Stunting and Targeting Reduction of Impaired Growth in Kids Effectively

ConditionMalnutrition (Calorie)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age1-5

SponsorAbbott Nutrition

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Via screening by existing community-based programming via Children International (NGO)

Trial design

Design model

Ecologic or community

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

158 Participants

are grouped into 2 trial groups

Group A: Household

Group B: Organization

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbott Nutrition

Lead sponsor

Children International

Collaborator

Source ClinicalTrials.gov

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