NCT06852885

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
794

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

February 20, 2025

Last Update Submit

February 25, 2025

Conditions

Keywords

Nutritionhospitals, publicmalnutritionsub-Saharan Africafood intake

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and final day of patient stay, on average day 5

Secondary Outcomes (5)

  • Length of Stay

    Baseline and final day of patient stay, on average day 5

  • Treatment outcome

    Final day of patient stay, on average day 5

  • Costs of treatment

    Final day of patient stay, on average day 5

  • Patient satisfaction

    Final day of patient stay, on average day 5

  • Health-related quality of life

    Final day of patient stay, on average day 5

Other Outcomes (1)

  • Food intake

    Daily until final day of patient stay, about every 24 hours for 5 days on average

Study Arms (2)

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.

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.

Interventions

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.

Gemura

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hopitalier Universitaire de Butare

Butare, Rwanda

Location

Centre Hopitalier Universitaire de Kigali

Kigali, Rwanda

Location

Masaka Hospital

Kigali, Rwanda

Location

Nyamata Hospital

Nyamata, Rwanda

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Meals

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stefanie Weiland, MSc MPH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 28, 2025

Study Start

May 28, 2024

Primary Completion

October 14, 2024

Study Completion

October 14, 2024

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

IDP may be shared upon reasonable request.

Locations