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RecruitingNCT07836322Updated Nov 3, 2026

SHIFT-TB: Nutrition Intervention and Evaluation

An interventional study of Community-Based Nutrition Intervention in Underweight and Overweight and Obesity, sponsored by National University of Singapore. Recruiting at 1 site in Cambodia. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by National University of Singapore · Not applicable, Interventional, and Other

Updated Nov 3, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Underweight
  • Overweight and Obesity
03

In context

Thinness

66 studies on the registry are indexed under Thinness; 11 are open to participants now.

This study's planned enrollment of 700 is above the median of 287 across 43 interventional studies indexed under Thinness.

Browse Thinness studies →

Lead sponsor

National University of Singapore is the lead sponsor of 212 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 27, 2026. See what changed

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 20 years or older
  • Underweight ( \<18.5 kg/m²) or overweight/obese (BMI ≥25 kg/m²)
  • Residing in a selected study village
  • Able and willing to provide written

Exclusion criteria

Exclusion Criteria:

  • Unable to provide
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
700 participants (estimated)

Study arms

  • Experimental
    Community-Based Nutrition Intervention

    Behavioral: Community-Based Nutrition Intervention

  • No intervention
    Control

Interventions

  • BehavioralCommunity-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.

06

What researchers measure

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 7

Secondary 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 7

  2. Waist Circumference

    Waist circumference measured in centimeters using standardized anthropometric procedures.

    Time frame: Month 3 and Month 7

  3. 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 7

  4. 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 7

  5. 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.

    Time frame: Month 3 and Month 7

07

Study locations

1 of 1 sites recruiting
  • Khmer Hiv/Aids Ngo Alliance
    Phnom Penh, Phnom Penh, Cambodia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — There is currently no plan to share de-identified individual participant data with researchers outside the study team.

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 3, 2026
Sites
Khmer Hiv/Aids Ngo Alliance is now Recruiting
Nov 3, 2026
Eligibility
1 exclusion criterion edited, 1 added
What changed in the criteria
Exclusion criteria
  • AddedCurrently pregnant or within six months postpartum
  • EditedMedicalHaving medical or cognitive condition that would prevent participation in the intervention or completion of study assessments, as determined by the study team
Oct 27, 2026
Show all 2 updates
  1. Nov 3, 2026
    Not yet recruiting→Recruiting
    Khmer Hiv/Aids Ngo Alliance is now Recruiting
    + 2 other changes: verification date and date precision
  2. Oct 27, 2026
    Eligibility 1 exclusion criterion edited, 1 added
    What changed in the criteria
    Exclusion criteria
    • AddedCurrently pregnant or within six months postpartum
    • EditedMedicalHaving medical or cognitive condition that would prevent participation in the intervention or completion of study assessments, as determined by the study team
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07836322
Collaborators
KHANA Center for Population Health Research
Responsible party
Siyan Yi (Associate Professor, National University of Singapore) — Principal investigator
First posted
Sep 23, 2026
Start date
Oct 28, 2026
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Siyan Yi, PhD
Contact
siyan@nus.edu.sg
+65 8753 3823

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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