UndernutritionNCT04640389
Rural-urban Disparities in the Nutritional Status of Younger Adolescents in Tanzania.
An observational study of Undernutrition and Stunting, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
Africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. These challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Undernutrition, Stunting, Adolescent Development
- How many people
- 1,125 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2020
- Phase
- Observational
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This cross-sectional study merged and analyzed two independent samples of adolescents living in Tanzania. One study was conducted in Tanzania by Cordeiro et al. (2012) and the other was conducted in an urban setting by Carlson, Brennan, and Earls (2012); both conducted in 2004. The Kilosa/rural dataset was derived from a two-stage sampling plan for selection of villages and adolescents. The Moshi/urban dataset was derived from a two-stage sampling plan for a cluster randomized control trial (CRCT). From a total combined sample of 1476 adolescents aged 10-19 years across both datasets, 1237 met the age criterion for younger adolescents (10-14 years). The analytical sample for this study was 1125.
Who may be able to join
- Adolescents between 10 and 14 years of age
Who cannot join
- Adolescents living away from the districts and not physically present at the time of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Amherst
Amherst, Massachusetts, 01003-9282
About this study
Africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. These challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. This cross-sectional study examined disparities in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among 1125 adolescents in Tanzania. Rural-urban disparities in nutritional status were significant and gendered. Findings confirm place of residence as a key determinant of BAZ, HAZ, and stunting among adolescents in Tanzania. Targeted gender-sensitive interventions among adolescents, particularly in rural areas, are needed to limit growth faltering and improve health outcomes.
Read the detailed description
Africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. These challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. This cross-sectional study examined disparities in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among 1125 adolescents in Tanzania. Pearson's chi-square tested associations between rural/urban residence and undernutrition (BAZ <-2SD), stunting (HAZ <-2SD), anthropometric, socioeconomic, and health indicators. Multivariate linear regression identified predictors of BAZ and HAZ.
Funding: UNICEF/ Tanzania; United States National Institute of Mental Health (R01 MH66801).
- Conditions
- Undernutrition, Stunting, Adolescent Development
- Being tested
- Cross-sectional study/no intervention
- Medical subject headings
- Malnutrition, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional study/no interventionOther
Cross-sectional study/no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Urban | Urban adolescents living in Moshi District, Tanzania, who are between 10-14 years of age. Receives: Other: Cross-sectional study/no intervention | |
| Rural | Rural adolescents living in Kilosa District, Tanzania, who are between 10-14 years of age. Receives: Other: Cross-sectional study/no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index for age and gender z-scores
Weight (Kg)/Height (M) squared compared to the WHO growth reference standard
Measured: Two measures collected consequentially during a 30 minute time frame on the date of survey administration.
Height for age and gender z-scores
Height in meters for age and gender compared to the WHO growth reference standard
Measured: Two measures collected consequentially during a 30 minute time frame on the date of survey administration.
Undernutrition
Body Mass Index for age and gender z-scores < -2SD of the WHO growth reference standard
Measured: Height and weight measures collected twice consequentially during a 30 minute time frame on the date of survey administration.
Stunting
Height (M) for age and gender z-scores < -2SD of the WHO growth reference
Measured: Two measures of height in meters collected consequentially during a 30 minute time frame on the date of survey administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study startNov 2013
- Primary completionSep 2018
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, Harvard University, Tufts University
- Responsible party
- Principal investigator, Lorraine Cordeiro, University of Massachusetts, Amherst
- Investigators
- Lorraine Cordeiro, Ph.D., Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640389
- Sponsor's protocol ID
- 15-008
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cordeiro LS, Wilde PE, Semu H, Levinson FJ. Household food security is inversely associated with undernutrition among adolescents from Kilosa, Tanzania. J Nutr. 2012 Sep;142(9):1741-7. doi: 10.3945/jn.111.155994. Epub 2012 Jul 18.
PubMed 22810984Carlson M, Brennan RT, Earls F. Enhancing adolescent self-efficacy and collective efficacy through public engagement around HIV/AIDS competence: a multilevel, cluster randomized-controlled trial. Soc Sci Med. 2012 Sep;75(6):1078-87. doi: 10.1016/j.socscimed.2012.04.035. Epub 2012 May 24.
PubMed 22703885
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural-urban Disparities in the Nutritional Status of Younger Adolescents in Tanzania.
- ClinicalTrials.gov ID
- NCT04640389
- Acronym / sponsor ID
- 15-008
- Conditions
- Undernutrition, Stunting, Adolescent Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,125 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- UNICEF, Harvard University, Tufts University
- Study start
- Nov 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 23 Nov 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.
Africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. These challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. This cross-sectional study examined disparities in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among 1125 adolescents in Tanzania. Rural-urban disparities in nutritional status were significant and gendered. Findings confirm place of residence as a key determinant of BAZ, HAZ, and stunting among adolescents in Tanzania. Targeted gender-sensitive interventions among adolescents, particularly in rural areas, are needed to limit growth faltering and improve health outcomes.
Detailed description
Africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. These challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. This cross-sectional study examined disparities in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among 1125 adolescents in Tanzania. Pearson's chi-square tested associations between rural/urban residence and undernutrition (BAZ <-2SD), stunting (HAZ <-2SD), anthropometric, socioeconomic, and health indicators. Multivariate linear regression identified predictors of BAZ and HAZ.
Funding: UNICEF/ Tanzania; United States National Institute of Mental Health (R01 MH66801).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urban | – | Other: Cross-sectional study/no interventionUrban adolescents living in Moshi District, Tanzania, who are between 10-14 years of age. |
| Rural | – | Other: Cross-sectional study/no interventionRural adolescents living in Kilosa District, Tanzania, who are between 10-14 years of age. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This cross-sectional study merged and analyzed two independent samples of adolescents living in Tanzania. One study was conducted in Tanzania by Cordeiro et al. (2012) and the other was conducted in an urban setting by Carlson, Brennan, and Earls (2012); both conducted in 2004. The Kilosa/rural dataset was derived from a two-stage sampling plan for selection of villages and adolescents. The Moshi/urban dataset was derived from a two-stage sampling plan for a cluster randomized control trial (CRCT). From a total combined sample of 1476 adolescents aged 10-19 years across both datasets, 1237 met the age criterion for younger adolescents (10-14 years). The analytical sample for this study was 1125.
Key inclusion criteria (1 listed)
- Adolescents between 10 and 14 years of age
Key exclusion criteria (1 listed)
- Adolescents living away from the districts and not physically present at the time of the study
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 |
|---|---|---|
| Cross-sectional study/no interventionCross-sectional study/no intervention. | Other | Rural, Urban |
Primary outcome
Body Mass Index for age and gender z-scores
Time frame: Two measures collected consequentially during a 30 minute time frame on the date of survey administration.
Weight (Kg)/Height (M) squared compared to the WHO growth reference standard
Height for age and gender z-scores
Time frame: Two measures collected consequentially during a 30 minute time frame on the date of survey administration.
Height in meters for age and gender compared to the WHO growth reference standard
Undernutrition
Time frame: Height and weight measures collected twice consequentially during a 30 minute time frame on the date of survey administration.
Body Mass Index for age and gender z-scores < -2SD of the WHO growth reference standard
Stunting
Time frame: Two measures of height in meters collected consequentially during a 30 minute time frame on the date of survey administration.
Height (M) for age and gender z-scores < -2SD of the WHO growth reference
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 23 Nov 2020.
- Background: PubMed 22810984Cordeiro LS, Wilde PE, Semu H, Levinson FJ. Household food security is inversely associated with undernutrition among adolescents from Kilosa, Tanzania. J Nutr. 2012 Sep;142(9):1741-7. doi: 10.3945/jn.111.155994. Epub 2012 Jul 18.
- Background: PubMed 22703885Carlson M, Brennan RT, Earls F. Enhancing adolescent self-efficacy and collective efficacy through public engagement around HIV/AIDS competence: a multilevel, cluster randomized-controlled trial. Soc Sci Med. 2012 Sep;75(6):1078-87. doi: 10.1016/j.socscimed.2012.04.035. Epub 2012 May 24.
- Individual participant dataSharing planned: No
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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.
Lorraine Cordeiro, Ph.D. principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undernutrition and Stunting, run by University of Massachusetts, Amherst 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: finished, as of the sponsor's last update on 23 Nov 2020. 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?
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?
Body Mass Index for age and gender z-scores (time frame: Two measures collected consequentially during a 30 minute time frame on the date of survey administration.). 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?
On the ClinicalTrials.gov record for NCT04640389, which also lists 2 linked publications.
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 Nov 2020.