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Draft Research Plan

Draft Research Plan for Healthy Weight and Weight Gain During Pregnancy: Counseling

This opportunity for public comment expired on May 23, 2018 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

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Draft: Proposed Analytic Framework

Behavorial Counseling Interventions for Obesity in Pregnant Women, July 2019

Abbreviations: BMI=body mass index; GWG=gestational weight gain.

Draft: Proposed Key Questions to Be Systematically Reviewed

1. a. Do interventions to limit excess gestational weight gain lead to improved health outcomes among pregnant women and their infants?
    b. Do interventions to reduce prepregnancy weight in women who are overweight or obese lead to improved health outcomes among women who become pregnant and their infants?
    c. Does the effectiveness of these interventions differ by age, race/ethnicity, socioeconomic status, or body mass index (BMI) category?
2. a. Do interventions to limit excess gestational weight gain lead to reduced gestational weight gain, postpartum weight retention, or obesity-related adverse perinatal conditions among pregnant women and their infants?
    b. Do interventions to reduce prepregnancy weight in women who are overweight or obese lead to improved weight outcomes or reduced obesity-related adverse perinatal conditions among women who become pregnant and their infants?
    c. Does the effectiveness of these interventions differ by age, race/ethnicity, socioeconomic status, or BMI category?
3. a. What are the harms of interventions to limit excess gestational weight gain in pregnant women and their infants?
    b. What are the harms of interventions to reduce prepregnancy weight in women or who are overweight or obese?
    c. Do the harms of these interventions differ by age, race/ethnicity, socioeconomic status, or BMI category?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the association between gestational weight gain and adverse maternal and infant outcomes?
  2. What is the association between high prepregnancy BMI and risk of adverse maternal and infant outcomes?
  3. What is the association between reduction in prepregnancy weight and risk of adverse maternal and infant outcomes among women with a high prepregnancy BMI?

Draft: Proposed Research Approach

The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

Category Included Excluded
Populations Pregnant women with normal and high BMI and women who are overweight or obese (defined by BMI) planning pregnancy, including adults and adolescents Studies limited to pregnant women with gestational diabetes mellitus
Interventions
  • Primary care–relevant interventions that aim to limit excess gestational weight gain or reduce prepregnancy weight focusing on one or more of the following: diet, exercise, or behavioral counseling
  • Interventions may be delivered via face-to-face contact, telephone, print materials, or technology (e.g., computer-based, text messages) and can be delivered by numerous potential providers, including but not limited to physicians, nurses, exercise specialists, dietitians, nutritionists, and behavioral health specialists
Pharmacologic interventions; broader community-based programs (e.g., mass media, changes to the community-built environment)
Comparisons
  • No treatment (e.g., wait-list control, usual care)
  • Attention control (e.g., similar format and intensity to intervention but different content area)
  • Minimal intervention (including the use of generic printed/electronic communications)
Active comparators without a control group (i.e., head-to-head comparison studies, comparisons of two active interventions as defined above)
Outcomes KQ 1: Maternal or infant mortality, maternal morbidity (e.g., postpartum hemorrhage, perineal trauma), infant morbidity (e.g., birth trauma, respiratory distress syndrome)

KQ 2:

  • Weight outcomes: preconception weight loss (in kilograms or BMI), excessive gestational weight gain (based on Institute of Medicine recommendations or as described by study authors), measured gestational weight gain (in kilograms or BMI), and maternal postpartum weight loss/retention
  • Incidence or prevalence of maternal obesity-related perinatal conditions (e.g., macrosomia, preterm birth, gestational diabetes mellitus, hypertension, cesarean delivery)

KQ 3: Harms associated with interventions, (e.g., anxiety, stigma, maternal musculoskeletal injuries, small for gestational age infants)

KQ 1: Behavioral changes (e.g., physical activity level)

KQ 2: Cardiometabolic measures (e.g., glucose levels, blood pressure, lipid levels)
Countries Studies conducted in countries categorized as “Very High” on the 2016 Human Development Index (as defined by the United Nations Development Programme) Studies conducted in other country settings
Study designs KQs 1–2: Controlled clinical trials

KQ 3: Controlled clinical trials; cohort or case-control studies reporting harms related to interventions to reduce gestational weight gain and prepregnancy weight are also eligible
All other study designs*
Settings Studies conducted in or recruited from primary care or a health care system or studies that could feasibly be implemented in or referred from primary care  
Publication language English All other languages
Study quality Fair or good Poor (according to design-specific USPSTF criteria)

*Systematic reviews will be excluded from the evidence review. However, separate searches will be conducted to identify relevant systematic reviews, and the citations of all studies included in those systematic reviews will be reviewed to ensure that the database searches have captured all relevant primary studies.

Current as of: April 2018

Internet Citation: Draft Research Plan: Healthy Weight and Weight Gain During Pregnancy: Counseling . U.S. Preventive Services Task Force. April 2018.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/healthy-weight-and-weight-gain-during-pregnancy-behavorial-counseling-interventions

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