NutritionNCT06852885
Evaluation of a Rwanda Hospital Feeding Program on Nutrition, Recovery, Costs of Care and Health Related Quality of Life
A study testing Meals in people with Nutrition, run by Solid'Africa at 4 sites in Rwanda.
Trial summary
The purpose of this interventional study was to evaluate outcomes for Solid'Africa's Gemura feeding program in four selected public hospitals comparing results between patients receiving and patients not receiving the feeding program. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Nutrition
- What is being tested?
- Meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 794 participants
- Where
- 4 sitesRwanda
- Study dates
- 28 May 2024to 14 Oct 2024
- Phase
- Interventional
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospital inpatients
- Vulnerable socioeconomic status according to social worker assessment
- Most inpatient categories
- Voluntary, self-feeding ability
- Able to stand on scale, with help if needed
Who cannot join
- Hospital outpatients
- Patients not determined socioeconomically vulnerable by social worker
- Pregnant women hospitalized for delivery
- Patients undergoing special treatment for malnutrition
- Patients receiving enteral or parenteral nutrition treatment
- Patients receiving any kind of artificial feeding support
- Patients unable to stand on scale to measure weight
Trial locations and contacts
4 sites in 1 country.
Rwanda4 sites
Centre Hopitalier Universitaire de Butare
Butare
Centre Hopitalier Universitaire de Kigali
Kigali
Masaka Hospital
Kigali
Nyamata Hospital
Nyamata
About this study
Official title: Evaluation of a Food Access Program on Inpatient Nutrition, Recovery, Cost of Care, and Health Related Quality of Life in Selected Public Hospitals in Rwanda
The purpose of this interventional study was to evaluate outcomes for Solid'Africa's Gemura feeding program in four selected public hospitals comparing results between patients receiving and patients not receiving the feeding program. The study measured the effects of the program on patients nutritional status, recovery during hospitalization, patient health related-quality of life, patient satisfaction, and patient costs of care. Participants were asked: (1) to eat meals provided three times a day if they were in the intervention group; (2) to participate in an intake and discharge survey; and (3) to participate in a daily food intake survey.
Read the detailed description
A multi-center, quasi-experimental study using difference-in-differences controlled comparison to test the outcomes of Solid'Africa's Gemura feeding intervention in four selected public hospitals (two in intervention group and other two in control group) from urban and peri-urban areas targeting socioeconomically vulnerable inpatients. This study has a primary outcome which is nutritional status as measured by body mass index (BMI), and secondary outcomes which include recovery during hospitalization, patient health-related quality of life (HRQOL), patient satisfaction, and patient costs of care.
- Conditions
- Nutrition
- Being tested
- Meals
- Keywords
- Nutrition, hospitals, public, malnutrition, sub-Saharan Africa, food intake
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealsOther
The intervention of the Solid'Africa Gemura selective feeding program will be administered as usual for study participants in the two intervention sites. Eligible hospital inpatients will receive three meals a day during their hospital stay, as prescribed by hospital nutritionists for their specific conditions and ordered from Solid'Africa. The Solid'Africa team will prepare the ordered meals in their off-site kitchen in Rusororo and deliver them daily to the hospitals where the meals will be distributed to the study participants. Meal caloric and nutritional content information is standardized except upon request. The normal meal is 575g of food consisting of 2300kCal with 300g of carbohydrates, 175g of protein, and 100g vitamins/minerals. In addition, Solid'Africa will adjust meal content per nutritionist request for specific needs like low salt/sugar, etc.
| Study group | Role | What they receive |
|---|---|---|
| Gemura | Experimental | The intervention of the Solid'Africa Gemura selective feeding program will be administered as usual for study participants in the two intervention sites. Eligible hospital inpatients will receive three meals a day during their hospital stay, as prescribed by hospital nutritionists for their specific conditions and ordered from Solid'Africa. The Solid'Africa team will prepare the ordered meals in their off-site kitchen in Rusororo and deliver them daily to the hospitals where the meals will be distributed to the study participants. Meal caloric and nutritional content information is standardized except upon request. The normal meal is 575g of food consisting of 2300kCal with 300g of carbohydrates, 175g of protein, and 100g vitamins/minerals. In addition, Solid'Africa will adjust meal content per nutritionist request for specific needs like low salt/sugar, etc. Receives: Other: Meals |
| Control | No intervention | This arm includes inpatients meeting the same eligibility criteria as the intervention arm. However, no intervention will be offered and these patients will experience a hospital stay as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Nutritional status will be measured anthropometrically in terms of weight-for-height for all participants to calculate body mass index (BMI = kg/m2). Weight will be measured with a digital weight scale and height will be measured in recumbent position for patients unable to stand and in a standing position for other patients using a height board or a tape measure. Nutritional status will also be classified at baseline and at endline, with BMI < 18.5 considered underweight, 18.5-24.9 normal weight, 25.0-29.9 overweight, and 30.0+ obese.49 Underweight will be further classified as standard for adults and for children. For children, chronic malnutrition or stunting (low height for age) and acute malnutrition or wasting (low weight for height) will be defined according to the World Health Organization growth charts and classification standards.
Measured: Baseline and final day of patient stay, on average day 5
Secondary outcomes (5)
Length of Stay
LOS will be measured in days (or fractions thereof) and collected as patient record data from routine data sources, such as patient charts, by trained research assistants.
Measured: Baseline and final day of patient stay, on average day 5
Treatment outcome
Treatment outcome will be measured with a survey tool created to assess completion and outcome of treatment and recovery during the hospitalization period from the perspective of the attending health care worker. Questions on treatment outcome will frame answers on a Likert scale. Additional qualitative questions on treatment outcome from the patients' perspective will be included on the patient discharge survey.
Measured: Final day of patient stay, on average day 5
Costs of treatment
Costs of treatment will be measured in RWF and collected from both heath facility records of patient treatment costs as well as from patients in their discharge survey. Where precise figures are not available or recalled, such as transportation costs, estimates may be made based on available data. Costs will be measured from the patient perspective, but may also include the health service perspective to get a societal perspective.
Measured: Final day of patient stay, on average day 5
Patient satisfaction
Patient satisfaction will be measured with a survey on discharge including one open-ended question on satisfaction and another based on the Net Promoter Score (NPS). NPS has been widely used in business and in healthcare settings, including by the UK National Health Service (NHS). The open-ended survey question with reference to the NHS's most recently updated patient survey guidance.
Measured: Final day of patient stay, on average day 5
Health-related quality of life
Patient health-related quality of life is measured as a patient reported outcome and surveyed using the EuroQol EQ-5D-3L (5 dimension/3 level) health questionnaire. This standardized measure of health-related quality of life developed by the EuroQol Group is a simple, generic questionnaire for use in clinical and economic appraisal or population health status surveys. Respondents answer "no/some/extreme problems" to questions in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It is a point-in-time survey and was administered by trained research assistants to participants at discharge. The Kinyarwanda version is provided by EuroQol. Part 2 is a standard vertical 20 cm visual analogue scale, used in recording an individual's rating of their overall current health-related quality of life. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state').
Measured: Final day of patient stay, on average day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start28 May 2024
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 794 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solid'Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanie Weiland, Solid'Africa
- Investigators
- Stefanie Weiland, MSc MPH, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852885
- Sponsor's protocol ID
- RNEC80/2024
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP may be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Food Access Program on Inpatient Nutrition, Recovery, Cost of Care, and Health Related Quality of Life in Selected Public Hospitals in Rwanda
- ClinicalTrials.gov ID
- NCT06852885
- Acronym / sponsor ID
- RNEC80/2024
- Conditions
- Nutrition
- Keywords
- Nutrition, hospitals, public, malnutrition, sub-Saharan Africa, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 794 participants (actual)
- Lead sponsor
- Solid'AfricaUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 28 Feb 2025 (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.
The purpose of this interventional study was to evaluate outcomes for Solid'Africa's Gemura feeding program in four selected public hospitals comparing results between patients receiving and patients not receiving the feeding program. The study measured the effects of the program on patients nutritional status, recovery during hospitalization, patient health related-quality of life, patient satisfaction, and patient costs of care. Participants were asked: (1) to eat meals provided three times a day if they were in the intervention group; (2) to participate in an intake and discharge survey; and (3) to participate in a daily food intake survey.
Detailed description
A multi-center, quasi-experimental study using difference-in-differences controlled comparison to test the outcomes of Solid'Africa's Gemura feeding intervention in four selected public hospitals (two in intervention group and other two in control group) from urban and peri-urban areas targeting socioeconomically vulnerable inpatients. This study has a primary outcome which is nutritional status as measured by body mass index (BMI), and secondary outcomes which include recovery during hospitalization, patient health-related quality of life (HRQOL), patient satisfaction, and patient costs of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemura | Experimental | Other: MealsThe intervention of the Solid'Africa Gemura selective feeding program will be administered as usual for study participants in the two intervention sites. Eligible hospital inpatients will receive three meals a day during their hospital stay, as prescribed by hospital nutritionists for their specific conditions and ordered from Solid'Africa. The Solid'Africa team will prepare the ordered meals in their off-site kitchen in Rusororo and deliver them daily to the hospitals where the meals will be distributed to the study participants. Meal caloric and nutritional content information is standardized except upon request. The normal meal is 575g of food consisting of 2300kCal with 300g of carbohydrates, 175g of protein, and 100g vitamins/minerals. In addition, Solid'Africa will adjust meal content per nutritionist request for specific needs like low salt/sugar, etc. |
| Control | No intervention | –This arm includes inpatients meeting the same eligibility criteria as the intervention arm. However, no intervention will be offered and these patients will experience a hospital stay as usual. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Hospital inpatients
- Vulnerable socioeconomic status according to social worker assessment
- Most inpatient categories
- Voluntary, self-feeding ability
- Able to stand on scale, with help if needed
Key exclusion criteria (7 listed)
- Hospital outpatients
- Patients not determined socioeconomically vulnerable by social worker
- Pregnant women hospitalized for delivery
- Patients undergoing special treatment for malnutrition
- Patients receiving enteral or parenteral nutrition treatment
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 |
|---|---|---|
| MealsThe intervention of the Solid'Africa Gemura selective feeding program will be administered as usual for study participants in the two intervention sites. Eligible hospital inpatients will receive three meals a day during their hospital stay, as prescribed by hospital nutritionists for their specific conditions and ordered from Solid'Africa. The Solid'Africa team will prepare the ordered meals in their off-site kitchen in Rusororo and deliver them daily to the hospitals where the meals will be distributed to the study participants. Meal caloric and nutritional content information is standardized except upon request. The normal meal is 575g of food consisting of 2300kCal with 300g of carbohydrates, 175g of protein, and 100g vitamins/minerals. In addition, Solid'Africa will adjust meal content per nutritionist request for specific needs like low salt/sugar, etc. | Other | Gemura |
Primary outcome
Nutritional status
Time frame: Baseline and final day of patient stay, on average day 5
Nutritional status will be measured anthropometrically in terms of weight-for-height for all participants to calculate body mass index (BMI = kg/m2). Weight will be measured with a digital weight scale and height will be measured in recumbent position for patients unable to stand and in a standing position for other patients using a height board or a tape measure. Nutritional status will also be classified at baseline and at endline, with BMI < 18.5 considered underweight, 18.5-24.9 normal weight, 25.0-29.9 overweight, and 30.0+ obese.49 Underweight will be further classified as standard for adults and for children. For children, chronic malnutrition or stunting (low height for age) and acute malnutrition or wasting (low weight for height) will be defined according to the World Health Organization growth charts and classification standards.
5 secondary outcomes
Length of Stay
Time frame: Baseline and final day of patient stay, on average day 5
Treatment outcome
Time frame: Final day of patient stay, on average day 5
Costs of treatment
Time frame: Final day of patient stay, on average day 5
Patient satisfaction
Time frame: Final day of patient stay, on average day 5
Health-related quality of life
Time frame: Final day of patient stay, on average day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No. IDP may be shared upon reasonable request.
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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.
Stefanie Weiland, MSc MPH principal investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meals in people with Nutrition, run by Solid'Africa at 4 sites in Rwanda.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Rwanda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status (time frame: Baseline and final day of patient stay, on average day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.