An observational study in Malnutrition (Calorie), sponsored by Abbott Nutrition. Recruiting at 1 site in United States. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Abbott Nutrition (part of Abbott) · Observational
The objective of this prospective, real-world evidence/pragmatic study with a quality improvement program approach is to evaluate the feasibility and effectiveness of a community-engaged nutrition-focused program utilizing nutrition screening, education, supplementation and continuous follow up for children and their families.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 158 is below the median of 206 across 393 observational studies indexed under Malnutrition.
Browse Malnutrition studies →Abbott Nutrition is the lead sponsor of 156 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Via screening by existing community-based programming via Children International (NGO)
Household Component
Inclusion
Exclusion
Organization Component
Inclusion
Exclusion
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Includes eligible Children and their Caregivers
NGO Staff
Program Feasibility
Caregiver and NGO staff program experience assessed via survey via Net Promoter Score (NPS) scored from 0 to 10 where higher score is more favorable
Time frame: Baseline to 12 months
Growth Anthropometrics
Change in Height (cm), Head Circumference (cm), Weight (kg) and Mid-Upper Arm Circumference (MUAC) (mm) as compared to pediatric growth standards (i.e. percentiles and z-scores)
Time frame: Baseline to 3, 6, 9, and 12 months
Healthcare Resource Utilization
Caregiver completed open ended questions to obtain the frequency of healthcare resource utilization including illness frequency, severity and related missed school/work days, where more utilization means worse outcomes.
Time frame: Baseline, 6 and 12 months
Pediatric Quality of Life Inventory
A 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life
Time frame: Baseline, 6, and 12 months
World Health Organization Quality of Life Brief Version
A 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life
Time frame: Baseline, 6, and 12 months
Nutrient Intake
Caregiver completed 24-hour dietary recall
Time frame: Baseline, 3, 6, 9, and 12 months
Pediatric Nutrition Risk Status via Anthropometrics
Calculated from anthropometrics measurements as compared to established standards
Time frame: Baseline, 3, 6, 9, and 12 months
Nutrition Behavior
Parent completed 35-item questionnaire, where higher scores indicate higher levels for that specific eating behavior
Time frame: Baseline, 6, and 12 months
Staff Experience Survey
Assesses caregiver experience, satisfaction, and recommendations for improvement regarding the nutrition program using a combination of closed- and open-ended questions. Closed-ended questions will use Likert-scale responses ranging from strongly disagree to strongly agree.
Time frame: 12 Months
Nutrition Program Enrollment and Adherence
Enrollment and adherence to the nutrition program
Time frame: 12 Months
Caregiver Experience Survey
Assesses caregiver experience, satisfaction, and recommendations for improvement regarding the nutrition program using a combination of closed- and open-ended questions in addition to the Net Promoter Score (NPS). Closed-ended questions will use Likert-scale responses ranging from strongly disagree to strongly agree or very unsatisfied to very satisfied.
Time frame: 12 Months
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jan 2028, 20 months after the start.
Of 186 observational studies under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 20 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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