Moderate Acute Malnutrition (MAM)NCT02572258
Supplementary Food on Prevention of Moderate Malnutrition in Children
A study testing Nutritional cookie in people with Moderate Acute Malnutrition (MAM), run by PepsiCo Global R&D at 1 site in Mexico.
Trial summary
The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Moderate Acute Malnutrition (MAM)
- What is being tested?
- Nutritional cookie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,048 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2015to Sep 2017
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (2-5 years old), who are from low socioeconomic classes (E and D classes)
- reside in rural areas, and with WHZ- between > -3 and ≤ -2, and
- informed consent given by the subject's mother or caregiver
Who cannot join
- Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
- Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
- (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
- Current consumption of other supplementary foods.
- Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico
The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.
Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months
- Conditions
- Moderate Acute Malnutrition (MAM)
- Being tested
- Nutritional cookie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional cookieOther
| Study group | Role | What they receive |
|---|---|---|
| Nutritional oats cookie and educational session | Experimental | Nutritional cookie with oats and nuts Receives: Other: Nutritional cookie |
| Educational session only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg) for height (cm) Z-score
Measured: 12 months
Secondary outcomes (5)
Weight (kg) gains
Measured: 12 months
height (cm) for age (months) Z-score
Measured: 12 months
weight (kg) for age (months) Z-score
Measured: 12 months
Mid-upper arm circumference (cm) (MUAC)
Measured: 12 months
height (cm) gains
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Acute Malnutrition (MAM)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Talavera, PhD, Principal investigator, Universidad Autónoma del Estado de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572258
- Sponsor's protocol ID
- PEP-1410
- Status last verified
- Sep 2018
- First submitted
- 29 Sep 2015
- Last updated
- 27 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico
- ClinicalTrials.gov ID
- NCT02572258
- Acronym / sponsor ID
- PEP-1410
- Conditions
- Moderate Acute Malnutrition (MAM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,048 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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 study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.
Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional oats cookie and educational session | Experimental | Other: Nutritional cookieNutritional cookie with oats and nuts |
| Educational session only | No intervention | – |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- (2-5 years old), who are from low socioeconomic classes (E and D classes)
- reside in rural areas, and with WHZ- between > -3 and ≤ -2, and
- informed consent given by the subject's mother or caregiver
Key exclusion criteria (5 listed)
- Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
- Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
- (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
- Current consumption of other supplementary foods.
- Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.
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 |
|---|---|---|
| Nutritional cookie | Other | Nutritional oats cookie and educational session |
Primary outcome
Weight (kg) for height (cm) Z-score
Time frame: 12 months
5 secondary outcomes
Weight (kg) gains
Time frame: 12 months
height (cm) for age (months) Z-score
Time frame: 12 months
weight (kg) for age (months) Z-score
Time frame: 12 months
Mid-upper arm circumference (cm) (MUAC)
Time frame: 12 months
height (cm) gains
Time frame: 12 months
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 27 Sep 2018.
Related trials for Moderate Acute Malnutrition (MAM)
Enrolling by invitation
Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
Moderate Acute Malnutrition (MAM), Undernutrition
Active, not recruiting
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
Severe Acute Malnutrition, Moderate Acute Malnutrition (MAM)
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.
Juan Talavera, PhD principal investigator
Universidad Autónoma del Estado de México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional cookie in people with Moderate Acute Malnutrition (MAM), run by PepsiCo Global R&D at 1 site in Mexico.
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 3 inclusion and 5 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 27 Sep 2018. 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 Mexico. 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?
Weight (kg) for height (cm) Z-score (time frame: 12 months). 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 27 Sep 2018.