Supplemental Evidence and Data Request on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our revi...
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
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:
epc@ahrq.hhs.gov.
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:
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.
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.
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.
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
( printed 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 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
• 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.
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)
• 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.
Comparator
• Consumption of different levels of total dietary digestible carbohydrate intake
• 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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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
• Outpatient; all settings except hospital and acute care will be included
• Narrative reviews.
• Systematic reviews.
• Meta-analyses.
• Scoping reviews.
• Umbrella reviews.
• Retrospective cohort studies.
• Cross-sectional studies.
• Case-control studies.
• All other study designs.
Geographic Location
• 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
• Locations not rated high or very high on the HDI.
Study Size
• Studies with N ≥30 participants (for randomized clinical trials [RCTs]): ≥10 participants analyzed
per study arm)
• Studies with N <30 participants (for RCTs: <10 participants analyzed
per study arm), and without power calculation.
Language
• Articles published in English
• Articles published in languages other than English.
Publication Dates
• Articles published during or after 2000
• 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.
Use this for formal legal and research references to the published document.
89 FR 44988
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Supplemental Evidence and Data Request on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review,” thefederalregister.org (May 22, 2024), https://thefederalregister.org/documents/2024-11198/supplemental-evidence-and-data-request-on-digestible-carbohydrate-intake-and-maternal-infant-outcomes-a-systematic-revie.