Susan D. Brown

A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes’ Effects on Moms (GEM) study

BackgroundWomen with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes’ Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level.Methods/DesignThe GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks).DiscussionThere is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population. Given the use of a telephonic case management model, our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM.Trial registrationClinical Trials.gov number, NCT01344278.

The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes’ Effects on Moms (GEM) Cluster Randomized Controlled Trial

OBJECTIVE To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)–derived lifestyle intervention. RESEARCH DESIGN AND METHODS This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m2 or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m2; and pregravid to postpartum weight change. RESULTS On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference −0.64 kg [95% CI −1.13, −0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). CONCLUSIONS A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity.

Risk of large-for-gestational-age newborns in women with gestational diabetes by race and ethnicity and body mass index categories.

OBJECTIVE: To compare the prevalence of large-for-gestational-age (LGA) newborns across categories of body mass index (BMI) in five racial and ethnic groups. METHODS: This cohort study examined 7,468 women with gestational diabetes mellitus (GDM) who delivered a live newborn between 1995 and 2006 at Kaiser Permanente Northern California. The racial and ethnic groups were non-Hispanic white, African American, Hispanic, Asian, and Filipina. The BMI was classified using the World Health Organization International guidelines (normal, 18.50–24.99; overweight, 25.00–29.99; obese, 30.00–34.99; obese class II, 35.00 or higher). Having an LGA newborn was defined as birth weight more than 90th percentile for the study populations race or ethnicity and gestational age--specific birth weight distribution. Logistic regression was used to estimate odds of having an LGA newborn by BMI and race and ethnicity. RESULTS: Overall prevalence of LGA newborns was highest in African American women (25.1%), lowest in Asians (13.9%), and intermediate among Hispanic (17.3%), white (16.4%), and Filipina women (15.3%). The highest increased risk of LGA newborns was observed among women with class II obesity in most racial and ethnic groups, and African American and Asian women with class II obesity had a four-fold increased risk of LGA newborns compared with women of normal weight in the same racial and ethnic group. CONCLUSIONS: African American women with GDM have a greater risk of LGA newborns at a lower BMI than other racial and ethnic groups. Clinicians should be aware that among women with GDM, there may be significant racial and ethnic differences in the risk of LGA newborns by BMI threshold. LEVEL OF EVIDENCE: II

The Stanford Leisure-Time Activity Categorical Item (L-Cat): A single categorical item sensitive to physical activity changes in overweight/obese women

Background:Physical activity is essential for chronic disease prevention, yet <40% of overweight/obese adults meet the national activity recommendations. For time-efficient counseling, clinicians need a brief, easy-to-use tool that reliably and validly assesses a full range of activity levels, and, most importantly, is sensitive to clinically meaningful changes in activity. The Stanford Leisure-Time Activity Categorical Item (L-Cat) is a single item comprising six descriptive categories ranging from inactive to very active. This novel methodological approach assesses national activity recommendations as well as multiple clinically relevant categories below and above the recommendations, and incorporates critical methodological principles that enhance psychometrics (reliability, validity and sensitivity to change).Methods:We evaluated the L-Cat’s psychometrics among 267 overweight/obese women who were asked to meet the national activity recommendations in a randomized behavioral weight-loss trial.Results:The L-Cat had excellent test–retest reliability (κ=0.64, P<0.001) and adequate concurrent criterion validity; each L-Cat category at 6 months was associated with 1059 more daily pedometer steps (95% CI 712–1407, β=0.38, P<0.001) and 1.9% greater initial weight loss at 6 months (95% CI −2.4 to −1.3, β=−0.38, P<0.001). Of interest, L-Cat categories differentiated from each other in a dose-response gradient for steps and weight loss (Ps<0.05) with excellent face validity. The L-Cat was sensitive to change in response to the trial’s activity component. Women increased one L-Cat category at 6 months (M=1.0±1.4, P<0.001); 55.8% met the recommendations at 6 months whereas 20.6% did at baseline (P<0.001). Even among women not meeting the recommendations at both baseline and 6 months (n=106), women who moved ⩾1 L-Cat categories at 6 months lost more weight than those who did not (M=−4.6%, 95% CI −6.7 to −2.5, P<0.001).Conclusions:Given strong psychometrics, the L-Cat has timely potential for clinical use such as tracking activity changes via electronic medical records, especially among overweight/obese populations who are unable or unlikely to reach national recommendations.

Post-partum weight loss and glucose metabolism in women with gestational diabetes: the DEBI Study

Women with gestational diabetes are at high risk for developing diabetes; post‐partum weight loss may reduce the risk of diabetes. We evaluated the association of post‐partum weight change with changes in glucose, insulin and homeostasis model assessment of insulin resistance in a subsample (n = 72) of participants from Diet Exercise and Breastfeeding Intervention (DEBI), a randomized pilot trial of lifestyle intervention for women with gestational diabetes.

Health-plan and employer-based wellness programs to reduce diabetes risk: The Kaiser Permanente Northern California NEXT-D Study.

Primary prevention of diabetes is increasingly recognized by both health plans and employers as an important strategy to improve the health of insured populations. As a part of the Natural Experiments in Translation for Diabetes (NEXT-D) network, the Kaiser Permanente Northern California (KPNC) Division of Research is assessing the effectiveness of 2 health plan-initiated programs to prevent the onset of diabetes in patients at high risk. The first study evaluates a telephonic health-coaching program that provides counseling on healthful eating, active living, and weight loss to KPNC members. The second evaluation examines a postpartum glucose screening and educational diabetes prevention program for women with gestational diabetes mellitus that KPNC implemented in 2006. Identifying effective approaches to preventing diabetes will be of value to health care systems, policy makers, and public health officials seeking to understand the roles systems and employers can play in preventing chronic illness.

Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011.

Introduction Health coaching can improve lifestyle behaviors known to prevent or manage chronic conditions such as diabetes. However, little is known about the patient experience with telephonic coaching programs in real-world care settings. We examined patient satisfaction, patient’s perceived success in achieving program goals, and the patient-level correlates of these outcomes in a voluntary telephonic coaching program at a large integrated health care delivery system in northern California. Methods Kaiser Permanente Northern California patients who participated in a telephonic coaching program in 2011 were sent a cross-sectional survey about their satisfaction with health coaching and perceived success with program goals. We examined associations with patient characteristics. Results The survey response rate was 34%; analyses were based on the 32% who completed the survey. Of those who had completed 2 or more sessions (n = 232 [52%]), most reported being satisfied (70%) or neutral (20%) with the program, and 71% would recommend health coaching. Healthy weight, healthful eating, and physical activity were the most common topics discussed (88%). Adjusting for demographic characteristics, 73% of those who had 2 or more sessions reported that health coaching helped achieve their weight-related goal. Outcomes were positively correlated with patient activation but not consistently correlated with patient demographic characteristics. Conclusion Levels of satisfaction and perceived success with telephonic health coaching provided by a health plan were high and positively correlated with the number of sessions completed and patient activation. Voluntary telephonic health coaching programs should promote retention and assess patients’ activation levels.

Outreach to diversify clinical trial participation: A randomized recruitment study.

Background/Aims Racial and ethnic minorities remain underrepresented in clinical research, yet few recruitment strategies have been rigorously evaluated. Methods We experimentally tested whether targeted recruitment letters acknowledging diabetes health disparities and health risks specific to recipients’ racial/ethnic group improved two metrics of trial participation: willingness to be screened and enrollment. This experiment was efficiently nested within a randomized clinical trial examining a preventive lifestyle intervention among women at high risk for diabetes. Pregnant women with gestational diabetes or impaired glucose tolerance (N = 445) were randomized to receive a targeted recruitment letter with health risk information specific to their racial/ethnic group (n = 216), or a standard letter with risk information for the general population (n = 229). All letters were bilingual in English and Spanish. Results The targeted as compared to the standard letter did not improve screening or enrollment rates overall or within separate racial/ethnic groups. Among Latina women who preferred Spanish, the targeted letter showed trends for improved screening (66.7% vs 33.3%, p = .06) and enrollment rates (38.9% vs 13.3%, p = .13). In contrast, among Latina women who preferred English, the targeted letter significantly lowered screening (29.6% vs 57.1%, p = .04) and showed trends for lowered enrollment rates (25.9% vs 50.0%, p = .07). Conclusion Results from this randomized study appear to suggest that recruitment letters with diabetes health risk information targeted to recipients’ race/ethnicity may improve one metric of clinical trial participation among Latina women who prefer Spanish, but not English. Larger experimental studies, incorporating input from diverse participant stakeholders, are needed to develop evidence-based minority recruitment strategies.

Telephone-Based Coaching A Comparison of Tobacco Cessation Programs in an Integrated Health Care System

Purpose. Many Americans continue to smoke, increasing their risk of disease and premature death. Both telephone-based counseling and in-person tobacco cessation classes may improve access for smokers seeking convenient support to quit. Little research has assessed whether such programs are effective in real-world clinical populations. Design. Retrospective cohort study comparing wellness coaching participants with two groups of controls. Setting. Kaiser Permanente Northern California, a large integrated health care delivery system. Subjects. Two hundred forty-one patients who participated in telephonic tobacco cessation coaching from January 1, 2011, to March 31, 2012, and two control groups: propensity-score–matched controls, and controls who participated in a tobacco cessation class during the same period. Wellness coaching participants received an average of two motivational interviewing–based coaching sessions that engaged the patient, evoked their reason to consider quitting, and helped them establish a quit plan. Measures. Self-reported quitting of tobacco and fills of tobacco cessation medications within 12 months of follow-up. Analysis. Logistic regressions adjusting for age, gender, race/ethnicity, and primary language. Results. After adjusting for confounders, tobacco quit rates were higher among coaching participants vs. matched controls (31% vs. 23%, p < .001) and comparable to those of class attendees (31% vs. 29%, p = .28). Coaching participants and class attendees filled tobacco-cessation prescriptions at a higher rate (47% for both) than matched controls (6%, p < .001). Conclusion. Telephonic wellness coaching was as effective as in-person classes and was associated with higher rates of quitting compared to no treatment. The telephonic modality may increase convenience and scalability for health care systems looking to reduce tobacco use and improve health.

Wellness Coaching for People With Prediabetes: A Randomized Encouragement Trial to Evaluate Outreach Methods at Kaiser Permanente, Northern California, 2013

Introduction Health coaching can improve lifestyle behaviors known to prevent or manage chronic conditions. Little is known about effective ways to encourage health and wellness coaching among people who might benefit. The purpose of this randomized encouragement trial was to assess the relative success of 3 outreach methods (secured email message, telephone message, and mailed letter) on the use of wellness coaching by people with prediabetes. Methods A total of 14,584 Kaiser Permanente Northern California (KPNC) patients with diagnosed prediabetes (fasting plasma glucose, 110–125mg/dL) were randomly assigned to be contacted via 1 of 4 intervention arms from January through May 2013. The uptake rate (making an appointment at the Wellness Coaching Center [WCC]) was assessed, and the association between uptake rate and patient characteristics was examined via multivariable logistic regression. Results The overall uptake rate across intervention arms was 1.9%. Secured email message had the highest uptake rate (3.0%), followed by letters and telephone messages (P < .05 for all pairwise comparisons). No participants in the usual-care arm (ie, no outreach) made an appointment with the WCC. For each year of increased age, the estimated odds of the uptake increased by 1.02 (odds ratio [OR] = 1.02; 95% CI, 1.01–1.04). Women were nearly twice as likely to make an appointment at the WCC as men (OR = 1.87; 95% CI, 1.40–2.51). Conclusion Our results suggest that the WCC can recruit and encourage KPNC members with prediabetes to participate in the WCC. Future research should focus on increasing participation rates in health coaching among patients who may benefit.