SHIFT-TB: Nutrition Intervention and Evaluation
Community-Based Nutrition Intervention for Adults With Malnutrition in Cambodia: A Hybrid Type 1 Effectiveness-Implementation Cluster Randomized Trial
The goal of this trial is to evaluate a community-based nutrition intervention for adults in Cambodia who are underweight or overweight/obese. This study will examine the effects of the nutrition intervention on participants' dietary diversity and will also assess how acceptable and feasible the intervention is to deliver in the community settings.
Health centers were randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a six-month, community-based nutrition intervention delivered by the Village Health Support Groups, while participants in the control group will not receive it.
Researchers will compare the two groups to determine the effect of the intervention on dietary diversity. Participants will complete study assessments at the beginning of the study, at 3 months, and at 7 months.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This Hybrid-Type 1 effectiveness-implementation cluster randomized trial will be conducted in two provinces in Cambodia. Health centers will serve as units of randomization and will be allocated to either the intervention or control arm.
The primary aim of the study is to evaluate the effectiveness of a community-based nutrition intervention in improving dietary diversity among adults with underweight or overweight/obesity. Concurrently, the study also aims to examine the implementation evaluation of acceptability, adoption, appropriateness, feasibility, fidelity, and implementation cost of the intervention
The intervention will be delivered primarily by Village Health Support Groups with support and supervision from the health center staff. The implementation evaluation will use quantitative and qualitative methods to understand how the intervention is delivered and experienced and to identify factors that may influence its future implementation.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Siyan Yi, PhD
- Número de teléfono: +65 8753 3823
- Correo electrónico: siyan@nus.edu.sg
Ubicaciones de estudio
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Phnom Penh
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Phnom Penh, Phnom Penh, Camboya
- Reclutamiento
- Khmer Hiv/Aids Ngo Alliance
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 20 years or older
- Underweight (BMI <18.5 kg/m²) or overweight/obese (BMI ≥25 kg/m²)
- Residing in a selected study village
- Able and willing to provide written informed consent
Exclusion Criteria:
- Unable to provide informed consent
- Currently pregnant or within six months postpartum
- Planning to move out of the study area during the intervention period
- Having medical or cognitive condition that would prevent participation in the intervention or completion of study assessments, as determined by the study team
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
|
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Experimental: Community-Based Nutrition Intervention
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The nutrition intervention will be delivered over six months and will comprise four core components: (1) capacity building and ongoing support for VHSGs and health center staff; (2) nutrition education and behavior-change support; (3) continued reinforcement and follow-up; and (4) ongoing monitoring, referral, and linkage to care. Health center staff will receive a half-day of training delivered by operational district officers. Subsequently, health center staff will train the VHSGs. Following this capacity-building training, community-based delivery will proceed through three phases: initial group sessions at M0 and M1, active reinforcement from M2 to M4, and maintenance from M5 to M6. Core intervention components and content will be standardized across intervention sites. Group nutrition education sessions are delivered to enrolled participants and, where applicable, to household food decision-makers. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Minimum dietary diversity
Periodo de tiempo: Month 3 and Month 7
|
Minimum dietary diversity will be assessed using the Diet Quality Questionnaire (DQQ). Participants will be classified as meeting or not meeting minimum dietary diversity based on consumption of at least 5 of 10 defined food groups during the previous day or night. |
Month 3 and Month 7
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body Mass Index (BMI)
Periodo de tiempo: Month 3 and Month 7
|
BMI calculated as weight in kilograms divided by height in meters squared (kg/m²). |
Month 3 and Month 7
|
|
Waist Circumference
Periodo de tiempo: Month 3 and Month 7
|
Waist circumference measured in centimeters using standardized anthropometric procedures. |
Month 3 and Month 7
|
|
Nutrition Knowledge Score
Periodo de tiempo: Month 3 and Month 7
|
Nutrition knowledge will be assessed using the study questionnaire. Total scores range from 0 to 10, with higher scores indicating greater nutrition knowledge. |
Month 3 and Month 7
|
|
Health-Related Quality of Life: EQ-5D-5L Utility Index
Periodo de tiempo: Month 3 and Month 7
|
Responses to the EQ-5D-5L will be converted to utility index values using the Vietnamese EQ-5D-5L value set. Possible values range from -0.5115 to 1, with higher values indicating better health-related quality of life. |
Month 3 and Month 7
|
|
Self-Rated Health: EQ Visual Analogue Scale
Periodo de tiempo: Month 3 and Month 7
|
Self-rated health measured using the EuroQol visual analogue scale (EQ-VAS). Scores range from 0 (worst health imaginable) to 100 (best health imaginable); higher scores indicate better self-rated health. |
Month 3 and Month 7
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NUS-IRB-2025-810
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
There is currently no plan to share de-identified individual participant data with researchers outside the study team.
Información sobre medicamentos y dispositivos, documentos del estudio
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