Dataset Information

Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov. OBJECTIVE:This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment. METHODS:This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery. RESULTS:This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024. CONCLUSIONS:This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country. TRIAL REGISTRATION:ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/15499.

SUBMITTER: Ritchie ND

PROVIDER: S-EPMC7296404 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial.

Ritchie Natalie D ND Holtrop Jodi Summers JS Gritz R Mark RM Sauder Katherine Ann KA Durfee Michael Josh MJ Dickinson L Miriam LM Kaufmann Peter G PG Kaufmann Peter G PG

JMIR research protocols 20200601 6

<h4>Background</h4>Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve ND ...[more]

PMID: 32476659

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Project description:BackgroundEvidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking.MethodsWe conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months.ResultsAll 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001). There were no significant between-group differences in serious adverse events.ConclusionsA high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).

Project description:BackgroundBariatric surgery is an effective intervention for obesity, but it requires comprehensive postoperative self-management to achieve optimal outcomes. While patient portals are generally seen as beneficial in engaging patients in health management, the link between their use and post-bariatric surgery weight loss remains unclear.ObjectiveThis study investigated the association between patient portal engagement and postoperative body mass index (BMI) reduction among bariatric surgery patients.MethodsThis retrospective longitudinal study included patients who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at Vanderbilt University Medical Center (VUMC) between January 2018 and March 2021. Using generalized estimating equations, we estimated the association between active days of postoperative patient portal use and the reduction of BMI percentage (%BMI) at 3, 6, and 12 months post-surgery. Covariates included duration since surgery, the patient's age at the time of surgery, gender, race and ethnicity, type of bariatric surgery, severity of comorbid conditions, and socioeconomic disadvantage.ResultsThe study included 1,415 patients, mostly female (80.9%), with diverse racial and ethnic backgrounds. 805 (56.9%) patients underwent RYGB and 610 (43.1%) underwent SG. By one-year post-surgery, the mean (SD) %BMI reduction was 31.1% (8.3%), and the mean (SD) number of patient portal active days was 61.0 (41.2). A significantly positive association was observed between patient portal engagement and %BMI reduction, with variations revealed over time. Each 10-day increment of active portal use was associated with a 0.57% ([95% CI: 0.42- 0.72], P < .001) and 0.35% ([95% CI: 0.22- 0.49], P < .001) %BMI reduction at 3 and 6 months postoperatively. The association was not statistically significant at 12 months postoperatively (β=-0.07, [95% CI: -0.24- 0.09], P = .54). Various portal functions, including messaging, visits, my record, medical tools, billing, resources, and others, were positively associated with %BMI reduction at 3- and 6-months follow-ups.ConclusionsGreater patient portal engagement, which may represent stronger adherence to postoperative instructions, better self-management of health, and enhanced communication with care teams, was associated with improved postoperative weight loss. Future investigations are needed to identify important portal features that contribute to the long-term success of weight loss management.

Project description:ObjectivesThe objectives of this study were to determine whether a technology-enhanced weight-loss program, using a home pet health technology ecosystem, is an effective tool in feline weight-loss management in multiple-cat households and to evaluate its impact on cat behavior.MethodsThe study was a prospective parallel unmasked block-randomized controlled trial comparing two weight loss intervention groups: (1) traditional group with dietary restriction alone (n = 9); (2) technology group that used dietary restriction, digital scales, smart feeders, activity monitors and pet treat cameras (n = 6). A 12-week weight-loss program of client-owned indoor-only two- or three-cat households with at least one overweight cat was conducted in Canada and the USA. Owner impressions of the technology, weight loss rates, smart feeder data, activity monitor data and health-related quality of life (HRQoL) were assessed.ResultsThe study was completed by 9/15 traditional group and 6/10 technology group cats. Dropouts were mainly due to owner issues unrelated to the study. The pet health technology ecosystem received favorable reviews (six responders). Smart feeders and home scales were perceived as valuable additions, while activity monitors and pet treat cameras were valued lower. The average weekly weight-loss rate (percent loss of initial body weight) was higher (P = 0.036) in the technology group (0.694%) than in the traditional group (0.175%). Although not associated with weight-loss rates, technology group cats trended toward grazing feeding patterns and decreased daily activity counts, while HRQoL increased, on average, for all cats.Conclusions and relevanceThis introductory investigation suggests that a technology-enhanced weight-loss program would be accepted by cat owners and may deliver advantageous outcomes in multiple-cat households, providing an effective and practical tool in feline weight-loss strategies that will continue to evolve as new technologies become available. It also illustrates the potential value of data gathered from home monitoring devices and digital diaries, providing deeper insights into pet behavior.

Project description:BackgroundDue to the persistence of tobacco-related health disparities in the U.S., there is a need for innovative strategies to reach the underserved ethnic minority populations who are most at risk. As contemplations for health behavior modification tend to surge on Mondays, we explored the feasibility and effect of a Monday-enhanced smoking cessation program on quitting outcomes in a low-income ethnic minority community.AimsTo compare a Monday-enhanced with a standard Communities Engaged and Advocating for a Smoke-free Environment (CEASE) program and understand the overall experiences of participants in the program.MethodsIn this mixed-methods study, affordable housing complexes (n = 4) and a church were randomly assigned either a Monday-enhanced (n = 3) or standard (n = 2) CEASE smoking cessation program. CEASE comprised twelve weekly group counseling sessions facilitated by trained peer motivators plus nicotine replacement products. Participants in the Monday-enhanced arm were encouraged to pick Mondays as a quitting day. Quantitative and qualitative data were collected during the program and at 3-month post-graduation.ResultsSeventy-seven participants were enrolled in the study arms. In both groups combined, tobacco consumption reduced from 7.7 to 5.6 cig/day (mean reduction, 2.1; 95% CI: 0.9 to 5.1, p = 0.08). Although no significant difference in quit rate was observed between the two arms, more participants completed the follow-up survey in the Monday-enhanced than standard CEASE program [82.4% vs. 36.0%, p < 0.05]. While qualitative data suggested an overall satisfaction of participants with the program, motivation for quitting was higher in the Monday-enhanced CEASE program compared to the standard CEASE program.ConclusionThe Monday-enhanced program is promising and may enhance participants' engagement and willingness to quit smoking, particularly in low-income ethnic minority communities. Further research should include larger sample sizes to better assess the efficacy of a Monday-enhanced program across diverse populations.

Project description:The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months.At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level.Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.clinicaltrials.gov Identifier: NCT00842426.

Project description:BackgroundHome blood pressure (BP) monitoring is recommended for people with hypertension; however, meta-analyses have demonstrated that BP improvements are related to additional coaching support in combination with self-monitoring, with little or no effect of self-monitoring alone. High-contact coaching requires substantial resources and may be difficult to deliver via human coaching models.ObjectiveThis observational study assessed changes in BP and body weight following participation in a fully digital program called Lark Hypertension Care with coaching powered by artificial intelligence (AI).MethodsParticipants (N=864) had a baseline systolic BP (SBP) ≥120 mm Hg, provided their baseline body weight, and had reached at least their third month in the program. The primary outcome was the change in SBP at 3 and 6 months, with secondary outcomes of change in body weight and associations of changes in SBP and body weight with participant demographics, characteristics, and program engagement.ResultsBy month 3, there was a significant drop of -5.4 mm Hg (95% CI -6.5 to -4.3; P<.001) in mean SBP from baseline. BP did not change significantly (ie, the SBP drop maintained) from 3 to 6 months for participants who provided readings at both time points (P=.49). Half of the participants achieved a clinically meaningful drop of ≥5 mm Hg by month 3 (178/349, 51.0%) and month 6 (98/199, 49.2%). The magnitude of the drop depended on starting SBP. Participants classified as hypertension stage 2 had the largest mean drop in SBP of -12.4 mm Hg (SE 1.2 mm Hg) by month 3 and -13.0 mm Hg (SE 1.6 mm Hg) by month 6; participants classified as hypertension stage 1 lowered by -5.2 mm Hg (SE 0.8) mm Hg by month 3 and -7.3 mm Hg (SE 1.3 mm Hg) by month 6; participants classified as elevated lowered by -1.1 mm Hg (SE 0.7 mm Hg) by month 3 but did not drop by month 6. Starting SBP (β=.11; P<.001), percent weight change (β=-.36; P=.02), and initial BMI (β=-.56; P<.001) were significantly associated with the likelihood of lowering SBP ≥5 mm Hg by month 3. Percent weight change acted as a mediator of the relationship between program engagement and drop in SBP. The bootstrapped unstandardized indirect effect was -0.0024 (95% CI -0.0052 to 0; P=.002).ConclusionsA hypertension care program with coaching powered by AI was associated with a clinically meaningful reduction in SBP following 3 and 6 months of program participation. Percent weight change was significantly associated with the likelihood of achieving a ≥5 mm Hg drop in SBP. An AI-powered solution may offer a scalable approach to helping individuals with hypertension achieve clinically meaningful reductions in their BP and associated risk of cardiovascular disease and other serious adverse outcomes via healthy lifestyle changes such as weight loss.

Dataset Information

Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial.

Publications

Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial.

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