SHIFT-TB: Nutrition Intervention and Evaluation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational University of Singapore
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable to provide informed consent
Planning to move out of the study area during the intervention period
Medical or cognitive condition that would prevent participation in the intervention or completion of study assessments, as determined by the study team
Trial design
Design model
Parallel
Treatments tested in this trial
Community-Based Nutrition Intervention
BehavioralThe 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.
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Community-Based Nutrition InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Minimum dietary diversity
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.
Time frame
Month 3 and Month 7Secondary outcomes
1
Body Mass Index (BMI)
BMI calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame
Month 3 and Month 72
Waist Circumference
Waist circumference measured in centimeters using standardized anthropometric procedures.
Time frame
Month 3 and Month 73
Nutrition Knowledge Score
Nutrition knowledge will be assessed using the study questionnaire. Total scores range from 0 to 10, with higher scores indicating greater nutrition knowledge.
Time frame
Month 3 and Month 74
Health-Related Quality of Life: EQ-5D-5L Utility Index
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.
Time frame
Month 3 and Month 7Sponsors and contacts
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National University of Singapore
Lead sponsor
KHANA Center for Population Health Research
Collaborator
Source ClinicalTrials.gov
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