StuntingNCT03895164
Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation
A study testing Enhanced NE and Standard NE in people with Stunting and Anemia, run by SEAMEO Regional Centre for Food and Nutrition at 2 sites in Indonesia.
Trial summary
Stunting and anemia amongst under-two children are attributable to poor nutrient intakes. The study evaluates the effectiveness of nutrition education on local specific food-based complementary feeding recommendation (CFR) to improve dietary patterns and nutritional intakes, as well as reduce stunting and anemia among… Read more about this study
- Who is it for?
- Ages 6 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting, Anemia, Complementary Feeding Recommendation
- What is being tested?
- Enhanced NE and Standard NE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 926 participants
- Where
- 2 sitesIndonesia
- Study dates
- 19 Dec 2018to 31 Dec 2019
- 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 6 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-11 months old at baseline
- living in selected area during the study
- apparently healthy
- willing to take part in the study and taken venous blood sample by getting signed consent from parents
Who cannot join
- the child does not present during venous blood sample collection
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Malang District Health Office
Malang, West Java, 65163
Sambas District Health Office
Sambas, West Borneo, 79462
About this study
Official title: Utilization of Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation for Stunting and Anemia Prevention Among Under-two Children
Stunting and anemia amongst under-two children are attributable to poor nutrient intakes. The study evaluates the effectiveness of nutrition education on local specific food-based complementary feeding recommendation (CFR) to improve dietary patterns and nutritional intakes, as well as reduce stunting and anemia among under-two children.
- Conditions
- Stunting, Anemia, Complementary Feeding Recommendation, Linear Programming, Indonesia, Infant and Young Children
- Being tested
- Enhanced NE, Standard NE
- Medical subject headings
- Growth Disorders, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced NEBehavioural
Standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation
Standard NEBehavioural
Standard nutrition education package from primary health care
| Study group | Role | What they receive |
|---|---|---|
| Standard NE | Placebo comparator | Control Group will receive standard nutrition education package from primary health care. Receives: Behavioral: Standard NE |
| Enhanced NE | Experimental | Intervention Group will receive standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation Receives: Behavioral: Enhanced NE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anthropometric measurements
to measure the change in length measured by using WHO growth standard length-for-Age (Z-Score) before and after intervention period.
Measured: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in hemoglobin status
to measure the change in hemoglobin (g/L) before and after intervention
Measured: At baseline before intervention (week 0), at endpoint after intervention (week 24)
Change in iron status
to measure the change in serum ferritin (microgram/L) before and after intervention
Measured: At baseline before intervention (week 0), at endpoint after intervention (week 24)
Change in zinc status
to measure the change in serum zinc (mg/L) before and after intervention
Measured: At baseline before intervention (week 0), at endpoint after intervention (week 24)
Secondary outcomes (4)
Change in dietary patterns
Dietary patterns will be measured by using Dietary Diversity Score
Measured: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in iron intake
iron intake (mg/day)
Measured: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in zinc intake
zinc intake (mg/day)
Measured: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in calcium intake
calcium intake (mg/day)
Measured: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start19 Dec 2018
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control Group will receive standard nutrition education package from primary health care. Intervention Group will receive standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 926 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEAMEO Regional Centre for Food and Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia-MoH, Health Polytechnic of Pontianak, Health Polytechnic of Malang, Sambas District Health Office, Malang District Health Office, Universitas Indonesia
- Responsible party
- Principal investigator, Dr.Umi Fahmida, SEAMEO Regional Centre for Food and Nutrition
- Investigators
- Umi Fahmida, Dr., Principal investigator, SEAMEO Regional Centre for Food and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895164
- Sponsor's protocol ID
- LPBadutaSM
- Status last verified
- Mar 2019
- First submitted
- 21 Jan 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation for Stunting and Anemia Prevention Among Under-two Children
- ClinicalTrials.gov ID
- NCT03895164
- Acronym / sponsor ID
- LPBadutaSM
- Conditions
- Stunting, Anemia, Complementary Feeding Recommendation, Linear Programming, Indonesia, Infant and Young Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 926 participants (actual)
- Lead sponsor
- SEAMEO Regional Centre for Food and NutritionUniversity, hospital or other
- Collaborators
- Indonesia-MoH, Health Polytechnic of Pontianak, Health Polytechnic of Malang, Sambas District Health Office, Malang District Health Office, Universitas Indonesia
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 29 Mar 2019 (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.
Stunting and anemia amongst under-two children are attributable to poor nutrient intakes. The study evaluates the effectiveness of nutrition education on local specific food-based complementary feeding recommendation (CFR) to improve dietary patterns and nutritional intakes, as well as reduce stunting and anemia among under-two children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Control Group will receive standard nutrition education package from primary health care. Intervention Group will receive standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation.
| Arm | Type | Receives |
|---|---|---|
| Standard NE | Placebo comparator | Behavioral: Standard NEControl Group will receive standard nutrition education package from primary health care. |
| Enhanced NE | Experimental | Behavioral: Enhanced NEIntervention Group will receive standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation |
Who may qualify
- Ages
- 6 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 6-11 months old at baseline
- living in selected area during the study
- apparently healthy
- willing to take part in the study and taken venous blood sample by getting signed consent from parents
Key exclusion criteria (1 listed)
- the child does not present during venous blood sample collection
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 |
|---|---|---|
| Enhanced NEStandard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation | Behavioural | Enhanced NE |
| Standard NEStandard nutrition education package from primary health care | Behavioural | Standard NE |
Primary outcome
Change in anthropometric measurements
Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
to measure the change in length measured by using WHO growth standard length-for-Age (Z-Score) before and after intervention period.
Change in hemoglobin status
Time frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)
to measure the change in hemoglobin (g/L) before and after intervention
Change in iron status
Time frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)
to measure the change in serum ferritin (microgram/L) before and after intervention
Change in zinc status
Time frame: At baseline before intervention (week 0), at endpoint after intervention (week 24)
to measure the change in serum zinc (mg/L) before and after intervention
4 secondary outcomes
Change in dietary patterns
Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in iron intake
Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in zinc intake
Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Change in calcium intake
Time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Related trials for Stunting
Not yet recruiting
Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala
Stunting of Growth, Chronic Malnutrition
RecruitingPhase 3
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
Neurodevelopment Outcome, Linear Growth
Recruiting
Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services
Stunting, Gender Equality
RecruitingObservational study
Impact of Diet and Nutrition on Growth and Development in Young Children
Nutrition, Growth
Active, not recruiting
Comprehensive Nutritional Support for Children in Zambia (ZamCNC) - A Pilot Investigation
Malnourished Children, Stunting of Growth
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.
Umi Fahmida, Dr. principal investigator
SEAMEO Regional Centre for Food and Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced NE and Standard NE in people with Stunting and Anemia, run by SEAMEO Regional Centre for Food and Nutrition at 2 sites in Indonesia.
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 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 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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. Some participants in this study may receive a placebo. 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?
Change in anthropometric measurements (time frame: At baseline before intervention (week 0), at midpoint of intervention (week 12), at endpoint after intervention (week 24)). The study lists 4 primary outcomes in all. 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 29 Mar 2019; AzTrials last refreshed its copy on 27 Oct 2026.