produced a promotional video of the project (https://www.youtube.com/watch?v=y0VlLxYKpZY&feature=youtu.be) and a general diffusion article (https://www.ennonline.net//fex/57/samphotodiagnosisapp).
A manuscript is under review with the American Journal of Physical Anthropology.
We aim to prepare another two manuscripts to be sent to peer-reviewed journals in December 2018 and March 2019

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/01/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/04/2019: The participant information sheet has been uploaded.