Dietary Intake AssessmentPDIASNCT03723460
Passive Dietary Intake Assessment Study
An observational study of Dietary Intake Assessment and Passive Dietary Monitoring, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Currently, there is no accurate measurement of dietary intake. All current methodologies of assessing dietary intake have inaccuracy rates of 30 -70%. Accurate assessment of dietary intake is critical in understanding individual and population nutritional status and monitoring the effectiveness of public health… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dietary Intake Assessment, Passive Dietary Monitoring, Malnutrition
- What is being tested?
- Passive Dietary Monitoring
- How many people
- 264 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2018to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population comprises of members of households living in rural and urban/per-urban communities in Ghana and Kenya
Who may be able to join
- Household comprising of both parents (mother and father) and at least a child/children under 5 years of age and/or an adolescent child
- Members of the household eat the same prepared meal
- Willingness to use a camera/video recording device to capture household food preparation and consumption.
Who cannot join
- Households not meeting the above inclusion criteria will not be recruited
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London, W120NN
Garry Frost, Prof, 004420 7594 0959, g.frost@imperial.ac.uk
About this study
Official title: Development of a Passive Dietary Monitoring System to Estimate an Individual's Dietary Intake in Households in Low and Middle-income Countries
Currently, there is no accurate measurement of dietary intake. All current methodologies of assessing dietary intake have inaccuracy rates of 30 -70%. Accurate assessment of dietary intake is critical in understanding individual and population nutritional status and monitoring the effectiveness of public health interventions to maintain nutritional health. Estimating dietary intake in low and middle-income countries (LMICs) is remarkably challenging, albeit the high presence of malnutrition and the critical need for evidence-based data to inform policies and programmes on nutrition and health.
This study aims to develop and validate a low-cost and robust system for accurate measurement of an individual's dietary intake in households in LMICs. This innovative system passively recognises food, records intake, and estimates nutrient content of food. The system will be validated in field trials in Ghana and Kenya.
Read the detailed description
This protocol describes the process of developing and validating a passive dietary monitoring system for the assessment of an individual's dietary intake in households in Ghana and Kenya.
The first phase of the study involves preliminary testing of identified dietary monitoring camera/video devices in a lab setting at Imperial College London under conditions similar to those anticipated in Ghana and Kenya. These conditions may include low lighting, unique foods common to certain regions, communal eating (where more than one person eats from a shared plate of cooked food) and placement of the devices on the body. This is important to guide the design of a suitable passive dietary monitoring system.
The second phase of the study involves an in-depth understanding of household set-up, composition and eating behaviour and testing the feasibility and acceptability of using passive dietary monitoring devices/system in communities in Ghana and Kenya. The data gathered in this phase of the study will inform the choice of the passive dietary monitoring system and configuration to use in the field validation study.
Finally, in the validation phase of the study, the passive dietary monitoring system developed will be set up to record food intake and estimate nutrient content of food across 88 households in Ghana and Kenya. In addition, 24h dietary recall (a commonly used method of collecting dietary intake data in population studies) and weighed food records will be used to estimate food intake in the households. The dietary intake data obtained through the passive monitoring system will be compared to 24h dietary recall and weighed food record data to validate its accuracy.
- Being tested
- Passive Dietary Monitoring
- Keywords
- Dietary Intake Assessment, Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Dietary MonitoringOther
Passive dietary monitoring devices will be used to monitor dietary intake in household in communities in Ghana and Kenya
| Study group | Role | What they receive |
|---|---|---|
| Households | Household here means a family unit comprising of at least both parents (mother and father) and a child under 5 years of age or an adolescent child. Receives: Other: Passive Dietary Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Intake Measures
This involves the use of camera/video imaging to estimate food volume/quantity, portion size (amount of ingested food) and nutrient content of food (macro and micronutrient content of food)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start15 Nov 2018
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary Intake AssessmentStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- KEMRI-Wellcome Trust Collaborative Research Program, University of Ghana, University of Pittsburgh, Baylor College of Medicine, University of Alabama at Birmingham, Boston University, University of Colorado, Denver, University of Georgia
- Responsible party
- Sponsor
- Investigators
- Gary Frost, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723460
- Sponsor's protocol ID
- 18IC4780
- Other IDs
- OPP1171395
- Acronym
- PDIAS
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2018
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data will be shared to other researchers through a secure cloud data storage system and through publication in open access journals.
Publications
Jobarteh ML, McCrory MA, Lo B, Sun M, Sazonov E, Anderson AK, Jia W, Maitland K, Qiu J, Steiner-Asiedu M, Higgins JA, Baranowski T, Olupot-Olupot P, Frost G. Development and Validation of an Objective, Passive Dietary Assessment Method for Estimating Food and Nutrient Intake in Households in Low- and Middle-Income Countries: A Study Protocol. Curr Dev Nutr. 2020 Feb 7;4(2):nzaa020. doi: 10.1093/cdn/nzaa020. eCollection 2020 Feb.
PubMed 32099953
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Passive Dietary Monitoring System to Estimate an Individual's Dietary Intake in Households in Low and Middle-income Countries
- ClinicalTrials.gov ID
- NCT03723460
- Acronym / sponsor ID
- PDIAS / 18IC4780
- Keywords
- Dietary Intake Assessment, Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- KEMRI-Wellcome Trust Collaborative Research Program, University of Ghana, University of Pittsburgh, Baylor College of Medicine, University of Alabama at Birmingham, Boston University, University of Colorado, Denver, University of Georgia
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, there is no accurate measurement of dietary intake. All current methodologies of assessing dietary intake have inaccuracy rates of 30 -70%. Accurate assessment of dietary intake is critical in understanding individual and population nutritional status and monitoring the effectiveness of public health interventions to maintain nutritional health. Estimating dietary intake in low and middle-income countries (LMICs) is remarkably challenging, albeit the high presence of malnutrition and the critical need for evidence-based data to inform policies and programmes on nutrition and health.
This study aims to develop and validate a low-cost and robust system for accurate measurement of an individual's dietary intake in households in LMICs. This innovative system passively recognises food, records intake, and estimates nutrient content of food. The system will be validated in field trials in Ghana and Kenya.
Detailed description
This protocol describes the process of developing and validating a passive dietary monitoring system for the assessment of an individual's dietary intake in households in Ghana and Kenya.
The first phase of the study involves preliminary testing of identified dietary monitoring camera/video devices in a lab setting at Imperial College London under conditions similar to those anticipated in Ghana and Kenya. These conditions may include low lighting, unique foods common to certain regions, communal eating (where more than one person eats from a shared plate of cooked food) and placement of the devices on the body. This is important to guide the design of a suitable passive dietary monitoring system.
The second phase of the study involves an in-depth understanding of household set-up, composition and eating behaviour and testing the feasibility and acceptability of using passive dietary monitoring devices/system in communities in Ghana and Kenya. The data gathered in this phase of the study will inform the choice of the passive dietary monitoring system and configuration to use in the field validation study.
Finally, in the validation phase of the study, the passive dietary monitoring system developed will be set up to record food intake and estimate nutrient content of food across 88 households in Ghana and Kenya. In addition, 24h dietary recall (a commonly used method of collecting dietary intake data in population studies) and weighed food records will be used to estimate food intake in the households. The dietary intake data obtained through the passive monitoring system will be compared to 24h dietary recall and weighed food record data to validate its accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Households | – | Other: Passive Dietary MonitoringHousehold here means a family unit comprising of at least both parents (mother and father) and a child under 5 years of age or an adolescent child. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises of members of households living in rural and urban/per-urban communities in Ghana and Kenya
Key inclusion criteria (3 listed)
- Household comprising of both parents (mother and father) and at least a child/children under 5 years of age and/or an adolescent child
- Members of the household eat the same prepared meal
- Willingness to use a camera/video recording device to capture household food preparation and consumption.
Key exclusion criteria (1 listed)
- Households not meeting the above inclusion criteria will not be recruited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Dietary MonitoringPassive dietary monitoring devices will be used to monitor dietary intake in household in communities in Ghana and Kenya | Other | Households |
Primary outcome
Dietary Intake Measures
Time frame: 18 months
This involves the use of camera/video imaging to estimate food volume/quantity, portion size (amount of ingested food) and nutrient content of food (macro and micronutrient content of food)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 32099953Jobarteh ML, McCrory MA, Lo B, Sun M, Sazonov E, Anderson AK, Jia W, Maitland K, Qiu J, Steiner-Asiedu M, Higgins JA, Baranowski T, Olupot-Olupot P, Frost G. Development and Validation of an Objective, Passive Dietary Assessment Method for Estimating Food and Nutrient Intake in Households in Low- and Middle-Income Countries: A Study Protocol. Curr Dev Nutr. 2020 Feb 7;4(2):nzaa020. doi: 10.1093/cdn/nzaa020. eCollection 2020 Feb.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data will be shared to other researchers through a secure cloud data storage system and through publication in open access journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Frost, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Intake Assessment and Passive Dietary Monitoring, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gary Frost, PhD (02083838037, g.frost@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Intake Measures (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03723460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.