Income Generation, Food and Nutrient Security for Improved Livelihoods and Health Outcomes Among HIV-Positive, Kenya
2026年5月27日 更新者：Lucia Kaluki Mutwika、Maseno University
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.
調査の概要
状態
完了
詳細な説明
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).
研究の種類
介入
入学 (実際)
64
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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Kisumu、ケニア、40105
- Chulaimbo County Hospital
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Kisumu、ケニア、40105
- Nyahera Sub County Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
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cassava-simsim granules
Structured nutrition education
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アクティブコンパレータ：Arm 2 - Nutrition education
Participants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period
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Structured nutrition education
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum iron levels
時間枠：Baseline and week 16
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Serum iron concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
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Baseline and week 16
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Serum zinc levels
時間枠：Baseline and week 16
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Serum zinc concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
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Baseline and week 16
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Serum selenium levels
時間枠：Baseline and week 16
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Serum selenium concentration (µg/L) measured in HIV-seropositive adults as indicator of micronutrient status.
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Baseline and week 16
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Body mass Index (kg/m2)
時間枠：Baseline and week 16
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Calculated using measured weight (kg) and height (m) to determine nutritional status of participants
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Baseline and week 16
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Meal Frequency
時間枠：Baseline and week 16
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Number of meals consumed per day among HIV-positive adults, used to assess dietary intake pattern
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Baseline and week 16
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Dietary Diversity
時間枠：Baseline and Week 16
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Variety of foods groups consumed by HIV-positive adults, assessed using dietary diversity score based on 10 food group classification
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Baseline and Week 16
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Food Quantity Intake
時間枠：Baseline and week 16
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Quantity of food consumed by HIV-positive adults, assessed in (grams) consumed per day to evaluate dietary intake levels.
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Baseline and week 16
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Vegetable Preparation Methods
時間枠：Baseline and week 16
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Methods used in vegetable preparation among HIV-positive adults, including steaming, boiling and draining water, boiling and not draining water.
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Baseline and week 16
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Cassava root -simsim seed granules consumption
時間枠：Baseline and week 16
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Daily consumption of cassava root-simsim seed food-based product among HIV-positive adults as part of the dietary intervention.
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Baseline and week 16
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Florence F Habwe, PhD、Maseno University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年4月11日
一次修了 (実際)
2024年11月29日
研究の完了 (実際)
2024年12月6日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年5月27日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月2日
QC基準を満たした最後の更新が送信されました
2026年5月27日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MSU/DRPI/MUSERC/01295/23
- 1R01MH107330 (米国 NIH グラント/契約)
- NACOSTI/P/24/32560 (その他の識別子：National Commission for Science, Technology & Innovation)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Individual participant data collected that support the results reported in this article will be shared
IPD 共有時間枠
Immediately following publication, and upon completion of PhD course
IPD 共有アクセス基準
Anyone who wishes to access the data for research purposes.
IPD will be accessed at the Maseno University Institutional Repository in form of text, tables, figures, appendices
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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