HIV (Human Immunodeficiency Virus), Malnutrition
Conditions
Keywords
HIV, Malnutrition, Cassava-simsim granules, Nutrition education, Nutritional status, Kenya
Brief summary
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.
Detailed description
Undernutrition remains a critical challenge among people living with HIV (PLWHIV) in Sub-Saharan Africa, contributing to high morbidity and mortality despite access to antiretroviral therapy. Globally, approximately 1.8 billion PLWHIV are affected by undernutrition. HIV infection and nutritional deficiencies increase nutrient requirements, impaired intake, and reduce nutrient utilization, causing weight loss and micronutrient deficiencies. Kisumu County has the second-highest HIV prevalence in the country. Kisumu West Sub-County serves a large population of PLWHIV in a resource-limited setting, where access to adequate nutrition remains a major challenge. This study evaluated the impact of cassava-simsim granules and nutrition education on the nutritional status of HIV seropositive adults in Kisumu West Sub-County, Kenya. Specific objectives were to assess nutritional status and nutrient intake of participants, determine nutrient levels, microbial load, and acceptability of cassava -simsim granules. A quasi-experimental design was adopted. Sample size was determined using a statistical formula by Bolarinwa (2020). A total of 64 moderately malnourished HIV-seropositive adults (BMI of \> 16 kg/m2 - \< 18.5 kg/m2) aged 19 -50 years were enrolled, with 52 completing the 16-week intervention. Participants were purposively allocated to either intervention group (n = 32), which received cassava-simsim granules 230g/day plus nutrition education, or the control group (n = 32), which received nutrition education alone. Data on nutritional status, nutrient intake, and product acceptability were collected using a questionnaire. Serum iron, zinc, and selenium levels and nutrient levels in the product were analyzed using flame atomic absorption spectroscopy (FAAS). Microbial load was determined using a conventional method, and sensory acceptability was evaluated using a 5-point hedonic scale. Nutrient intakes were analyzed in the NutriSurvey software. Data analysis included descriptive statistics, paired sample t-test, independent t-test, one-sample t-test, and analysis of covariance (ANCOVA).
Interventions
DIETARY_SUPPLEMENTArm1 - Cassava root and (sesame) simsim seed granules
cassava-simsim granules
BEHAVIORALNutrition education
Structured nutrition education
Sponsors
Maseno University
National Institute of Mental Health (NIMH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This was a quasi-experimental study, non-randomized parallel. Participants were assigned to either an intervention group receiving cassava root and simsim seed granules combined with nutrition education or to the control group receiving nutrition education only; both groups were on regular diets. baseline and post intervention data were collected. The outcome was compared between the two groups after a 16-week study period. All participants were dewormed at the beginning of the study and those who were to test positive for malaria were to be treated, however none of the participants tested positive for malaria.
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum iron levels | Baseline and week 16 | Serum iron concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status. |
| Serum zinc levels | Baseline and week 16 | Serum zinc concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status. |
| Serum selenium levels | Baseline and week 16 | Serum selenium concentration (µg/L) measured in HIV-seropositive adults as indicator of micronutrient status. |
| Body mass Index (kg/m2) | Baseline and week 16 | Calculated using measured weight (kg) and height (m) to determine nutritional status of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meal Frequency | Baseline and week 16 | Number of meals consumed per day among HIV-positive adults, used to assess dietary intake pattern |
| Dietary Diversity | Baseline and Week 16 | Variety of foods groups consumed by HIV-positive adults, assessed using dietary diversity score based on 10 food group classification |
| Food Quantity Intake | Baseline and week 16 | Quantity of food consumed by HIV-positive adults, assessed in (grams) consumed per day to evaluate dietary intake levels. |
| Vegetable Preparation Methods | Baseline and week 16 | Methods used in vegetable preparation among HIV-positive adults, including steaming, boiling and draining water, boiling and not draining water. |
| Cassava root -simsim seed granules consumption | Baseline and week 16 | Daily consumption of cassava root-simsim seed food-based product among HIV-positive adults as part of the dietary intervention. |
Countries
Kenya
Contacts
PRINCIPAL_INVESTIGATORFlorence F Habwe, PhD
Maseno University
Outcome results
None listed