Malnutrition (Calorie)STRIKENCT07524907
Stunting and Targeting Reduction of Impaired Growth in Kids Effectively
An observational study of Malnutrition (Calorie), run by Abbott Nutrition at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Malnutrition (Calorie)
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Via screening by existing community-based programming via Children International (NGO)
Who may be able to join
- Children aged 1-5 years experiencing stunting or its risk (defined as HAZ ≤ -1 SD at baseline)
- Children's legal guardian agrees to participate in the study
- Full term pregnancy (defined as ≥ 37 weeks gestation and ≥ 2500g birth weight)
- Residence in study area attending Children International (NGO) centers
- NGO staff taking part in nutrition screenings
- Agrees to participate in survey
Who cannot join
- Children who have current medical conditions requiring hospitalization: gastrointestinal tract infections or inflammatory bowel disease; active tuberculosis; acute hepatitis B or C; human immunodeficiency virus OR malignancy; cystic fibrosis; immunodeficiency syndromes, congenital abnormalities of the respiratory tract, such as lung and respiratory cilia; an unsuspected foreign body in the respiratory tract; asthma; heart abnormalities; abdominal hernias; and known metabolic disorders, renal impairment, or rheumatic diseases and diabetes
- Congenital condition
- Children with disabilities such as cerebral palsy, autism spectrum disorder, neurodegenerative disorders
- Children with chronic or acute infections e.g. HIV, malaria
- Children who are taking medications or other agents that could potentially affect body weight, including diuretics, appetite stimulants, steroids, and growth hormones
- Children who have genetic conditions impacting weight status such as but not limited to: Bardet-Biedl Syndrome, Prader-Willi Syndrome
Show all 14Show fewer
- Children already enrolled in a nutrition program that includes a supplement
- Participant has an allergy or intolerance to any ingredient in the study supplement, as reported by the parent.
- Children with sleep disorders such as but not limited to: obstructive sleep apnea, insomnia, parasomnias (sleepwalking, night terrors, bedwetting), delayed sleep phase syndrome, behavioral sleep disorders, circadian rhythm disorders
- Mental health disorders such as but not limited to: anxiety, depression
- Organization Component
- Not involved in the implementation of the study
- Not involved in working with pediatric stunting or its risk
- Declines participation in survey
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children International
Kansas City, Missouri, 64121
About this study
Official title: STRIKE: Stunting and Targeting Reduction of Impaired Growth in Kids Effectively: A Community Engaged Comprehensive, Multi-Faceted Nutrition Quality Improvement Program
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.
- Conditions
- Malnutrition (Calorie)
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Household | Includes eligible Children and their Caregivers | |
| Organization | NGO Staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline to 3, 6, 9, and 12 months
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: Baseline, 6, and 12 months
Nutrient Intake
Caregiver completed 24-hour dietary recall
Measured: Baseline, 3, 6, 9, and 12 months
Pediatric Nutrition Risk Status via Anthropometrics
Calculated from anthropometrics measurements as compared to established standards
Measured: Baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start11 May 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition (Calorie)Studies 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
- Prospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children International
- Responsible party
- Sponsor
- Investigators
- Amy Sharn, MS, RDN, LD, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524907
- Sponsor's protocol ID
- HA65
- Acronym
- STRIKE
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRIKE: Stunting and Targeting Reduction of Impaired Growth in Kids Effectively: A Community Engaged Comprehensive, Multi-Faceted Nutrition Quality Improvement Program
- ClinicalTrials.gov ID
- NCT07524907
- Acronym / sponsor ID
- STRIKE / HA65
- Conditions
- Malnutrition (Calorie)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Children International
- Study start
- 11 May 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Household | – | –Includes eligible Children and their Caregivers |
| Organization | – | –NGO Staff |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Via screening by existing community-based programming via Children International (NGO)
Key inclusion criteria (6 listed)
- Children aged 1-5 years experiencing stunting or its risk (defined as HAZ ≤ -1 SD at baseline)
- Children's legal guardian agrees to participate in the study
- Full term pregnancy (defined as ≥ 37 weeks gestation and ≥ 2500g birth weight)
- Residence in study area attending Children International (NGO) centers
- NGO staff taking part in nutrition screenings
Key exclusion criteria (14 listed)
- Children who have current medical conditions requiring hospitalization: gastrointestinal tract infections or inflammatory bowel disease; active tuberculosis; acute hepatitis B or C; human immunodeficiency virus OR malignancy; cystic fibrosis; immunodeficiency syndromes, congenital abnormalities of the respiratory tract, such as lung and respiratory cilia; an unsuspected foreign body in the respiratory tract; asthma; heart abnormalities; abdominal hernias; and known metabolic disorders, renal impairment, or rheumatic diseases and diabetes
- Congenital condition
- Children with disabilities such as cerebral palsy, autism spectrum disorder, neurodegenerative disorders
- Children with chronic or acute infections e.g. HIV, malaria
- Children who are taking medications or other agents that could potentially affect body weight, including diuretics, appetite stimulants, steroids, and growth hormones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Program Feasibility
Time frame: Baseline to 12 months
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
Growth Anthropometrics
Time frame: Baseline to 3, 6, 9, and 12 months
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)
5 secondary outcomes
Healthcare Resource Utilization
Time frame: Baseline, 6 and 12 months
Pediatric Quality of Life Inventory
Time frame: Baseline, 6, and 12 months
World Health Organization Quality of Life Brief Version
Time frame: Baseline, 6, and 12 months
Nutrient Intake
Time frame: Baseline, 3, 6, 9, and 12 months
Pediatric Nutrition Risk Status via Anthropometrics
Time frame: Baseline, 3, 6, 9, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- 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.
Amy Sharn, MS, RDN, LD study chair
Abbott
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 Malnutrition (Calorie), run by Abbott Nutrition 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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Becherer Children International (207-592-4917, cbecherer@children.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Feasibility (time frame: Baseline to 12 months). The study lists 2 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 24 Jul 2026.