- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07620197
Income Generation, Food and Nutrient Security for Improved Livelihoods and Health Outcomes Among HIV-Positive, Kenya
A Quasi-experimental Design of Income Generation, Food and Nutrient Security for Improved Livelihoods and Health Outcomes Among People Living With HIV (PLWHIV), Kenya
The goal of this trial is to evaluate whether cassava root and sesame seed granules combined with nutrition education can improve the nutritional status of HIV-seropositive adults. People living with HIV face food insecurity, and HIV also increases nutrient requirements and reduces nutrient intake, leading to weight loss, underweight, and impaired immune function, which worsens the situation, leading to increased deaths. The main question was:
Does improving food and nutrient security improve the livelihoods and health outcomes among people living with HIV Researchers compared cassava root and sesame (simsim) seed granules combined with nutrition education to nutrition education alone to see if it works to improve the nutritional status of HIV-positive underweight adults.
- Participants received 230g of cassava root-simsim seed granules daily, and one session of structured individual nutrition education monthly during every visit to the hospital, totaling to 5 sessions during the 16-week study period
- Participants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period
- Participants visited the hospital monthly for resupply and nutrition education
- They brought back any unused granules during hospital visits.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Kisumu, Kenya, 40105
- Chulaimbo County Hospital
-
Kisumu, Kenya, 40105
- Nyahera Sub County Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- HIV-seropositive adults aged 19 - 50 years
- Enrolled at the two study sites
- willing to consent to participate in the study
- Body Mass Index (BMI) of > 16 kg/m2 - < 18.5 kg/m2
- Hemoglobin levels 8g/dL - 12g/dL for non-pregnant women
- Hemoglobin levels 8g/dL - 13 g/dL for men
Exclusion Criteria:
- Severe acute malnutrition BMI of < 16 kg/m2
- Hemoglobin levels of < 8 g/dL
- Chronic conditions
- Pregnant mothers
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition education
Participants received one serving of cassava root-simsim seed granules daily, each 230g, and one session of structured individual nutrition education monthly during every visit to the facility totaling to 5 sessions during the study period
|
cassava-simsim granules
Structured nutrition education
|
|
Aktiv komparator: Arm 2 - Nutrition education
Participants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period
|
Structured nutrition education
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum iron levels
Tidsramme: Baseline and week 16
|
Serum iron concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
|
Baseline and week 16
|
|
Serum zinc levels
Tidsramme: Baseline and week 16
|
Serum zinc concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
|
Baseline and week 16
|
|
Serum selenium levels
Tidsramme: Baseline and week 16
|
Serum selenium concentration (µg/L) measured in HIV-seropositive adults as indicator of micronutrient status.
|
Baseline and week 16
|
|
Body mass Index (kg/m2)
Tidsramme: Baseline and week 16
|
Calculated using measured weight (kg) and height (m) to determine nutritional status of participants
|
Baseline and week 16
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Meal Frequency
Tidsramme: Baseline and week 16
|
Number of meals consumed per day among HIV-positive adults, used to assess dietary intake pattern
|
Baseline and week 16
|
|
Dietary Diversity
Tidsramme: Baseline and Week 16
|
Variety of foods groups consumed by HIV-positive adults, assessed using dietary diversity score based on 10 food group classification
|
Baseline and Week 16
|
|
Food Quantity Intake
Tidsramme: Baseline and week 16
|
Quantity of food consumed by HIV-positive adults, assessed in (grams) consumed per day to evaluate dietary intake levels.
|
Baseline and week 16
|
|
Vegetable Preparation Methods
Tidsramme: Baseline and week 16
|
Methods used in vegetable preparation among HIV-positive adults, including steaming, boiling and draining water, boiling and not draining water.
|
Baseline and week 16
|
|
Cassava root -simsim seed granules consumption
Tidsramme: Baseline and week 16
|
Daily consumption of cassava root-simsim seed food-based product among HIV-positive adults as part of the dietary intervention.
|
Baseline and week 16
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Florence F Habwe, PhD, Maseno University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Urogenitale sygdomme
- Genitale sygdomme
- Ernæringsforstyrrelser
- Sygdomme i immunsystemet
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Langsomme virussygdomme
- HIV-infektioner
- Ernæringsmæssige og metaboliske sygdomme
- Fejlernæring
- Erhvervet immundefektsyndrom
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Epidemiologiske målinger
- Ernæringsvurdering
Andre undersøgelses-id-numre
- MSU/DRPI/MUSERC/01295/23
- 1R01MH107330 (U.S. NIH-bevilling/kontrakt)
- NACOSTI/P/24/32560 (Anden identifikator: National Commission for Science, Technology & Innovation)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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