Evaluation of a Rwanda Hospital Feeding Program on Nutrition, Recovery, Costs of Care and Health Related Quality of Life

February 25, 2025 updated by: Stefanie Weiland, Solid'Africa

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
794

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Butare, Rwanda
        • Centre Hopitalier Universitaire de Butare
      • Kigali, Rwanda
        • Centre Hopitalier Universitaire de Kigali
      • Kigali, Rwanda
        • Masaka Hospital
      • Nyamata, Rwanda
        • Nyamata Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gemura
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.
Other: Meals
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.
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and final day of patient stay, on average day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: Baseline and final day of patient stay, on average day 5
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.
Baseline and final day of patient stay, on average day 5
Treatment outcome
Time Frame: Final day of patient stay, on average day 5
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.
Final day of patient stay, on average day 5
Costs of treatment
Time Frame: Final day of patient stay, on average day 5
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.
Final day of patient stay, on average day 5
Patient satisfaction
Time Frame: Final day of patient stay, on average day 5
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.
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
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').
Final day of patient stay, on average day 5

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Food intake
Time Frame: Daily until final day of patient stay, about every 24 hours for 5 days on average
In addition to nutritional status, the study will measure food intake as a patient-reported intermediate outcome measure. Trained research assistants will survey enrolled patients daily to measure estimated quantity, content, and frequency of food intake as well as a comparison to food intake at home. The food intake surveys will also provide additional qualitative data that will be used for thematic analysis and interpretation of other outcomes.
Daily until final day of patient stay, about every 24 hours for 5 days on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Solid'Africa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefanie Weiland, MSc MPH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNEC80/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IDP may be shared upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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