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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Siyan Yi, PhD
- Telefoonnummer: +65 8753 3823
- E-mail: siyan@nus.edu.sg
Studie Locaties
-
-
Phnom Penh
-
Phnom Penh, Phnom Penh, Cambodja
- Werving
- Khmer Hiv/Aids Ngo Alliance
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Controle
|
|
|
Experimenteel: Community-Based Nutrition Intervention
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Minimum dietary diversity
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body Mass Index (BMI)
Tijdsspanne: 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
Tijdsspanne: Month 3 and Month 7
|
Waist circumference measured in centimeters using standardized anthropometric procedures. |
Month 3 and Month 7
|
|
Nutrition Knowledge Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NUS-IRB-2025-810
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
There is currently no plan to share de-identified individual participant data with researchers outside the study team.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .