MalnutritionNCT03516396
Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
A study testing Training Plus, Training Only and No Inputs then Community development and training in people with Malnutrition, run by Tufts University.
Trial summary
Heifer Project International is a globally active NGO with more than 400 projects in over 30 countries. The organization uses the introduction of livestock and related training in the development of social capital as tools for poverty alleviation, citizen empowerment, and community development. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Training Plus, Training Only and No Inputs then Community development and training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2013to 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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child in household in designated study area of Nepal, age 1 month to 12 years
- family agrees to enrollment
Who cannot join
- parent refuse to enroll child
About this study
Heifer Project International is a globally active NGO with more than 400 projects in over 30 countries. The organization uses the introduction of livestock and related training in the development of social capital as tools for poverty alleviation, citizen empowerment, and community development. In a pilot project conducted in 2009-2012, these activities were found to promote some improvement in child health and nutritional status. However, robust enhancement of these important indicators was not observed. Heifer now intends to investigate the efficacy of a nutrition and child health education program in amplifying these effects.
Read the detailed description
Child health and survival remain significant challenges in Nepal. Nepal is ranks 63rd highest in the world for "under 5 mortality" rate, with 54/1000 children dying before their 5th birthdays and 46/1000 infants dying before their first birthdays. Annually, more than 47,000 children die before reaching age 5 years. At these mortality levels, one in every 22 Nepalese children dies before reaching age 1, and one in every 19 does not survive to his or her fifth birthday. Nutritional status of children is extremely poor, with ~29% of children underweight and 41% stunted (respectively, weight and height <-2 SD from median) (UNICEF, 2011) (Ministry of Health and Population et al., 2012).
Heifer Project International is a globally active NGO with more than 400 projects in over 30 countries. The organization uses the introduction of livestock and related training in the development of social capital as tools for poverty alleviation, citizen empowerment, and community development. Heifer International recognizes the links between poverty, child malnutrition, and disease. However, improving economic indicators is not always sufficient to improve child outcomes. Thus, the organization now wishes to conduct a systematic assessment to evaluate the effects of introducing a child health and nutrition component into their work, and to clarify the links (if any) between social capital training and child growth and health. In doing so, Heifer International expects to develop a model which could be adapted for use in other regions of the world. The interaction of Heifer community development activities, specific child and family characteristics, and child health and nutritional status will also be explored.
- Conditions
- Malnutrition
- Being tested
- Training Plus, Training Only, No Inputs then Community development and training
- Keywords
- Nepal, child growth, nutrition education, community development
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training PlusBehavioural
Training plus enhanced community development activities
Training OnlyBehavioural
Training Only (livestock management and child nutrition) for 24 months then add community development inputs
No Inputs then Community development and trainingBehavioural
No inputs for 24 months then add community development and training
| Study group | Role | What they receive |
|---|---|---|
| Training Plus | Experimental | Intervention: Community Development
Training plus enhanced community development activities Receives: Behavioral: Training Plus |
| Control | Active comparator | No inputs Receives: Behavioral: No Inputs then Community development and training |
| Training Only | Experimental | Intervention: Training
Training Only (livestock management and child nutrition) Receives: Behavioral: Training Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in prevalence of child wasting
measurement of child's weight in kg and height in cm. These measurements will be converted respectively to weight z scores, height z scores and then weight-for-height z scores using World Health Organization standards. The proportion of wasted children (z score <-2) will be determined.
Measured: baseline, and then at each study visit (every 6 months over 36 months)
Secondary outcomes (3)
child health
Mothers will report the frequency that their child experienced respiratory infection, diarrhea, and/or fever within the 2 weeks prior to the study visit. The presence or absence of each of these symptoms will be scored as either "0" or "1", respectively. These totals will be summed to provide a "health score".
Measured: at each study visit (every 6 months over 36 months)
household socioeconomic (SES) status
Household possessions will be enumerated (e.g., the presence or absence of such items as refrigerator, telephone, car, computer, radio, television). Using principal components analysis, a household SES score will be calculated.
Measured: at each study visit (every 6 months over 36 months)
child developmental status
Developmental status of children 66 months of age will be ascertained using the Ages and Stages Questionnaire (for ages 24-66 months). This test combines observation and parent report.
Measured: at one study visit each year, starting 12 months after randomization, then annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Jul 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Sequential
- Model description
- Randomized cluster design of households in rural Nepal. Groups will be randomized to receive either: (a) Training Only (livestock management and child nutrition), (b) Training plus enhanced community development activities, or (c) no inputs (Control). After 24 months, groups A and C will receive community development inputs
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Heifer Project International
- Responsible party
- Principal investigator, Laurie Miller, MD, Tufts University
- Investigators
- Laurie C Miller, MD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516396
- Sponsor's protocol ID
- AID-OAA-L-1-00006
- Status last verified
- Jul 2020
- First submitted
- 9 Apr 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miller LC, Neupane S, Joshi N, Lohani M, Rogers BL, Neupane S, Ghosh S, Webb P. Multisectoral community development in Nepal has greater effects on child growth and diet than nutrition education alone. Public Health Nutr. 2020 Jan;23(1):146-161. doi: 10.1017/S136898001900260X. Epub 2019 Sep 23.
PubMed 31544735
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
- ClinicalTrials.gov ID
- NCT03516396
- Acronym / sponsor ID
- AID-OAA-L-1-00006
- Conditions
- Malnutrition
- Keywords
- Nepal, child growth, nutrition education, community development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Heifer Project International
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 May 2018 (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.
Heifer Project International is a globally active NGO with more than 400 projects in over 30 countries. The organization uses the introduction of livestock and related training in the development of social capital as tools for poverty alleviation, citizen empowerment, and community development. In a pilot project conducted in 2009-2012, these activities were found to promote some improvement in child health and nutritional status. However, robust enhancement of these important indicators was not observed. Heifer now intends to investigate the efficacy of a nutrition and child health education program in amplifying these effects.
Detailed description
Child health and survival remain significant challenges in Nepal. Nepal is ranks 63rd highest in the world for "under 5 mortality" rate, with 54/1000 children dying before their 5th birthdays and 46/1000 infants dying before their first birthdays. Annually, more than 47,000 children die before reaching age 5 years. At these mortality levels, one in every 22 Nepalese children dies before reaching age 1, and one in every 19 does not survive to his or her fifth birthday. Nutritional status of children is extremely poor, with ~29% of children underweight and 41% stunted (respectively, weight and height <-2 SD from median) (UNICEF, 2011) (Ministry of Health and Population et al., 2012).
Heifer Project International is a globally active NGO with more than 400 projects in over 30 countries. The organization uses the introduction of livestock and related training in the development of social capital as tools for poverty alleviation, citizen empowerment, and community development. Heifer International recognizes the links between poverty, child malnutrition, and disease. However, improving economic indicators is not always sufficient to improve child outcomes. Thus, the organization now wishes to conduct a systematic assessment to evaluate the effects of introducing a child health and nutrition component into their work, and to clarify the links (if any) between social capital training and child growth and health. In doing so, Heifer International expects to develop a model which could be adapted for use in other regions of the world. The interaction of Heifer community development activities, specific child and family characteristics, and child health and nutritional status will also be explored.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized cluster design of households in rural Nepal. Groups will be randomized to receive either: (a) Training Only (livestock management and child nutrition), (b) Training plus enhanced community development activities, or (c) no inputs (Control). After 24 months, groups A and C will receive community development inputs
| Arm | Type | Receives |
|---|---|---|
| Training Plus | Experimental | Behavioral: Training PlusIntervention: Community Development Training plus enhanced community development activities |
| Control | Active comparator | Behavioral: No Inputs then Community development and trainingNo inputs |
| Training Only | Experimental | Behavioral: Training OnlyIntervention: Training Training Only (livestock management and child nutrition) |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child in household in designated study area of Nepal, age 1 month to 12 years
- family agrees to enrollment
Key exclusion criteria (1 listed)
- parent refuse to enroll child
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 |
|---|---|---|
| Training PlusTraining plus enhanced community development activities | Behavioural | Training Plus |
| Training OnlyTraining Only (livestock management and child nutrition) for 24 months then add community development inputs | Behavioural | Training Only |
| No Inputs then Community development and trainingNo inputs for 24 months then add community development and training | Behavioural | Control |
Primary outcome
Change from baseline in prevalence of child wasting
Time frame: baseline, and then at each study visit (every 6 months over 36 months)
measurement of child's weight in kg and height in cm. These measurements will be converted respectively to weight z scores, height z scores and then weight-for-height z scores using World Health Organization standards. The proportion of wasted children (z score <-2) will be determined.
3 secondary outcomes
child health
Time frame: at each study visit (every 6 months over 36 months)
household socioeconomic (SES) status
Time frame: at each study visit (every 6 months over 36 months)
child developmental status
Time frame: at one study visit each year, starting 12 months after randomization, then annually
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Derived from this study: PubMed 31544735Miller LC, Neupane S, Joshi N, Lohani M, Rogers BL, Neupane S, Ghosh S, Webb P. Multisectoral community development in Nepal has greater effects on child growth and diet than nutrition education alone. Public Health Nutr. 2020 Jan;23(1):146-161. doi: 10.1017/S136898001900260X. Epub 2019 Sep 23.
- Individual participant dataSharing planned: Undecided
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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.
Laurie C Miller, MD principal investigator
Tufts University
Questions about this trial
What is this clinical trial studying?
A study testing Training Plus, Training Only and No Inputs then Community development and training in people with Malnutrition, run by Tufts University.
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 2 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: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in prevalence of child wasting (time frame: baseline, and then at each study visit (every 6 months over 36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516396, which also lists 1 linked publication.
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 15 Jul 2020.