UnderweightNCT07836322
SHIFT-TB: Nutrition Intervention and Evaluation
A study testing Community-Based Nutrition Intervention in people with Underweight and Overweight and Obesity, run by National University of Singapore at 1 site in Cambodia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Underweight, Overweight and Obesity
- What is being tested?
- Community-Based Nutrition Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteCambodia
- Study dates
- Oct 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Underweight, Overweight and Obesity
- Being tested
- Community-Based Nutrition Intervention
- Medical subject headings
- Thinness, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Based Nutrition InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community-Based Nutrition Intervention | Experimental | Not described Receives: Behavioral: Community-Based Nutrition Intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 3 and Month 7
Secondary outcomes (5)
Body Mass Index (BMI)
BMI calculated as weight in kilograms divided by height in meters squared (kg/m²).
Measured: Month 3 and Month 7
Waist Circumference
Waist circumference measured in centimeters using standardized anthropometric procedures.
Measured: Month 3 and Month 7
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.
Measured: Month 3 and Month 7
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.
Measured: Month 3 and Month 7
Self-Rated Health: EQ Visual Analogue Scale
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.
Measured: Month 3 and Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UnderweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- KHANA Center for Population Health Research
- Responsible party
- Principal investigator, Siyan Yi, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836322
- Sponsor's protocol ID
- NUS-IRB-2025-810
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share de-identified individual participant data with researchers outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Nutrition Intervention for Adults With Malnutrition in Cambodia: A Hybrid Type 1 Effectiveness-Implementation Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT07836322
- Acronym / sponsor ID
- NUS-IRB-2025-810
- Conditions
- Underweight, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- KHANA Center for Population Health Research
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-Based Nutrition Intervention | Experimental | Behavioral: Community-Based Nutrition Intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-Based Nutrition InterventionThe 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. | Behavioural | Community-Based Nutrition Intervention |
Primary outcome
Minimum dietary diversity
Time frame: 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.
5 secondary outcomes
Body Mass Index (BMI)
Time frame: Month 3 and Month 7
Waist Circumference
Time frame: Month 3 and Month 7
Nutrition Knowledge Score
Time frame: Month 3 and Month 7
Health-Related Quality of Life: EQ-5D-5L Utility Index
Time frame: Month 3 and Month 7
Self-Rated Health: EQ Visual Analogue Scale
Time frame: Month 3 and Month 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share de-identified individual participant data with researchers outside the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-Based Nutrition Intervention in people with Underweight and Overweight and Obesity, run by National University of Singapore at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siyan Yi, PhD (+65 8753 3823, siyan@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum dietary diversity (time frame: Month 3 and Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.