HELP PD was a clinical trial of 301 adults with prediabetes. Participants were randomized to enhanced usual care (EUC) or to a lifestyle weight loss (LWL) intervention led by community health workers ...that consisted of a 6-month intensive phase (phase 1) and 18 months of maintenance (phase 2). At 24 months, participants were asked to enroll in phase 3 to assess whether continued group maintenance (GM) sessions would maintain improvements realized in phases 1 and 2 compared with self-directed maintenance (SM) or EUC.
In phase 3, LWL participants were randomly assigned to GM or SM. EUC participants remained in the EUC arm and, along with participants in SM, received monthly newsletters. All participants received semiannual dietitian sessions. Anthropometrics and biomarkers were assessed every 6 months. Mixed-effects models were used to assess changes in outcomes over time.
Eighty-two of the 151 intervention participants (54%) agreed to participate in phase 3; 41 were randomized to GM and 41 to SM. Of the 150 EUC participants, 107 (71%) continued. Ninety percent of clinic visits were completed. Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly (
< 0.001) in the SM group.
Participants in the GM arm maintained weight loss achieved in phases 1 and 2, while those in the SM arm regained weight. Because group session attendance by the participants in the GM arm was low, it is unclear what intervention components led to successful weight maintenance.
Although technology-assisted diabetes prevention programs (DPPs) have been shown to improve glycemic control and weight loss, information are limited regarding relevant costs and their ...cost-effectiveness. To describe a retrospective within-trial cost and cost-effectiveness analysis (CEA) to compare a digital-based DPP (d-DPP) with small group education (SGE), over a 1-year study period. The costs were summarized into direct medical costs, direct nonmedical costs (i.e., times that participants spent engaging with the interventions), and indirect costs (i.e., lost work productivity costs). The CEA was measured by the incremental cost-effectiveness ratio (ICER). Sensitivity analysis was performed using nonparametric bootstrap analysis. Over 1 year, the direct medical costs, direct nonmedical costs, and indirect costs per participant were $4,556, $1,595, and $6,942 in the d-DPP group versus $4,177, $1,350, and $9,204 in the SGE group. The CEA results showed cost savings from d-DPP relative to SGE based on a societal perspective. Using a private payer perspective for d-DPP, ICERs were $4,739 and $114 to obtain an additional unit reduction in HbA1c (%) and weight (kg), and were $19,955 for an additional unit gain of quality-adjusted life years (QALYs) compared to SGE, respectively. From a societal perspective, bootstrapping results indicated that d-DPP has a 39% and a 69% probability, at a willingness-to-pay of $50,000/QALY and $100,000/QALY, respectively, of being cost-effective. The d-DPP was cost-effective and offers the prospect of high scalability and sustainability due to its program features and delivery modes, which can be easily translated to other settings.
About 48 % of US women gain more weight during pregnancy than recommended by the Institute of Medicine (IOM). Excessive gestational weight gain is a major risk factor for obesity in both women and ...offspring over their lifetimes, and should be avoided. This study was designed to test the feasibility and initial efficacy of a prenatal behavioral intervention in a sample of low-income, predominantly Latina women. The intervention was delivered in groups of 8–10 women in a community recreation center, and structured to reduce the proportion of women who gained weight in excess of IOM guidelines. Recruitment targets were met in 3 months: 135 pregnant women (>10 and <28 weeks) were randomly assigned to receive a 12-week intervention (n = 68) or usual care (n = 67). Retention rate was 81 %. On average, women attended 4 of 12 group sessions, and each session had 4 of the 8–10 assigned participants in attendance. Initial efficacy analyses were based on 87 women. Compared to usual care, fewer normal-weight women in the intervention exceeded IOM recommendations (47.1 % usual care vs. 6.7 % intervention; absolute difference 40.4 %;
p
= .036). Recommendations for recruitment, retention, and delivery are discussed. A community-based cognitive-behavioral lifestyle intervention during pregnancy was feasible in a hard-to-reach, high-risk population of low-income Latina women, and showed efficacy in preventing excessive gestational weight gain. Due to frequently changing work schedules, strategies are needed to either increase attendance at group sessions (e.g., within a group prenatal care format) or to build core skills necessary for behavior change through other modalities.
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DOBA, EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, IZUM, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UILJ, UKNU, UL, UM, UPUK, VKSCE, VSZLJ, ZAGLJ
OBJECTIVES: To determine whether participation in usual moderate‐intensity or more‐vigorous physical activity (MVPA) is associated with physical function performance and to identify sociodemographic, ...psychosocial, and disease‐related covariates that may also compromise physical function performance.
DESIGN: Cross‐sectional analysis of baseline variables of a randomized controlled intervention trial.
SETTING: Four academic research centers.
PARTICIPANTS: Four hundred twenty‐four older adults aged 70 to 89 at risk for mobility disability (scoring <10 on the Short Physical Performance Battery (SPPB)) and able to complete the 400‐m walk test within 15 minutes.
MEASUREMENTS: Minutes of MVPA (dichotomized according to above or below 150 min/wk of MVPA) assessed according to the Community Healthy Activities Model Program for Seniors questionnaire, SPPB score, 400‐m walk test, sex, body mass index (BMI), depressive symptoms, age, and number of medications.
RESULTS: The SPPB summary score was associated with minutes of MVPA (ρ=0.16, P=.001). In multiple regression analyses, age, minutes of MVPA, number of medications, and depressive symptoms were associated with performance on the composite SPPB (P<.05). There was an association between 400‐m walk time and minutes of MVPA (ρ=−0.18; P<.001). In multiple regression analyses, age, sex, minutes of MVPA, BMI, and number of medications were associated with performance on the 400‐m walk test (P<.05).
CONCLUSION: Minutes of MVPA, sex, BMI, depressive symptoms, age, and number of medications are associated with physical function performance and should all be taken into consideration in the prevention of mobility disability.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Although numerous studies have translated the Diabetes Prevention Program lifestyle intervention into various settings, no study to date has reported a formal cost analysis.
To describe costs ...associated with the Healthy Living Partnerships to Prevent Diabetes (HELP PD) trial.
HELP PD was a 24-month RCT testing the impact of a lifestyle weight-loss intervention administered through a diabetes education program and delivered by community health workers (CHWs) on blood glucose and body weight among prediabetics.
In all, 301 participants with prediabetes were randomized in Forsyth County NC. Data reported in these analyses were collected in 2007-2011 and analyzed in 2011-2012.
The lifestyle weight-loss group had a 7% weight loss goal achieved and maintained by caloric restriction and increased physical activity. The usual care group received two visits with a registered dietitian and monthly newsletters.
Measures are direct medical costs, direct nonmedical costs, and indirect costs over the 2-year study period. Research costs are excluded.
The direct medical cost (in 2010 dollars) to identify one participant was $16.85. Direct medical costs per capita for participants in the usual care group were $142 and $850 for lifestyle weight-loss participants. Per capita direct costs of care outside the study were $7454 for the usual care group and $5177 for the lifestyle weight-loss group. Per capita direct nonmedical costs were $12,881 for the usual care group and $13,836 for the lifestyle weight-loss group. The lifestyle weight-loss group in HELP PD cost $850 in direct medical costs for 2 years, compared to $2631 in direct medical costs for the first 2 years of DPP.
A community-based translation of the DPP can be delivered effectively and with reduced costs.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
OBJECTIVES: To determine the prevalence of self‐reported napping and its association with subjective nighttime sleep duration and quality, as measured according to sleep‐onset latency and sleep ...efficiency.
DESIGN: Cross‐sectional study.
SETTING: Lifestyle Interventions and Independence for Elders Pilot Study.
PARTICIPANTS: Community‐dwelling older adults (N=414) aged 70 to 89.
MEASUREMENTS: Self‐report questionnaire on napping and sleep derived from the Pittsburgh Sleep Quality Index (PSQI) scale.
RESULTS: Fifty‐four percent of participants reported napping, with mean nap duration of 55.0±41.2 minutes. Nappers were more likely to be male (37.3% vs 23.8%, P=.003) and African American (20.4% vs 14.4%, P=.06) and to have diabetes mellitus (28% vs 14.3%, P=.007) than non‐nappers. Nappers and non‐nappers had similar nighttime sleep duration and quality, but nappers spent approximately 10% of their 24‐hour sleep occupied in napping. In a multivariate model, the odds of napping were higher for subjects with diabetes mellitus (odds ratio (OR)=1.9, 95% confidence interval (CI)=1.2–3.0) and men (OR=1.9, 95% CI=1.2–3.0). In nappers, diabetes mellitus (β=12.3 minutes, P=.005), male sex (β=9.0 minutes, P=.04), higher body mass index (β=0.8 minutes, P=.02), and lower Mini‐Mental State Examination score (β=2.2 minutes, P=.03) were independently associated with longer nap duration.
CONCLUSION: Napping was a common practice in community‐dwelling older adults and did not detract from nighttime sleep duration or quality. Given its high prevalence and association with diabetes mellitus, napping behavior should be assessed as part of sleep behavior in future research and in clinical practice.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Diabetes prevention remains a top public health priority; digital approaches are potential solutions to existing scalability and accessibility challenges. There remains a gap in our understanding of ...the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings.
To describe the methods and design of a type 1 hybrid effectiveness-implementation trial of a digital diabetes prevention program (DPP) using the iPARIHS and RE-AIM frameworks.
The trial will contrast the effects of two DPP interventions: (1) small group, in-person class, and (2) a digital DPP consisting of small group support, personalized health coaching, digital tracking tools, and weekly behavior change curriculum. Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the CDC National DPP. Adults at risk for diabetes (BMI ≥25 and 5.7% ≤ HbA1c ≤ 6.4) will be randomly assigned to either the intervention group (n = 241) or the small group (n = 241). Assessment of primary (HbA1c) and secondary (weight loss, costs, cardiovascular risk factors) outcomes will occur at baseline, 4, and 12 months. Additionally, the trial will explore the potential for future adoption, implementation, and sustainability of the digitally-based intervention within a regional healthcare system based on key informant interviews and assessments of organizational administrators and primary care physicians.
This trial of a digital DPP will allow the research team to determine the relationships between reach, effectiveness, implementation, and costs.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Background Tai Chi Chuan (TCC) is an integrative medicine mind-body practice with a physical activity component that has positive effects on aerobic capacity, muscular strength, and quality ...of life among cancer survivors, similar to the effects elicited by other modes of moderate-intensity exercise. Inflammatory cytokines and insulin and insulin-related signaling molecules may contribute to weight gain and affect cancer recurrence rates and survival; exercise can curb cancer- and treatment-related weight gain, increase survival, and reduce levels of insulin and inflammatory cytokines. Despite knowing the beneficial effects of conventional exercise interventions on these mediators, little is known about the physiologic effects of TCC on these pathways in breast cancer survivors. Methods We assessed the effects of a 12-week, moderately intense, TCC intervention (n = 9) compared with a non–physical activity control (n = 10) consisting of psychosocial support therapy (PST), on levels of insulin, insulin-like growth factor (IGF)-1, insulin growth factor-like binding protein (IGFBP)-1, IGFBP-3, and cytokines interleukin (IL)-6, IL-2, and interferon (IFN)-γ in breast cancer survivors. Results Levels of insulin are significantly different in TCC and PST groups; levels remained stable in the TCC group but increased in the PST control group ( P = .099). Bivariate analysis revealed novel and significant correlations (all r > 0.45, all P ≤ .05) of both decreased fat mass and increased fat-free mass with increased IL-6 and decreased IL-2 levels. Conclusions This pilot study shows that TCC may be associated with maintenance of insulin levels and changes in cytokine levels that may be important for maintenance of lean body mass in breast cancer survivors.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
To examine changes in cardiovascular disease (CVD) risk outcomes of overweight/obese adults with prediabetes.
Using data from a randomized control trial of digital diabetes prevention program (d‐DPP) ...with 599 participants. We applied the atherosclerotic CVD (ASCVD) risk calculator to predict 10-year CVD risk for d‐DPP and small education (comparison) groups. Between-group risk changes at 4 and 12 months were compared using a repeated measures linear mixed-effect model. We examined within-group differences in proportion of participants over time for specific CVD risk factors using generalized estimating equations.
We found no differences between baseline 10-year ASCVD risk. Relative to the comparison group, the d‐DPP group experienced greater reductions in predicted 10-year ASCVD risk at each follow-up visit and a significant group difference at 4 months (−0.96%; 95% confidence interval: −1.58%, −0.34%) (but not at 12 months). Additionally, we observed that the d‐DPP group experienced a decreased proportion of individuals with hyperlipidemia (18% and 16% from baseline to 4 and 12 months), high-risk total cholesterol (8% from baseline to 12 months), and being insufficiently active (26% and 22% from baseline to 4 and 12 months at follow-up time points.
Our findings suggest that a digitally adapted DPP may promote the prevention of cardiometabolic disease among overweight/obese individuals with prediabetes. However, given the lack of maintenance of effect on ASCVD risk at 12 months, there may also be a need for additional interventions to sustain the effect detected at 4 months.
•The 10-year CVD risk was reduced by 0.96% with a d‐DPP at 4 months.•The proportion of people with cardiometabolic risk factors was reduced in a d‐DPP.•Targeting peoples with prediabetes at intermediate or high ASCVD risk at baseline.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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