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.

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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.

Figure 1 depicts the three key questions (KQs) and the research approach that will guide the review described in the research plan. On the left, the populations of interest are specified as pregnant women with normal and high BMI and women who are overweight or obese planning a pregnancy. From left to right, the figure illustrates the overarching question (KQ 1): do interventions to limit excess gestational weight gain lead to improved health outcomes in the populations of interest? The figure then depicts the pathway from the population to intermediate health outcomes, asking: do interventions to limit excess gestational weight gain lead to reduced gestational weight gain, postpartum weight retention, or obesity-related adverse perinatal conditions in the populations of interest (KQ 2)? The framework also asks: what are the harms of interventions to limit excess gestational weight gain in the populations of interest (KQ 3)?

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.

  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. 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).

Category Included Excluded
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
Interventions
  • Primary care–relevant interventions that aim to limit excess gestational weight gain or reduce prepregnancy weight and focus 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 clinicians, 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 print/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 (including stillbirth), maternal morbidity (e.g., postpartum hemorrhage, perineal trauma, depression), infant morbidity (e.g., birth trauma, shoulder dystocia, respiratory distress syndrome)

KQ 2:

  • Weight outcomes: preconception weight loss (kilograms or BMI), excessive gestational weight gain (based on Institute of Medicine recommendations or as described by study authors), measured gestational weight gain (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), 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.