# 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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:
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 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?
| | | |
| --- | --- | --- |
| Population | | |
| | • Pregnant individuals and newborns not affected by a disease or health-related condition that impacts carbohydrate absorption and/or metabolism | • Non-human participants (
animal studies, in-vitro models). |
| Intervention (Exposure) | • Studies that report total dietary digestible carbohydrate intake
from foods, beverages, and dietary supplements
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) | • Studies that do not specify the amount of total digestible carbohydrate intake (
studies that only report type or source of digestible carbohydrate or report only total carbohydrate, but not 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. |
| Outcome | | |
| Timing | • All exposure or intervention durations will be included. | |
| Setting | • Outpatient; all settings except hospital and acute care will be included | • Hospital and acute care. |
| Study Design | • Randomized controlled trials. | • Narrative reviews. |
| 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) | • 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
) | • Studies with N <30 participants (for RCTs: <10 participants analyzed
), 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. |
Dated: May 16, 2024.
Mamatha Pancholi,
Deputy Director.