Supplemental Evidence and Data Request on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review, 44988-44990 [2024-11198]
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44988
Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
agenda, roster, and minutes will be
available from Jenny Griffith, Committee
Management Officer, Agency for
Healthcare Research and Quality, 5600
Fishers Lane, Rockville, Maryland,
20857. Jenny Griffith’s phone number is
(240) 446–6799.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Purpose
In accordance with the Federal
Advisory Committee Act, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality (the Council). 5
U.S.C. 1009. The Council is authorized
by section 941 of the Public Health
Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director of AHRQ on
matters related to AHRQ’s conduct of its
mission including providing guidance
on (A) priorities for health care research,
(B) the field of health care research
including training needs and
information dissemination on health
care quality and (C) the role of the
Agency in light of private sector activity
and opportunities for public private
partnerships. The Council is composed
of members of the public, appointed by
the Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
II. Agenda
On Friday, June 28, NAC members
will meet to conduct preparatory work
prior to convening the Council meeting
at 1:45 p.m., with the call to order by
the Council Chair, an introduction of
NAC members, and approval of
previous Council summary notes. The
NAC members will then receive an
update from the AHRQ Director. The
agenda will also include a conversation
on the vision for Health Services
Research, as well as an update on the
Age-Friendly Healthcare Systems
Strategic Plan, to be followed by a
discussion about opportunities for
modernizing the measurement of
consumer experience. On Saturday,
June 29, NAC members will convene the
Council meeting at 9:00 a.m. with
welcome and call to order. The NAC
members will then discuss priority
populations and maternity health, as
well as listen to an update on AHRQ’s
Patient-Centered Outcomes Research
Trust Fund (PCORTF) Extension
Program. For information regarding how
to access the meeting as well as other
meeting details, including information
on how to make a public comment,
please go to https://www.ahrq.gov/news/
events/nac/. The final agenda will be
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available on the AHRQ website no later
than Thursday, June 14, 2024.
Systematic Review. AHRQ is conducting
this review pursuant to section 902 of
the Public Health Service Act, 42 U.S.C.
Dated: May 3, 2024.
299a.
Mamatha Pancholi,
The EPC Program is dedicated to
Deputy Director.
identifying as many studies as possible
[FR Doc. 2024–11200 Filed 5–21–24; 8:45 am]
that are relevant to the questions for
BILLING CODE P
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
DEPARTMENT OF HEALTH AND
literature by requesting information
HUMAN SERVICES
from the public (e.g., details of studies
conducted). We are looking for studies
Agency for Healthcare Research and
that report on Digestible Carbohydrate
Quality
Intake and Maternal-Infant Outcomes: A
Systematic Review. The entire research
Supplemental Evidence and Data
protocol is available online at: https://
Request on Digestible Carbohydrate
effectivehealthcare.ahrq.gov/products/
Intake and Maternal-Infant Outcomes:
carbohydrate-intake/protocol. This is to
A Systematic Review
notify the public that the EPC Program
AGENCY: Agency for Healthcare Research would find the following information on
and Quality (AHRQ), HHS.
Digestible Carbohydrate Intake and
Maternal-Infant Outcomes: A
ACTION: Request for supplemental
Systematic Review helpful:
evidence and data submission.
D A list of completed studies that
SUMMARY: The Agency for Healthcare
your organization has sponsored for this
Research and Quality (AHRQ) is seeking topic. In the list, please indicate
scientific information submissions from whether results are available on
the public. Scientific information is
ClinicalTrials.gov along with the
being solicited to inform our review on
ClinicalTrials.gov trial number.
D For completed studies that do not
Digestible Carbohydrate Intake and
have results on ClinicalTrials.gov, a
Maternal-Infant Outcomes: A
summary, including the following
Systematic Review, which is currently
elements, if relevant: study number,
being conducted by the AHRQ’s
study period, design, methodology,
Evidence-based Practice Centers (EPC)
indication and diagnosis, proper use
Program. Access to published and
instructions, inclusion and exclusion
unpublished pertinent scientific
criteria, primary and secondary
information will improve the quality of
outcomes, baseline characteristics,
this review.
number of patients screened/eligible/
DATES: Submission Deadline on or
enrolled/lost to follow-up/withdrawn/
before June 21, 2024.
analyzed, effectiveness/efficacy, and
ADDRESSES:
safety results.
Email submissions: epc@
D A list of ongoing studies that your
ahrq.hhs.gov.
organization
has sponsored for this
Print submissions:
topic. In the list, please provide the
Mailing Address: Center for Evidence
ClinicalTrials.gov trial number or, if the
and Practice Improvement, Agency for trial is not registered, the protocol for
Healthcare Research and Quality,
the study including, if relevant, a study
ATTN: EPC SEADs Coordinator, 5600 number, the study period, design,
Fishers Lane, Mail Stop 06E53A,
methodology, indication and diagnosis,
Rockville, MD 20857
proper use instructions, inclusion and
Shipping Address (FedEx, UPS, etc.):
exclusion criteria, and primary and
Center for Evidence and Practice
secondary outcomes.
Improvement, Agency for Healthcare
D Description of whether the above
Research and Quality, ATTN: EPC
studies constitute ALL Phase II and
SEADs Coordinator, 5600 Fishers
above clinical trials sponsored by your
Lane, Mail Stop 06E77D, Rockville,
organization for this topic and an index
MD 20857
outlining the relevant information in
FOR FURTHER INFORMATION CONTACT:
each submitted file.
Kelly Carper, Telephone: 301–427–1656
Your contribution is very beneficial to
or email: epc@ahrq.hhs.gov.
the Program. Materials submitted must
be publicly available or able to be made
SUPPLEMENTARY INFORMATION: The
public. Materials that are considered
Agency for Healthcare Research and
confidential; marketing materials; study
Quality has commissioned the
types not included in the review; or
Evidence-based Practice Centers (EPC)
information on topics not included in
Program to complete a review of the
the review cannot be used by the EPC
evidence for Digestible Carbohydrate
Intake and Maternal-Infant Outcomes: A Program. This is a voluntary request for
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Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
information, and all costs for complying
with this request must be borne by the
submitter.
as background. AHRQ is not requesting
that the public provide answers to these
questions.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://effectivehealthcare.ahrq.gov/
email-updates.
Key Questions (KQ)
The review will answer the following
questions. This information is provided
1. What is the association between
dietary digestible carbohydrate intake
by a person during pregnancy and the
weight, length, head circumference, and
other measures of size and body
composition of the infant obtained at
birth? How are these associations
affected by characteristics of the
pregnant person?
44989
2. What is the association between
dietary digestible carbohydrate intake
during pregnancy and gestational
weight gain? How are these associations
affected by characteristics of the
pregnant person?
3. What is the association between
infant dietary digestible carbohydrate
intake, including digestible
carbohydrate intake from human milk,
and measures of growth, size, and body
composition in individuals from birth to
24 months of age?
khammond on DSKJM1Z7X2PROD with NOTICES
INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY
DESIGN (PICOTS)
Element
Inclusion criteria
Exclusion criteria
Population ..................................
KQ1 and KQ2: ...............................................................................
• Pregnant individuals and newborns not affected by a disease or health-related condition that impacts carbohydrate absorption and/or metabolism.
KQ3:
• Infants from birth to 24 months of age not affected by a disease or health-related condition that impacts carbohydrate absorption and/or metabolism.
Intervention (Exposure) .............
• Studies that report total dietary digestible carbohydrate intakea from foods, beverages, and dietary supplementsb or report
values that allow total digestible carbohydrate intake to be calculated, and percentage of dietary intake consisting of total dietary carbohydrate with or without the % from other
macronutrients (protein and fat).
• A dietary pattern that describes and quantifies intake of
total dietary digestible carbohydrate and total energy intake, with
or without total fat, and total dietary protein content (e.g., low/
high-fat diet; low/high-carbohydrate diet; high-protein; ketogenic
diet; Atkins diet; Zone diet; Pritikin diet; Ornish diet).
Comparator ................................
• Consumption of different levels of total dietary digestible
carbohydrate intake.
All KQs:
• Non-human participants (e.g., animal studies, in-vitro models).
• Studies that enroll participants with diseases/health-related
conditions that impact carbohydrate absorption or metabolism
(e.g., cancer, malabsorption syndromes, diabetes).
• Studies that exclusively enroll participants hospitalized with
(1) an illness or injury; or (2) undernourished, underweight,
stunted, or wasted participants.
• Studies designed to induce weight loss or treat overweight
and obesity through energy restriction or hypocaloric diets for
the purposes of treating additional or other medical conditions.
KQ1 and KQ2:
• Individuals who are not pregnant.
• Studies that enroll participants that are pre- or post-bariatric
surgery.
KQ3
• Children older than 24 months of age.
• Studies of exclusively pre-term babies (gestational age <37
weeks), exclusively babies that have low birth weight (<2500g)
and/or exclusively babies that are small for gestational age.
• Studies that do not specify the amount of total digestible
carbohydrate intake (e.g., studies that only report type or source
of digestible carbohydrate or report only total carbohydrate, but
not digestible carbohydrate).
• Studies that do not provide percentage of dietary intake
from total digestible carbohydrates or enough data to allow this
to be calculated.
• Studies that only assess digestible carbohydrate intake via
infusions.
• Studies that only assess exposure to digestible carbohydrate from a single meal or eating occasion such that usual
intake cannot be inferred.
• Studies that examine food products or dietary supplements
not widely available to U.S. and/or Canadian consumers.
• Multi-component interventions that do not isolate the effect
of, or association with, digestible carbohydrate.
• Studies that do not attempt to control for energy intake of
participants such that comparisons are not made on an
isocaloric basis. Comparisons of digestible carbohydrate exposure should not be confounded by differences in participants’
energy intake.
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Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY
DESIGN (PICOTS)—Continued
Element
Inclusion criteria
Outcome ....................................
KQ1:
Newborn size and body composition.
• Birth weight, weight-for-age and percentile or Z-score adjusted for gestational age.
• Low birth weight.
• Small-for-gestational age.
• Large-for-gestational age; fetal macrosomia.
• Birth length, length-for-age and percentile and Z-score adjusted for gestational age.
• Head circumference and percentile and Z-score adjusted
for gestational age.
• BMI, BMI z-score, weight-for-length percentile, and Z-score
• Ponderal index or other composite measures.
• Body composition and distribution (e.g., % fat mass, fat-free
mass, skin fold thicknesses, circumferences).
KQ2:
Gestational weight gain.
• Change in pregnant individual’s body weight from baseline
(before or during 1st trimester of pregnancy) to a later time point
during pregnancy and/or right before delivery.
• Weight gain in relationship to weight gain recommendations, based on pre-pregnancy BMI.
KQ3:
Infant (up to 24 months of age) growth, size, and body composition.
• Weight-for-age and percentile or Z-score adjusted for gestational age.
• Length-for-age and percentile and Z-score adjusted for gestational age.
• Head circumference and percentile and Z-score adjusted
for gestational age.
• BMI, BMI z-score, weight-for-length percentile, and Z-score
• Body composition and distribution (e.g., % fat mass, fat-free
mass, skin fold thicknesses, circumferences).
• Incidence and prevalence of underweight, failure to thrive,
stunting, wasting, healthy weight, overweight, obesity.
• All exposure or intervention durations will be included.
• KQ1 and KQ2: exposure during pregnancy.
• KQ3: exposure from birth to 24 months of age.
• Outpatient; all settings except hospital and acute care will
be included.
• Randomized controlled trials.
• Non-randomized controlled trials, including quasi-experimental and controlled before-and-after studies.
• Prospective cohort studies.
• Nested case-control studies.
Timing ........................................
Setting ........................................
Study Design .............................
Geographic Location .................
Study Size .................................
Language ...................................
Publication Dates .......................
Exclusion criteria
• Locations with food products or dietary supplements widely
available to U.S. and/or Canadian consumers, including those
rated high and very high on the Human Development Index
(HDI)c.
• Studies with N ≥30 participants (for randomized clinical
trials [RCTs]): ≥10 participants analyzed per study arm).
• Articles published in English ..................................................
• Articles published during or after 2000 ..................................
• Hospital and acute care.
•
•
•
•
•
•
•
•
•
•
Narrative reviews.
Systematic reviews.
Meta-analyses.
Scoping reviews.
Umbrella reviews.
Retrospective cohort studies.
Cross-sectional studies.
Case-control studies.
All other study designs.
Locations not rated high or very high on the HDI.
• Studies with N <30 participants (for RCTs: <10 participants
analyzed per study arm), and without power calculation.
• Articles published in languages other than English.
• Articles published prior to 2000.
a Total
dietary digestible carbohydrate intake defined as collective starch and sugar intake; carbohydrate intake not including dietary fiber.
b Dietary supplement is defined as a product intended to supplement the diet that contains one or more dietary ingredients (including vitamins, minerals, herbs or
other botanicals, amino acids, and other substances) intended to be taken by mouth as a pill, capsule, table, or liquid, and that is labeled on the front panel as being
a dietary supplement.
c United Nations Development Programme Human Development Reports, https://hdr.undp.org/data-center/human-development-index#/indicies/HDI.
Dated: May 16, 2024.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024–11198 Filed 5–21–24; 8:45 am]
Administration for Children and
Families
BILLING CODE 4160–90–P
khammond on DSKJM1Z7X2PROD with NOTICES
Privacy Act of 1974; System of
Records; Correction
Administration for Children
and Families, Department of Health and
Human Services.
AGENCY:
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ACTION:
Notice; Correction.
The Department of Health and
Human Services (HHS) published a
system of records notice in the Federal
Register on May 16, 2024, for new
system of records ‘‘OCSS Research
Platform’’ maintained by HHS’
Administration for Children and
Families (ACF), Office of Child Support
Services (OCSS). The notice contained
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44988-44990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11198]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Digestible Carbohydrate
Intake and Maternal-Infant Outcomes: A Systematic Review
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Digestible
Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review,
which is currently being conducted by the AHRQ's Evidence-based
Practice Centers (EPC) Program. Access to published and unpublished
pertinent scientific information will improve the quality of this
review.
DATES: Submission Deadline on or before June 21, 2024.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Digestible
Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review.
AHRQ is conducting this review pursuant to section 902 of the Public
Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Digestible Carbohydrate Intake and Maternal-Infant
Outcomes: A Systematic Review. The entire research protocol is
available online at: https://effectivehealthcare.ahrq.gov/products/carbohydrate-intake/protocol. This is to notify the public that the EPC
Program would find the following information on Digestible Carbohydrate
Intake and Maternal-Infant Outcomes: A Systematic Review helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. In the list, please indicate whether results
are available on ClinicalTrials.gov along with the ClinicalTrials.gov
trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements, if
relevant: study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on topics not included
in the review cannot be used by the EPC Program. This is a voluntary
request for
[[Page 44989]]
information, and all costs for complying with this request must be
borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
1. What is the association between dietary digestible carbohydrate
intake by a person during pregnancy and the weight, length, head
circumference, and other measures of size and body composition of the
infant obtained at birth? How are these associations affected by
characteristics of the pregnant person?
2. What is the association between dietary digestible carbohydrate
intake during pregnancy and gestational weight gain? How are these
associations affected by characteristics of the pregnant person?
3. What is the association between infant dietary digestible
carbohydrate intake, including digestible carbohydrate intake from
human milk, and measures of growth, size, and body composition in
individuals from birth to 24 months of age?
Inclusion and Exclusion Criteria by Population, Intervention,
Comparator, Outcome, Timing, Setting/Study Design (PICOTS)
------------------------------------------------------------------------
Element Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population.................. KQ1 and KQ2:........ All KQs:
Pregnant Non-human
individuals and participants (e.g.,
newborns not animal studies, in-
affected by a vitro models).
disease or health- Studies
related condition that enroll
that impacts participants with
carbohydrate diseases/health-
absorption and/or related conditions
metabolism that impact
KQ3:................ carbohydrate
Infants absorption or
from birth to 24 metabolism (e.g.,
months of age not cancer,
affected by a malabsorption
disease or health- syndromes,
related condition diabetes).
that impacts Studies
carbohydrate that exclusively
absorption and/or enroll participants
metabolism. hospitalized with
(1) an illness or
injury; or (2)
undernourished,
underweight,
stunted, or wasted
participants.
Studies
designed to induce
weight loss or
treat overweight
and obesity through
energy restriction
or hypocaloric
diets for the
purposes of
treating additional
or other medical
conditions.
KQ1 and KQ2:
Individuals
who are not
pregnant.
Studies
that enroll
participants that
are pre- or post-
bariatric surgery.
KQ3
Children
older than 24
months of age.
Studies of
exclusively pre-
term babies
(gestational age
<37 weeks),
exclusively babies
that have low birth
weight (<2500g) and/
or exclusively
babies that are
small for
gestational age.
Intervention (Exposure)..... Studies Studies
that report total that do not specify
dietary digestible the amount of total
carbohydrate digestible
intake\a\ from carbohydrate intake
foods, beverages, (e.g., studies that
and dietary only report type or
supplements\b\ or source of digestible
report values that carbohydrate or
allow total report only total
digestible carbohydrate, but
carbohydrate intake not digestible
to be calculated, carbohydrate).
and percentage of Studies
dietary intake that do not provide
consisting of total percentage of
dietary carbohydrate dietary intake from
with or without the total digestible
% from other carbohydrates or
macronutrients enough data to
(protein and fat) allow this to be
A dietary calculated.
pattern that Studies
describes and that only assess
quantifies intake digestible
of total dietary carbohydrate intake
digestible via infusions.
carbohydrate and Studies
total energy that only assess
intake, with or exposure to
without total fat, digestible
and total dietary carbohydrate from a
protein content single meal or
(e.g., low/high-fat eating occasion
diet; low/high- such that usual
carbohydrate diet; intake cannot be
high-protein; inferred.
ketogenic diet; Studies
Atkins diet; Zone that examine food
diet; Pritikin products or dietary
diet; Ornish diet). supplements not
widely available to
U.S. and/or
Canadian consumers.
Multi-
component
interventions that
do not isolate the
effect of, or
association with,
digestible
carbohydrate.
Comparator.................. Studies
Consumption of that do not attempt
different levels of to control for
total dietary energy intake of
digestible participants such
carbohydrate intake that comparisons are
not made on an
isocaloric basis.
Comparisons of
digestible
carbohydrate
exposure should not
be confounded by
differences in
participants' energy
intake.
[[Page 44990]]
Outcome..................... KQ1:
Newborn size and
body composition..
Birth
weight, weight-for-
age and percentile
or Z-score adjusted
for gestational age.
Low birth
weight..
Small-for-
gestational age..
Large-for-
gestational age;
fetal macrosomia..
Birth
length, length-for-
age and percentile
and Z-score
adjusted for
gestational age.
Head
circumference and
percentile and Z-
score adjusted for
gestational age.
BMI, BMI z-
score, weight-for-
length percentile,
and Z-score.
Ponderal
index or other
composite measures..
Body
composition and
distribution (e.g.,
% fat mass, fat-
free mass, skin
fold thicknesses,
circumferences).
KQ2:................
Gestational weight
gain..
Change in
pregnant
individual's body
weight from
baseline (before or
during 1st
trimester of
pregnancy) to a
later time point
during pregnancy
and/or right before
delivery.
Weight gain
in relationship to
weight gain
recommendations,
based on pre-
pregnancy BMI.
KQ3:................
Infant (up to 24
months of age)
growth, size, and
body composition.
Weight-for-
age and percentile
or Z-score adjusted
for gestational age.
Length-for-
age and percentile
and Z-score
adjusted for
gestational age.
Head
circumference and
percentile and Z-
score adjusted for
gestational age.
BMI, BMI z-
score, weight-for-
length percentile,
and Z-score.
Body
composition and
distribution (e.g.,
% fat mass, fat-
free mass, skin
fold thicknesses,
circumferences).
Incidence
and prevalence of
underweight,
failure to thrive,
stunting, wasting,
healthy weight,
overweight, obesity.
Timing...................... All
exposure or
intervention
durations will be
included.
KQ1 and
KQ2: exposure
during pregnancy..
KQ3:
exposure from birth
to 24 months of
age..
Setting..................... Hospital
Outpatient; all and acute care.
settings except
hospital and acute
care will be
included
Study Design................ Randomized Narrative
controlled trials. reviews.
Non- Systematic
randomized reviews.
controlled trials, Meta-
including quasi- analyses.
experimental and Scoping
controlled before- reviews.
and-after studies. Umbrella
reviews.
Prospective cohort
studies.. Retrospective
Nested cohort studies.
case-control Cross-
studies.. sectional studies.
Case-
control studies.
All other
study designs.
Geographic Location......... Locations Locations
with food products not rated high or
or dietary very high on the
supplements widely HDI.
available to U.S.
and/or Canadian
consumers, including
those rated high and
very high on the
Human Development
Index (HDI)\c\
Study Size.................. Studies Studies
with N >=30 with N <30
participants (for participants (for
randomized clinical RCTs: <10
trials [RCTs]): >=10 participants
participants analyzed per study
analyzed per study arm), and without
arm) power calculation.
Language.................... Articles Articles
published in English published in
languages other than
English.
Publication Dates........... Articles Articles
published during or published prior to
after 2000 2000.
------------------------------------------------------------------------
\a\ Total dietary digestible carbohydrate intake defined as collective
starch and sugar intake; carbohydrate intake not including dietary
fiber.
\b\ Dietary supplement is defined as a product intended to supplement
the diet that contains one or more dietary ingredients (including
vitamins, minerals, herbs or other botanicals, amino acids, and other
substances) intended to be taken by mouth as a pill, capsule, table,
or liquid, and that is labeled on the front panel as being a dietary
supplement.
\c\ United Nations Development Programme Human Development Reports,
https://hdr.undp.org/data-center/human-development-index#/indicies/HDI HDI.
Dated: May 16, 2024.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024-11198 Filed 5-21-24; 8:45 am]
BILLING CODE 4160-90-P
