Final Research Plan
Healthy Weight and Weight Gain In Pregnancy: Behavioral Counseling Interventions
July 26, 2018
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.
The final Research Plan is 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.
The draft Research Plan was available for comment from April 26 to May 23, 2018.
Abbreviations: BMI=body mass index; GWG=gestational weight gain.
1. a. Do interventions to limit excess gestational weight gain improve health outcomes among pregnant women and their infants?
b. Do interventions to reduce prepregnancy weight in women who are overweight or obese improve health outcomes among women who become pregnant and their infants?
c. Does the effectiveness of these interventions differ by age, race/ethnicity, socioeconomic status, parity, smoking status, or body mass index (BMI) category?
2. a. Do interventions to limit excess gestational weight gain reduce 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 improve weight outcomes or reduce 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, parity, smoking status, or BMI category?
3. a. What are the harms of interventions to limit excess gestational weight gain among pregnant women and their infants?
b. What are the harms of interventions to reduce prepregnancy weight among women or who are overweight or obese?
c. Do the harms of these interventions differ by age, race/ethnicity, socioeconomic status, parity, smoking status, or BMI category?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the association between gestational weight gain and adverse maternal and infant outcomes?
- What is the association between high prepregnancy BMI and risk of adverse maternal and infant outcomes?
- Among women with a high prepregnancy BMI, what is the association between reduction in prepregnancy weight and risk of adverse maternal and infant outcomes?
The 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).
|Populations||Pregnant women with normal and high BMI and women who are overweight or obese (defined by BMI) and planning pregnancy, including adolescents and adults||Studies limited to pregnant women with gestational diabetes mellitus; women with pre-existing diabetes|
||Pharmacologic interventions; broader community-based programs (e.g., mass media, changes to the community-built environment)|
||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 (including stillbirth), maternal morbidity (e.g., postpartum hemorrhage, perineal trauma, depression), infant morbidity (e.g., birth trauma, shoulder dystocia, respiratory distress syndrome)
KQ 3: Harms associated with interventions, (e.g., anxiety, stigma, maternal musculoskeletal injuries), harms related to insufficient weight gain (e.g., small for gestational age infants)
|KQ 1: Behavioral changes (e.g., physical activity level)
KQ 2: Cardiometabolic measures (e.g., glucose level, blood pressure, lipid level)
|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 countries not categorized as “Very High” on the 2016 Human Development Index|
|Study designs||KQs 1–3: Controlled clinical trials
KQ 3: 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.
The draft Research Plan was posted for public comment on the USPSTF Web site from April 26, 2018 to May 23, 2018. The USPSTF received minor comments related to the included populations and outcomes. In response to these comments, the USPSTF added parity and smoking status to the included subpopulations for KQs 1c, 2c, and 3c. In addition, the USPSTF revised the list of eligible outcomes for KQ 1 to clarify that stillbirth, depression, and shoulder dystocia are included. Finally, the USPSTF revised the list of eligible outcomes for KQ 3 to clarify that harms related to insufficient weight gain among infants are included.