StuntingNCT04579328
Impact of Life-size Growth Charts on Understanding of Stunting
A study testing Exposure to Growth Mats in people with Stunting, run by Tufts University at 1 site in United States.
Trial summary
Randomized control trial testing whether exposure to a wall hanging (growth mat) enabling parents to physically compare their children's height against the World Health Organization (WHO) standards for height-for-age in combination with normal messaging on stunting increases parents' understanding and retention of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stunting
- What is being tested?
- Exposure to Growth Mats
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,019 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- membership and regular participation in the selected neighbor groups
Who cannot join
- extended absence from the village during the intervention period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Budikadidi: Making Stunting Visible Trial
Randomized control trial testing whether exposure to a wall hanging (growth mat) enabling parents to physically compare their children's height against the World Health Organization (WHO) standards for height-for-age in combination with normal messaging on stunting increases parents' understanding and retention of those messages. Both intervention and control groups will receive messages about stunting over a 3-month period, but the intervention group will also be exposed to the growth mats during the 3-month intervention period. Parents in both groups will be tested post intervention on the messages about stunting and scores will be compared.
Read the detailed description
This study is embedded within a development program implemented by a consortium led by Catholic Relief Services. The program aims to improve child nutrition, in part, through behavior change messaging. Parents have difficulty understanding that stunting is a problem because the high prevalence (57%) means the entire population curve has shifted to the left - a stunted child appears normal when compared to others in the community.
Through previous work, we have designed a wall-hanging like a life-size, color coded growth chart. Using 2 stage sampling, with parents clustered in neighbor groups, neighbor groups have been randomly assigned to intervention or control. Both groups will receive standard lessons on stunting while only the intervention group will have the growth mats incorporated into the lessons. After 3 months of exposure to the lessons, parents will be tested on their understanding of the key lesson points. Scores between groups will be tested for statistical differences. Qualitative focus groups throughout the intervention period will collect information on perception of the message delivery and the utility of the growth mats.
- Conditions
- Stunting
- Being tested
- Exposure to Growth Mats
- Keywords
- stunting, height-for-age, behavior change, malnutrition
- Medical subject headings
- Growth Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to Growth MatsBehavioural
see arm/group descriptions for description of intervention
| Study group | Role | What they receive |
|---|---|---|
| Lessons with Growth Mats | Experimental | Participants, clustered by neighbor groups, will be given lessons on stunting. During the lessons the trainers will use the growth mats to demonstrate their points. In these villages, village-wide events will expose the full community to the messages in combination to the mats. Receives: Behavioral: Exposure to Growth Mats |
| Lessons without Mats | No intervention | Participants, clustered by neighbor groups, will be given lessons on stunting without the aid of the growth mats. In these villages, village-wide events will expose the full community to the messages without the aid of the mats. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of key messages on stunting
there are multiple key points in the lessons on stunting accompanying the mats. Interviews will test the level of understanding for each key message, combining them into a composite score. Both individual and composite scores will be compared.
Measured: after 3 months of exposure to the lessons
Secondary outcomes (1)
Willingness to change behavior
Interviews will measure self-reported willingness to practice the recommended behaviors to reduce stunting
Measured: after 3 months of exposure to the lessons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2020
- Primary completion10 Mar 2021
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StuntingStudies 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
- Model description
- Participants are assigned to intervention and control groups. At the end of a 3-month intervention, differences in comprehension of messages on stunting will be measured. Additionally, focus groups in the general community will collect information on perceptions of the messages and growth mats.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic Relief Services, United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Merry Fitzpatrick, Tufts University
- Investigators
- Merry Fitzpatrick, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579328
- Sponsor's protocol ID
- STUDY00000386
- Status last verified
- May 2021
- First submitted
- 1 Oct 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw, non-identifiable results from the questions related to understanding of stunting will be available in .xlsx format from the PI.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Budikadidi: Making Stunting Visible Trial
- ClinicalTrials.gov ID
- NCT04579328
- Acronym / sponsor ID
- STUDY00000386
- Conditions
- Stunting
- Keywords
- stunting, height-for-age, behavior change, malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,019 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Catholic Relief Services, United States Agency for International Development (USAID)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 8 Oct 2020 (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.
Randomized control trial testing whether exposure to a wall hanging (growth mat) enabling parents to physically compare their children's height against the World Health Organization (WHO) standards for height-for-age in combination with normal messaging on stunting increases parents' understanding and retention of those messages. Both intervention and control groups will receive messages about stunting over a 3-month period, but the intervention group will also be exposed to the growth mats during the 3-month intervention period. Parents in both groups will be tested post intervention on the messages about stunting and scores will be compared.
Detailed description
This study is embedded within a development program implemented by a consortium led by Catholic Relief Services. The program aims to improve child nutrition, in part, through behavior change messaging. Parents have difficulty understanding that stunting is a problem because the high prevalence (57%) means the entire population curve has shifted to the left - a stunted child appears normal when compared to others in the community.
Through previous work, we have designed a wall-hanging like a life-size, color coded growth chart. Using 2 stage sampling, with parents clustered in neighbor groups, neighbor groups have been randomly assigned to intervention or control. Both groups will receive standard lessons on stunting while only the intervention group will have the growth mats incorporated into the lessons. After 3 months of exposure to the lessons, parents will be tested on their understanding of the key lesson points. Scores between groups will be tested for statistical differences. Qualitative focus groups throughout the intervention period will collect information on perception of the message delivery and the utility of the growth mats.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to intervention and control groups. At the end of a 3-month intervention, differences in comprehension of messages on stunting will be measured. Additionally, focus groups in the general community will collect information on perceptions of the messages and growth mats.
| Arm | Type | Receives |
|---|---|---|
| Lessons with Growth Mats | Experimental | Behavioral: Exposure to Growth MatsParticipants, clustered by neighbor groups, will be given lessons on stunting. During the lessons the trainers will use the growth mats to demonstrate their points. In these villages, village-wide events will expose the full community to the messages in combination to the mats. |
| Lessons without Mats | No intervention | –Participants, clustered by neighbor groups, will be given lessons on stunting without the aid of the growth mats. In these villages, village-wide events will expose the full community to the messages without the aid of the mats. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- membership and regular participation in the selected neighbor groups
Key exclusion criteria (1 listed)
- extended absence from the village during the intervention period
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 |
|---|---|---|
| Exposure to Growth Matssee arm/group descriptions for description of intervention | Behavioural | Lessons with Growth Mats |
Primary outcome
Understanding of key messages on stunting
Time frame: after 3 months of exposure to the lessons
there are multiple key points in the lessons on stunting accompanying the mats. Interviews will test the level of understanding for each key message, combining them into a composite score. Both individual and composite scores will be compared.
1 secondary outcome
Willingness to change behavior
Time frame: after 3 months of exposure to the lessons
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: Yes. Raw, non-identifiable results from the questions related to understanding of stunting will be available in .xlsx format from the PI.
Related trials for Stunting
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Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
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RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
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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. This study is not recruiting at the moment.
Merry Fitzpatrick, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to Growth Mats in people with Stunting, run by Tufts University at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 May 2021. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding of key messages on stunting (time frame: after 3 months of exposure to the lessons). 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 6 May 2021.