Childhood adiposity, serum metabolites and breast density in young women.

BACKGROUND: Childhood adiposity is inversely associated with young adult percent dense breast volume (%DBV) and absolute dense breast volume (ADBV), which could contribute to its protective effect for breast cancer later in life. The objective of this study was to identify metabolites in childhood serum that may mediate the inverse association between childhood adiposity and young adult breast density. METHODS: Longitudinal data from 182 female participants in the Dietary Intervention Study in Children (DISC) and the DISC 2006 (DISC06) Follow-Up Study were analyzed. Childhood adiposity was assessed by anthropometry at the DISC visit with serum available that occurred closest to menarche and expressed as a body mass index (BMI) z-score. Serum metabolites were measured by untargeted metabolomics using ultra-high-performance liquid chromatography-tandem mass spectrometry. %DBV and ADBV were measured by magnetic resonance imaging at the DISC06 visit when participants were 25-29 years old. Robust mixed effects linear regression was used to identify serum metabolites associated with childhood BMI z-scores and breast density, and the R package mediation was used to quantify mediation. RESULTS: Of the 115 metabolites associated with BMI z-scores (FDR < 0.20), 4 were significantly associated with %DBV and 6 with ADBV before, though not after, adjustment for multiple comparisons. Mediation analysis identified 2 unnamed metabolites, X-16576 and X-24588, as potential mediators of the inverse association between childhood adiposity and dense breast volume. X-16576 mediated 14% (95% confidence interval (CI) = 0.002, 0.46; P = 0.04) of the association of childhood adiposity with %DBV and 11% (95% CI = 0.01, 0.26; P = 0.02) of its association with ADBV. X-24588 also mediated 7% (95% CI = 0.001, 0.18; P = 0.05) of the association of childhood adiposity with ADBV. None of the other metabolites examined contributed to mediation of the childhood adiposity-%DBV association, though there was some support for contributions of lysine, valine and 7-methylguanine to mediation of the inverse association of childhood adiposity with ADBV. CONCLUSIONS: Additional large longitudinal studies are needed to identify metabolites and other biomarkers that mediate the inverse association of childhood adiposity with breast density and possibly breast cancer risk.

Prepare randomized clinical trial: Acceptability, engagement, and lifestyle effects of a weight loss intervention beginning in pre-pregnancy.

Background: Healthier lifestyles in early pregnancy are associated with lower rates of pregnancy complications, childhood adiposity, and maternal and child cardiovascular risks. However, it is not known whether lifestyle coaching initiated prior to pregnancy can affect behavior and attitudes during pregnancy. Methods: Three hundred and twenty six women planning pregnancy within 2 years with BMI ≥27 kg/m2 were randomized to a behavioral weight loss intervention or to usual care. Analyses reported here examined the intervention's impact on mid-pregnancy diet quality and activity levels; program acceptability; and effects of pregnancy on intervention engagement. Results: One hundred and sixty eight participants experienced pregnancy during the study (intervention: 91; usual care: 77). From randomization to mid-pregnancy, participants who received the intervention had larger increases in fruit intake than usual care participants (+0.67 vs. +0.06 cups; p = 0.02) and engaged in more vigorous-intensity activity (3.9 [5.5] vs. 1.2 [3.0] Met-hr/week p = 0.002) and sports/exercise (17.0 [14.1] vs. 11.0 [9.5] Met-hr/week; p = 0.03); the groups also differed in changes in sedentary time (-4.9 [15.0] vs. +0.5 [7.6] Met-hr/week; p = 0.02). Intervention satisfaction was high (>80%), and experiencing pregnancy during the intervention was associated with higher engagement. Conclusion: A coaching-based intervention beginning in pre-pregnancy successfully helped women attain healthier diet and exercise habits in mid-pregnancy. Clinical trials registration: Registered with ClinicalTrials.gov, NCT02346162, first registered on January 26, 2015, before date of initial participant enrollment (May 2015), https://clinicaltrials.gov/ct2/show/NCT02346162.

Costs and Cost-Effectiveness of Implementing a Digital Diabetes Prevention Program in a Large, Integrated Health System.

BackgroundThe Diabetes Prevention Program (DPP) has been translated into digital formats. We report an economic evaluation of a digital DPP implemented in a large, integrated health care system. MethodsPatients (n = 4148) were invited to participate in digital DPP based on clinical characteristics (HbA1c 5.7%-6.4% and body mass index ≥ 30 kg/m2) assessed using electronic medical record data. Using a propensity score we matched (1:1) enrolled and not enrolled patients for a total of 784. We identified high-risk patients (ie, above the 50th percentile of risk; n = 202) by calculating each patient's 2-year of developing diabetes. We report the cost of the intervention and the costs of medical care over 12- and 24-month follow-up, and the incremental cost-effectiveness ratio as the cost per additional kilogram weight loss at 24 months. ResultsAt 12 months, enrolled patients had lower total costs ($6,926, 95% CI $5,681-$8,171) than not enrolled patients ($7,538, 95% CI $6,293-$8,783). This pattern attenuated slightly at 24 months (enrolled = $16,255, 95% CI $14,097-$18,412; not enrolled = $16,688, 95% CI $14,531-$18,846). We found an incremental cost-effectiveness ratio of $81.92 per additional kilogram weight loss. For high-risk patients, the digital DPP group had, on average, lower costs and greater weight loss. We found a 55% chance of the digital DPP program being cost-effective at a willingness-to-pay of $150 per additional kilogram of weight loss; at the same willingness-to-pay, there is a 60% chance in the high-risk subgroup. Limitations include the nonrandomized design and potential volunteer bias. ConclusionDigital DPP had a favorable cost-effectiveness profile compared to other lifestyle interventions.

Evaluating the Implementation of a Digital Diabetes Prevention Program in an Integrated Health Care Delivery System Among Older Adults: Results of a Natural Experiment.

The purpose of this natural experiment study was to assess the effectiveness of a 12-month digital Diabetes Prevention Program (DPP) for adults aged 65-75 years with prediabetes and obesity within a large, integrated health care system. Adjusting for propensity scores and covariates, patients who enrolled and participated in the digital DPP had a mean weight loss of 8.6 lb over 12 months and 5.7 lb by 24 months, compared with a steady, minimal weight loss of 1.3 lb over 12 months and 2.8 lb by 24 months among patients not enrolled. There was a significant difference in mean change in A1C between enrolled and nonenrolled patients over 12 months (-0.10%), but not by 24 months (-0.06%). Digital DPP appears to be an effective weight loss option and potential diabetes prevention intervention for older adults at high risk for type 2 diabetes.

Weight Loss Prior to Pregnancy and Early Gestational Glycemia: Prepare, a Randomized Clinical Trial.

CONTEXT: Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of prepregnancy weight loss on risk of developing gestational diabetes. OBJECTIVE: This work aims to determine whether prepregnancy weight loss improved the early metabolic environment as measured by early gestational diabetes diagnosis. METHODS: This was a secondary analysis of a pragmatic randomized clinical trial conducted between May 2015 and October 2019 in an integrated health system that encouraged first-trimester gestational diabetes screening for high-risk women, including those with obesity. Women aged 18 to 40 years with a body mass index (BMI) greater than or equal to 27 who were planning pregnancy were randomly assigned to a behavioral weight loss intervention or usual care. Clinical care decisions and data collection were blind to condition assignment. We compared rates of diagnosis with gestational diabetes in early pregnancy between the groups using logistic regression. RESULTS: Of 326 participants, 168 (89 in the intervention and 79 in usual care) had singleton pregnancies during the study period. At baseline, mean age was 31.3 ±â€…3.5 years and BMI was 34.8 ±â€…5.8. Fifty-nine (66%) intervention participants and 57 (72%) usual care participants underwent early screening. Among those, intervention participants were 73% less likely to be diagnosed with gestational diabetes than usual care participants (adjusted odds ratio [aOR], 0.27; 95% CI, 0.09-0.80). There was no difference in diagnosis of gestational diabetes in later pregnancy (aOR, 1.08; 95% CI, 0.41-2.81). CONCLUSION: Participation in a prepregnancy weight loss intervention led to lower rates of gestational diabetes diagnosis in early pregnancy. This suggests positive effects of prepregnancy weight loss on the early metabolic environment, a critical factor in offspring metabolic risk.

Evaluating the Implementation of Digital and In-Person Diabetes Prevention Program in a Large, Integrated Health System: Natural Experiment Study Design.

INTRODUCTION: Implementation of a Diabetes Prevention Program (DPP) in both in-person and digital health-care settings has been increasing. The purpose of this article is to describe the protocol of a mixed-methods, natural experiment study designed to evaluate the implementation of DPP in a large, integrated health system. METHODS: Kaiser Permanente Northwest patients who were 19 to 75 years with prediabetes (hemoglobin A1c or glycated hemoglobin, 5.7-6.4) and obesity (body mass index ≥ 30 kg/m2) were invited, via the Kaiser Permanente Northwest patient portal, to participate in the digital (n = 4124) and in-person (n = 2669) DPP during 2016 through 2018. Primary (weight) and secondary (hemoglobin A1c or glycated hemoglobin level) outcome data will be obtained from electronic health records. A cost-effectiveness analysis as well as qualitative interviews with patients (enrolled and not enrolled in the DPP) and stakeholders will be conducted to examine further implementation, acceptability, and sustainability. CONCLUSION: The mixed-methods, natural experiment design we will use to evaluate Kaiser Permanente Northwest's implementation of the digital and in-person DPP builds on existing evidence related to the effectiveness of these two DPP delivery modes and will contribute new knowledge related to best practices for implementing and sustaining the DPP within large health systems over the long term.

Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial.

BACKGROUND: Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of prepregnancy weight loss on health outcomes. OBJECTIVE: This study aimed to determine whether prepregnancy weight loss reduces gestational weight gain and improves pregnancy outcomes. STUDY DESIGN: Pragmatic randomized clinical trial was conducted between May 2015 and October 2019 at Kaiser Permanente Northwest, an integrated health system. Data collection was blind to condition assignment. Eligible participants were women aged 18 to 40 years with a body mass index of ≥27 kg/m2 who were planning pregnancy within 2 years. Recruitment contacts were sent to 27,665 health system members who met age and body mass index criteria; 329 women attended screening visits, and 326 were randomized. They were randomized to either a behavioral weight loss intervention or usual care control. The intervention consisted of health coaching phone sessions weekly for 6 months and then monthly for 18 months or until end of pregnancy. We used logistic regression to examine the a priori primary hypothesis that participants in the intervention would be less likely to exceed National Academy of Medicine guidelines for gestational weight gain during each trimester and overall. Secondary and exploratory outcomes included absolute weight gain before and during pregnancy and perinatal and newborn outcomes. RESULTS: Of the 326 participants, 169 had singleton pregnancies lasting ≥14 weeks (analytical cohort: intervention, 89; control, 80). At baseline, mean age was 31.3±3.5 years, and body mass index was 34.8±5.8 kg/m2. Participants in the intervention group lost more weight before pregnancy than those in the control group (-0.25±0.51 vs -0.03±0.21 kg/wk; P<.001). However, participants in the intervention group gained more weight than those in the control group in the second trimester (0.42±0.26 vs 0.33±0.28 kg/wk; P=.04) and third trimester (0.56±0.37 vs 0.43±0.33 kg/wk; P=.02) and overall (13.2±8.20 vs 10.3±7.41 kg; P=.03). Nevertheless, arms did not differ in rates of exceeding gestational weight gain guidelines at any time point. Spontaneous pregnancy loss was less common in the intervention arm than in the control arm (8 [4.9%] vs 19 [11.8%]; odds ratio, 0.39 [0.16-0.92]), but we found no other differences in the secondary or exploratory outcomes. CONCLUSION: Participation in the prepregnancy weight loss intervention had no effect on women's likelihood of exceeding gestational weight gain guidelines. Although the intervention group successfully lost weight before conception, the intervention group was associated with greater weight gain in late pregnancy. To effectively reduce weight throughout pregnancy and improve maternal and child outcomes, prepregnancy weight loss interventions may need to be combined with intensive weight management that continues throughout delivery.

Dietary Patterns with Healthy and Unhealthy Traits Among Overweight/Obese Hispanic Women with or at High Risk for Type 2 Diabetes.

Hispanic women are at high risk for type 2 diabetes (T2D), with obesity and unhealthy eating being important contributing factors. A cross-sectional design was used in this study to identify dietary patterns and their associations with diabetes risk factors. Participants completed a culturally adapted Food Frequency Questionnaire capturing intake over the prior 3 months. Overweight/obese Hispanic women (n = 191) with or at risk for T2D were recruited from a community clinic into a weight loss intervention. Only baseline data was used for this analysis. Dietary patterns and their association with diabetes risk factors (age, body mass index, abdominal obesity, elevated fasting blood glucose [FBG], and hemoglobin A1c). An exploratory factor analysis of dietary data adjusted for energy intake was used to identify eating patterns, and Pearson correlation coefficient (r) to assess the association of the eating patterns with the diabetes risk factors. Six meaningful patterns with healthful and unhealthful traits emerged: (1) sugar and fat-laden, (2) plant foods and fish, (3) soups and starchy dishes, (4) meats and snacks, (5) beans and grains, and (6) eggs and dairy. Scores for the "sugar and fat-laden" and "meats and snacks" patterns were negatively associated with age (r = - 0.230, p = 0.001 and r = - 0.298, p < 0.001, respectively). Scores for "plant foods and fish" were positively associated with FBG (r = 0.152, p = 0.037). Being younger may be an important risk factor for a diet rich in sugar and fat; this highlights the need to assess dietary patterns among younger Hispanic women to identify traits potentially detrimental for their health.

Lessons Learned From a Program to Reduce Diabetes Risk Among Low-Income Hispanic Women in a Community Health Clinic.

Background: The Diabetes Prevention Program (DPP) and Look AHEAD studies demonstrated that modest weight loss and increased physical activity can significantly reduce the incidence of diabetes among overweight individuals with prediabetes. However, these studies involved costly interventions, all of which are beyond the reach of most real-world settings serving high-risk, low-income populations. Our project, De Por Vida, implemented a diabetes risk-reduction intervention for Hispanic women in a Federally Qualified Health Center and assessed the program's efficacy. This report describes the methodology used to develop and implement De Por Vida, the cultural adaptations made, the community-academic partnership formed to carry out this program, and the barriers and challenges encountered through the implementation process. Methods: Our goal was to translate the DPP and Look AHEAD programs into an intervention to prevent diabetes and reduce diabetes complications among high-risk Hispanic women at a federally qualified health center in Hillsboro, Oregon, where more than half of clinic patients are Spanish-speaking, and nearly all live in poverty. This randomized clinical trial targeted overweight Spanish-speaking women at risk for, or diagnosed with, type 2 diabetes. We developed a 12-month behavioral diabetes risk-reduction intervention that was responsive to the cultural practices of the Hispanic population and that could be implemented in low-income clinical settings. Study planning and implementation involved close collaboration among the clinic leadership, a research team from the Kaiser Permanente Center for Health Research, and Arizona State University. Discussion: Creating a fully informed partnership between research and clinical institutions is the first step in successful cooperative research projects. The adoption of a bidirectional, rather than a top-down, approach to communication between researchers and health-care providers, and between clinic management and the clinic frontline staff, gave the research study team crucial information about barriers, constraints, and needs that clinic staff experienced in implementing the program. This allowed clinic management and front-line clinic staff to play an active role in study implementation, identifying problem areas, and collaborating in finding practical solutions. Clinical Trial Registration: www.clinicaltrials.gov, NCT03113916.

Alternative Medicine Methods Used for Weight Loss and Diabetes Control by Overweight and Obese Hispanic Immigrant Women.

INTRODUCTION: Middle-aged Hispanic women have the highest prevalence of overweight and lifetime risk for diabetes of all gender/racial groups. This study examines use of alternative medicine for weight loss and diabetes management among overweight and obese Mexican American women with or at risk for diabetes. METHOD: As part of a diabetes risk-reduction intervention targeting overweight and obese Hispanic women at a federally qualified health center in Hillsboro, Oregon, we administered a survey of different treatment modalities, including alternative medicine, traditional Mexican medicine, and home remedies to 85 Hispanic women. We also asked participants how often they disclosed their use of alternative methods to their providers. RESULTS: Nearly all participants with diabetes (97%) reported using at least one alternative strategy for diabetes control, with home remedies, commercial weight-loss products, and herbal teas being the most endorsed. Most participants with diabetes and half of those without diabetes reported never telling their provider. CONCLUSION: This group of women reported a high prevalence of use of alternative methods for weight control and diabetes management. Yet most participants with diabetes never reported this use to a health care provider. To ensure patient safety, providers treating Hispanic women need to probe for complementary and alternative medicine practices.

Adherence to behavioral recommendations for weight loss and associated psychosocial factors among African American adults.

PURPOSE: To identify patterns of behavioral adherence among 388 African Americans who participated in the Weight Loss Maintenance trial and examine associated psychosocial factors. METHODS: Using repeated measures latent class analysis, we modeled patterns of adherence to recommendations regarding fruit and vegetable, total fat, and saturated fat intake and physical activity at baseline, 6, and 18 months. Latent classes were compared on the SF-36 (mental health composite and vitality subscale), Perceived Stress Scale, and PHQ-8 at each time point. RESULTS: Three distinct latent classes emerged: Nutrition Adherers (n = 96); Physical Activity Adherers (n = 61); and Non-Adherers (n = 231). All groups showed initial improvement in psychosocial measures followed by relapse. Non-Adherers had significantly lower mean mental health and vitality scores and higher depression scores than adherers at 6 and 18 months. CONCLUSION: Psychological well-being should be addressed with African Americans in weight loss treatment to enhance behavior change and improve weight loss outcomes.

High Prevalence of Undiagnosed Hyperglycemia in Low-Income Overweight and Obese Hispanic Women in Oregon.

BACKGROUND: Overweight Hispanic women are at high risk for type 2 diabetes. A clinical diagnosis of hyperglycemia is often necessary to access interventions. We examined the prevalence of undiagnosed hyperglycemia among a group of low-income overweight or obese Hispanic women, who were receiving care at a Federally Qualified Health Center (FQHC). METHODS: Among 196 overweight or obese Hispanic women (mean age 44 ± 10 years, mean weight 86.8 ± 16.5 kg, mean body mass index [BMI] 36.5 ± 6.4 kg/m2) enrolled in a randomized clinical weight-loss trial, we compared A1C and fasting blood glucose (FBG) obtained at baseline with women's existing diabetes and prediabetes diagnoses in the medical record. RESULTS: According to the information in participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis. Among participants without a diagnosis of diabetes or prediabetes during the baseline screening for our study, 63% (55/87) had at least one test in the prediabetes range (baseline A1C and FBG were in prediabetes range for 39 and 55 participants, respectively), and 13% (11/87) had at least one test in the diabetic range (baseline A1C and FBG values in diabetes range for 3 and 11 participants, respectively). DISCUSSION: We found substantial prevalence of undiagnosed hyperglycemia among a sample of overweight and obese Hispanic women. It is possible that limited awareness of diabetes risk may be a barrier to patient compliance with screening recommendations.

Long-Term Outcomes From Repeated Smoking Cessation Assistance in Routine Primary Care.

PURPOSE: To test the association between repeated clinical smoking cessation support and long-term cessation. DESIGN: Retrospective, observational cohort study using structured and free-text data from electronic health records. SETTING: Six diverse health systems in the United States. PARTICIPANTS: Patients aged ≥18 years who were smokers in 2007 and had ≥1 primary care visit in each of the following 4 years (N = 33 691). MEASURES: Primary exposure was a composite categorical variable (comprised of documentation of smoking cessation medication, counseling, or referral) classifying the proportions of visits for which patients received any cessation assistance (<25% (reference), 25%-49%, 50%-74%, and ≥75% of visits). The dependent variable was long-term quit (LTQ; yes/no), defined as no indication of being a current smoker for ≥365 days following a visit where nonsmoker or former smoker was indicated. ANALYSIS: Mixed effects logistic regression analysis adjusted for age, sex, race, and comorbidities, with robust standard error estimation to account for within site correlation. RESULTS: Overall, 20% of the cohort achieved LTQ status. Patients with ≥75% of visits with any assistance had almost 3 times the odds of achieving LTQ status compared to those with <25% visits with assistance (odds ratio = 2.84; 95% confidence interval: 1.50-5.37). Results were similar for specific assistance types. CONCLUSIONS: These findings provide support for the importance of repeated assistance at primary care visits to increase long-term smoking cessation.

Predictors of Long-Term Adherence to Multiple Health Behavior Recommendations for Weight Management.

BACKGROUND: We have demonstrated previously that patterns of behavioral adherence in the first 6 months of behavioral lifestyle interventions were associated with significant weight loss at 18 months. In this article, we extend this work to examine patterns of behavioral adherence over 18 months and to explore baseline demographic and psychosocial predictors. METHOD: Latent class analysis was applied separately to the Weight Loss Maintenance and PREMIER trials data to examine patterns of adherence to the following recommendations: (1) consuming ≥9 servings of fruits and vegetables per day, (2) ≤25% of energy from total fat, (3) ≤7% energy from saturated fat, and (4) ≥180 minutes of moderate-to-vigorous physical activity per week. Multinomial logistic regression was used to test demographic and psychosocial predictors of latent class membership. RESULTS: Four distinct subgroups with common patterns of behavioral adherence were identified in each trial including, Behavioral Maintainers, who maintained adherence to all behavioral recommendations for 1 year, Nonresponders, who did not adhere to the recommendations at any time point, and latent classes that reflected patterns of adherence to one or two behaviors or behavioral relapse. A significantly higher proportion of Behavioral Maintainers sustained ≥5% weight loss for 1 year compared with Nonresponders. Participants with higher vitality scores at baseline were more likely to belong to a latent class with long-term adherence to one or more recommendations than the Nonresponders class. CONCLUSIONS: Regular assessment of health behaviors and psychosocial measures such as vitality may help identify nonresponders and inform treatment tailoring to improve long-term behavioral and weight outcomes.

Adult obesity management in primary care, 2008-2013.

In the U.S., the occurrence of weight counseling in primary care for patients with obesity decreased by 10% between 1995-1996 and 2007-2008. There have been several national recommendations and policies to improve obesity management since 2008. The purpose of this study was to examine the rates of body mass index (BMI) screening, obesity diagnosis, and weight management counseling in the U.S. from 2008 to 2013. The National Ambulatory Medical Care Survey visit-level data for adults 18 and over with a primary care visit during survey years 2008-2009, 2010-2011, and 2012-2013 was included in the analyses using SAS v9.3. Study outcomes included percent of visits with: BMI screening; obesity diagnosis; and weight counseling. We compared survey years on these outcomes using 2008-2009 as the reference as well as examined patient and practice-level predictors. Analyses were conducted from 2015 to early 2017. Of the total 55,608 adult primary care visits sampled, 14,143 visits (25%) were with patients with obesity. BMI screening significantly increased between 2008-2009 and 2012-2013 from 54% to 73% (OR=1.75, 95% CI 1.28-2.41); however, percent of visits with an obesity diagnosis remained low at <30%. Weight management counseling during visits significantly declined from 33% to 21% between 2008-2009 and 2012-2013 (OR=0.62, 95% CI 0.41-0.92). Despite emerging recommendations and policies, from 2008 to 2013, obesity management in primary care remained suboptimal. Identifying practical strategies to enforce policies and implement evidence-based behavioral treatment in primary care should be a high priority in healthcare reform.

ACC/AHA Special Report: Clinical Practice Guideline Implementation Strategies: A Summary of Systematic Reviews by the NHLBI Implementation Science Work Group: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

BACKGROUND: In 2008, the National Heart, Lung, and Blood Institute convened an Implementation Science Work Group to assess evidence-based strategies for effectively implementing clinical practice guidelines. This was part of a larger effort to update existing clinical practice guidelines on cholesterol, blood pressure, and overweight/obesity. OBJECTIVES: Review evidence from the published implementation science literature and identify effective or promising strategies to enhance the adoption and implementation of clinical practice guidelines. METHODS: This systematic review was conducted on 4 critical questions, each focusing on the adoption and effectiveness of 4 intervention strategies: (1) reminders, (2) educational outreach visits, (3) audit and feedback, and (4) provider incentives. A scoping review of the Rx for Change database of systematic reviews was used to identify promising guideline implementation interventions aimed at providers. Inclusion and exclusion criteria were developed a priori for each question, and the published literature was initially searched up to 2012, and then updated with a supplemental search to 2015. Two independent reviewers screened the returned citations to identify relevant reviews and rated the quality of each included review. RESULTS: Audit and feedback and educational outreach visits were generally effective in improving both process of care (15 of 21 reviews and 12 of 13 reviews, respectively) and clinical outcomes (7 of 12 reviews and 3 of 5 reviews, respectively). Provider incentives showed mixed effectiveness for improving both process of care (3 of 4 reviews) and clinical outcomes (3 reviews equally distributed between generally effective, mixed, and generally ineffective). Reminders showed mixed effectiveness for improving process of care outcomes (27 reviews with 11 mixed and 3 generally ineffective results) and were generally ineffective for clinical outcomes (18 reviews with 6 mixed and 9 generally ineffective results). Educational outreach visits (2 of 2 reviews), reminders (3 of 4 reviews), and provider incentives (1 of 1 review) were generally effective for cost reduction. Educational outreach visits (1 of 1 review) and provider incentives (1 of 1 review) were also generally effective for cost-effectiveness outcomes. Barriers to clinician adoption or adherence to guidelines included time constraints (8 reviews/overviews); limited staffing resources (2 overviews); timing (5 reviews/overviews); clinician skepticism (5 reviews/overviews); clinician knowledge of guidelines (4 reviews/overviews); and higher age of the clinician (1 overview). Facilitating factors included guideline characteristics such as format, resources, and end-user involvement (6 reviews/overviews); involving stakeholders (5 reviews/overviews); leadership support (5 reviews/overviews); scope of implementation (5 reviews/overviews); organizational culture such as multidisciplinary teams and low-baseline adherence (9 reviews/overviews); and electronic guidelines systems (3 reviews). CONCLUSION: The strategies of audit and feedback and educational outreach visits were generally effective in improving both process of care and clinical outcomes. Reminders and provider incentives showed mixed effectiveness, or were generally ineffective. No general conclusion could be reached about cost effectiveness, because of limitations in the evidence. Important gaps exist in the evidence on effectiveness of implementation interventions, especially regarding clinical outcomes, cost effectiveness and contextual issues affecting successful implementation.

ACC/AHA Special Report: Clinical Practice Guideline Implementation Strategies: A Summary of Systematic Reviews by the NHLBI Implementation Science Work Group: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

BACKGROUND: In 2008, the National Heart, Lung, and Blood Institute convened an Implementation Science Work Group to assess evidence-based strategies for effectively implementing clinical practice guidelines. This was part of a larger effort to update existing clinical practice guidelines on cholesterol, blood pressure, and overweight/obesity. OBJECTIVES: Review evidence from the published implementation science literature and identify effective or promising strategies to enhance the adoption and implementation of clinical practice guidelines. METHODS: This systematic review was conducted on 4 critical questions, each focusing on the adoption and effectiveness of 4 intervention strategies: (1) reminders, (2) educational outreach visits, (3) audit and feedback, and (4) provider incentives. A scoping review of the Rx for Change database of systematic reviews was used to identify promising guideline implementation interventions aimed at providers. Inclusion and exclusion criteria were developed a priori for each question, and the published literature was initially searched up to 2012, and then updated with a supplemental search to 2015. Two independent reviewers screened the returned citations to identify relevant reviews and rated the quality of each included review. RESULTS: Audit and feedback and educational outreach visits were generally effective in improving both process of care (15 of 21 reviews and 12 of 13 reviews, respectively) and clinical outcomes (7 of 12 reviews and 3 of 5 reviews, respectively). Provider incentives showed mixed effectiveness for improving both process of care (3 of 4 reviews) and clinical outcomes (3 reviews equally distributed between generally effective, mixed, and generally ineffective). Reminders showed mixed effectiveness for improving process of care outcomes (27 reviews with 11 mixed and 3 generally ineffective results) and were generally ineffective for clinical outcomes (18 reviews with 6 mixed and 9 generally ineffective results). Educational outreach visits (2 of 2 reviews), reminders (3 of 4 reviews), and provider incentives (1 of 1 review) were generally effective for cost reduction. Educational outreach visits (1 of 1 review) and provider incentives (1 of 1 review) were also generally effective for cost-effectiveness outcomes. Barriers to clinician adoption or adherence to guidelines included time constraints (8 reviews/overviews); limited staffing resources (2 overviews); timing (5 reviews/overviews); clinician skepticism (5 reviews/overviews); clinician knowledge of guidelines (4 reviews/overviews); and higher age of the clinician (1 overview). Facilitating factors included guideline characteristics such as format, resources, and end-user involvement (6 reviews/overviews); involving stakeholders (5 reviews/overviews); leadership support (5 reviews/overviews); scope of implementation (5 reviews/overviews); organizational culture such as multidisciplinary teams and low-baseline adherence (9 reviews/overviews); and electronic guidelines systems (3 reviews). CONCLUSION: The strategies of audit and feedback and educational outreach visits were generally effective in improving both process of care and clinical outcomes. Reminders and provider incentives showed mixed effectiveness, or were generally ineffective. No general conclusion could be reached about cost effectiveness, because of limitations in the evidence. Important gaps exist in the evidence on effectiveness of implementation interventions, especially regarding clinical outcomes, cost effectiveness and contextual issues affecting successful implementation.

One-year postpartum outcomes following a weight management intervention in pregnant women with obesity.

OBJECTIVE: This analysis was focused on 1-year maternal and infant follow-up of a randomized trial that tested a weight management intervention conducted during pregnancy. METHODS: One hundred fourteen women with obesity (mean BMI 36.7 kg/m(2) ) were randomly assigned at a mean of 15 weeks gestation to a weight management intervention or usual care control condition. The intervention ended at delivery and resulted in less gestational weight gain and a lower proportion of large-for-gestational-age newborns among intervention compared with control participants. The primary outcome at 12 months postpartum was maternal weight. Secondary outcomes included infant weight-for-age and weight-for-length z-scores. RESULTS: At 1 year, mothers in the intervention group weighed 96.3 ± 18.6 kg and those in the control group 99.7 ± 19.2 kg. There was no significant difference between groups in change in weight from randomization to 1 year postpartum (b = -0.47, 95% CI: -4.03 to 3.08). There was a significant main effect of group for infant weight-for-age z-scores (b = -0.40, 95% CI: -0.75 to -0.05) but not infant weight-for-length z-scores (b = -0.20, 95% CI: -0.59 to 0.20). CONCLUSIONS: A gestational weight management intervention did not influence maternal weight or infant weight-for-length at 1 year postpartum. Future studies may be warranted to determine whether extending prenatal interventions into the postpartum period would be beneficial for maternal and infant outcomes.

Prepare, a randomized trial to promote and evaluate weight loss among overweight and obese women planning pregnancy: Study design and rationale.

BACKGROUND: Women who are overweight or have obesity at pregnancy onset, and those who gain excessive weight during pregnancy, are at increased risk of pregnancy-related complications and large for gestational age infants. OBJECTIVE: This report describes methodology for the Prepare study, a randomized, controlled clinical trial testing a preconception and pregnancy weight management program for women who are overweight or have obesity (BMI≥27kg/m(2)). OUTCOMES: This trial examines multiple pregnancy and neonatal outcomes, with the primary outcome being gestational weight gain (GWG). Secondary outcomes include change in weight before conception, offspring birth weight adjusted for gestational age, offspring weight for length, and pregnancy diet quality and physical activity level. METHODS: Nonpregnant women who anticipate becoming pregnant in the next 2years are randomly assigned to an intervention program or a usual care control condition. Intervention participants receive weight management counseling by telephone before and during pregnancy, with weekly contacts during the first 6months and monthly contacts for the next 18months. Intervention participants also have unlimited access to a study website that provides self-management tools. All participants who become pregnant are contacted at 20weeks' gestation to assess physical activity levels and dietary habits. All other outcome data are obtained from medical records. Intervention satisfaction is assessed via questionnaire. SUMMARY: This clinical trial tests the efficacy of an intervention program designed to help overweight and obese women achieve healthy lifestyle changes that will result in a healthy weight prior to pregnancy and appropriate weight gain during pregnancy.

The impact of continued intervention on weight: Five-year results from the weight loss maintenance trial.

OBJECTIVE: In the Weight Loss Maintenance (WLM) Trial, a personal contact (PC) intervention sustained greater weight loss relative to a self-directed (SD) group over 30 months. This study investigated the effects of continued intervention over an additional 30 months and overall weight change across the entire WLM Trial. METHODS: WLM had 3 phases. Phase 1 was a 6-month weight loss program. In Phase 2, those who lost ≥4 kg were randomized to a 30-month maintenance trial. In Phase 3, PC participants (n = 196, three sites) were re-randomized to no further intervention (PC-Control) or continued intervention (PC-Active) for 30 more months; 218 SD participants were also followed. RESULTS: During Phase 3, weight increased 1.0 kg in PC-Active and 0.5 kg in PC-Control (mean difference 0.6 kg; 95% CI:-1.4 to 2.7; P = 0.54). Mean weight change over the entire study was -3.2 kg in those originally assigned to PC (PC-Combined) and -1.6 kg in SD (mean difference -1.6 kg; 95% CI:-3.0 to -0.1; P = 0.04). CONCLUSIONS: After 30 months of the PC maintenance intervention, continuation for another 30 months provided no additional benefit. However, across the entire study, weight loss was slightly greater in those originally assigned to PC.