- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Kisumu, 케냐, 40105
- Chulaimbo County Hospital
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Kisumu, 케냐, 40105
- Nyahera Sub County Hospital
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
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활성 비교기: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum iron levels
기간: Baseline and week 16
|
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
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Meal Frequency
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline and week 16
|
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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공동 작업자 및 조사자
수사관
- 수석 연구원: Florence F Habwe, PhD, Maseno University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MSU/DRPI/MUSERC/01295/23
- 1R01MH107330 (미국 NIH 보조금/계약)
- NACOSTI/P/24/32560 (기타 식별자: National Commission for Science, Technology & Innovation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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