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1.
JAMA Netw Open ; 7(5): e2412192, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38771575

ABSTRACT

Importance: Evidence-based weight management treatments (WMTs) are underused; strategies are needed to increase WMT use and patients' weight loss. Objective: To evaluate the association of a primary care-based weight navigation program (WNP) with WMT use and weight loss. Design, Setting, and Participants: This cohort study comprised a retrospective evaluation of a quality improvement program conducted from October 1, 2020, to September 30, 2021. Data analysis was performed from August 2, 2022, to March 7, 2024. Adults with obesity and 1 or more weight-related condition from intervention and control sites in a large academic health system in the Midwestern US were propensity matched on sociodemographic and clinical factors. Exposure: WNP, in which American Board of Obesity Medicine-certified primary care physicians offered weight-focused visits and guided patients' selection of preference-sensitive WMTs. Main Outcomes and Measures: Primary outcomes were feasibility measures, including rates of referral to and engagement in the WNP. Secondary outcomes were mean weight loss, percentage of patients achieving 5% or more and 10% or more weight loss, referral to WMTs, and number of antiobesity medication prescriptions at 12 months. Results: Of 264 patients, 181 (68.6%) were female and mean (SD) age was 49.5 (13.0) years; there were no significant differences in demographic characteristics between WNP patients (n = 132) and matched controls (n = 132). Of 1159 WNP-eligible patients, 219 (18.9%) were referred to the WNP and 132 (11.4%) completed a visit. In a difference-in-differences analysis, WNP patients lost 4.9 kg more than matched controls (95% CI, 2.11-7.76; P < .001), had 4.4% greater weight loss (95% CI, 2.2%-6.4%; P < .001), and were more likely to achieve 5% or more weight loss (odds ratio [OR], 2.90; 95% CI, 1.54-5.58); average marginal effects, 21.2%; 95% CI, 8.8%-33.6%) and 10% or more weight loss (OR, 7.19; 95% CI, 2.55-25.9; average marginal effects, 17.4%; 95% CI, 8.7%-26.2%). Patients in the WNP group were referred at higher rates to WMTs, including bariatric surgery (18.9% vs 9.1%; P = .02), a low-calorie meal replacement program (16.7% vs 3.8%; P < .001), and a Mediterranean-style diet and activity program (10.6% vs 1.5%; P = .002). There were no between-group differences in antiobesity medication prescribing. Conclusions and Relevance: The findings of this cohort study suggest that WNP is feasible and associated with greater WMT use and weight loss than matched controls. The WNP warrants evaluation in a large-scale trial.


Subject(s)
Obesity , Primary Health Care , Weight Loss , Weight Reduction Programs , Humans , Female , Male , Primary Health Care/statistics & numerical data , Retrospective Studies , Middle Aged , Adult , Obesity/therapy , Weight Reduction Programs/methods , Weight Reduction Programs/statistics & numerical data , Patient Navigation , Quality Improvement , Cohort Studies
2.
JAMA ; 2024 May 22.
Article in English | MEDLINE | ID: mdl-38776113

ABSTRACT

This study uses data from US retail pharmacies to assess national GLP-1RA dispensing to adolescents and young adults from 2020-2023.

3.
JAMA Netw Open ; 7(2): e2356183, 2024 Feb 05.
Article in English | MEDLINE | ID: mdl-38358738

ABSTRACT

Importance: Among individuals with obesity, 5% or greater weight loss can improve health. Weight management treatments (WMT) include nutrition counseling, very low-calorie meal replacement (MR), antiobesity medications (AOM), and bariatric surgery; however, little is known about how these WMT are associated with weight change among individual patients and populations. Objective: To characterize weight status and WMT use among primary care patients and assess associations between WMT and weight trajectories. Design, Setting, and Participants: Retrospective, population-based cohort study of primary care patients from 1 academic health system in Michigan between October 2015 and March 2020 using cross-sectional analysis to compare obesity prevalence and WMT utilization. For patients with obesity and WMT exposure or matched controls, a multistate Markov model assessing associations between WMT and longitudinal weight status trajectories was used. Data were analyzed from October 2021 to October 2023. Exposures: Cross-sectional exposure was year: 2017 or 2019. Trajectory analysis exposures were WMT: nutrition counseling, MR, AOM, and bariatric surgery. Main Outcomes and Measures: Cross-sectional analysis compared mean body mass index (BMI), obesity prevalence, and, among patients with obesity, prospective WMT use. The trajectory analysis examined longitudinal weight status using thresholds of ±5% and 10% of baseline weight with primary outcomes being the 1-year probabilities of 5% or greater weight loss for each WMT. Results: Adult patients (146 959 participants) consisted of 83 636 female participants (56.9%); 8940 (6.1%) were Asian, 14 560 (9.9%) were Black, and 116 664 (79.4%) were White. Patients had a mean (SD) age of 49.6 (17.7) years and mean (SD) BMI of 29.2 (7.2). Among 138 682 patients, prevalence of obesity increased from 39.2% in 2017 to 40.7% in 2019; WMT use among patients with obesity increased from 5.3% to 7.1% (difference: 1.7%; 95% CI, 1.3%-2.2%). In a multistate model (10 180 patients; 33 549 patient-years), the 1-year probability of 5% or greater weight loss without WMT exposure was 15.6% (95% CI, 14.3%-16.5%) at reference covariates. In contrast, the probability of 5% or greater weight loss was more likely with year-long exposures to any WMT (nutrition counseling: 23.1%; 95% CI, 21.3%-25.1%; MR: 54.6%; 95% CI, 46.5%-61.2%; AOM: 27.8%; 95% CI, 25.0%-30.5%; bariatric surgery: 93.0%; 95% CI, 89.7%-95.0%). Conclusions and Relevance: In this cohort study of primary-care patients with obesity, all WMT increased the patient-level probability of achieving 5% or greater weight loss, but current rates of utilization are low and insufficient to reduce weight at the population level.


Subject(s)
Anti-Obesity Agents , Body-Weight Trajectory , Adult , Humans , Female , Middle Aged , Cohort Studies , Cross-Sectional Studies , Prospective Studies , Retrospective Studies , Obesity/epidemiology , Obesity/therapy , Weight Loss , Primary Health Care
4.
Front Nutr ; 10: 1069266, 2023.
Article in English | MEDLINE | ID: mdl-37266128

ABSTRACT

Introduction: All Veterans Affairs (VA) Medical Centers offer the MOVE! Weight Management Program to help patients achieve and maintain a healthy weight through a calorie-restricted, low-fat diet and increased physical activity. Yet, most MOVE! participants do not achieve clinically significant weight loss of ≥5%. A carbohydrate-restricted diet may help more Veterans to achieve ≥5% weight loss. Methods: This was a single-arm explanatory sequential mixed methods pilot study conducted in one VA health care system. Veterans with prediabetes and body mass index ≥25 kg/m2 were invited to participate in a group-based, virtual, very low-carbohydrate Diabetes Prevention Program (VLC-DPP) consisting of 23 sessions over 12 months. Participants were taught to follow a very low-carbohydrate eating pattern, defined as 20-35 grams of net carbohydrates per day. The primary outcomes were measures of feasibility and acceptability, including program uptake and session attendance. Secondary outcomes included change in weight, hemoglobin A1c, lipids, and patient-reported measures of food cravings, stress eating, perceived health status, and motivation. Interviews were conducted at 6 months to identify factors that facilitated or hindered participants' achievement of ≥5% weight loss. Results: Among 108 screened Veterans, 21 enrolled in the study (19%), and 18 were included in the analytic cohort. On average, participants attended 12.4/16 weekly sessions and 3.6/8 bimonthly or monthly sessions. At 12 months, mean percent weight loss was 9.4% (SD = 10.7) with 9 participants (50%) achieving ≥5% weight loss. Three factors facilitated achievement of ≥5% weight loss among 10/16 interviewees: (1) enjoyment of low-carbohydrate foods; (2) careful monitoring of carbohydrate intake; and (3) reduced hunger and food cravings. Three factors hindered achievement of ≥5% weight loss among 6/16 interviewees: (1) food cravings, particularly for sweets; (2) challenges with maintaining a food log; and (3) difficulty with meal planning. Conclusion: A VLC-DPP is feasible and acceptable and shows preliminary efficacy among Veterans with prediabetes. The program's weight loss effectiveness compared to standard MOVE! should be evaluated in a larger-scale trial. Such a program may be offered in addition to the standard MOVE! program to expand the menu of evidence-based lifestyle counseling options for Veterans. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04881890, identifier NCT04881890.

5.
PLoS One ; 18(4): e0284474, 2023.
Article in English | MEDLINE | ID: mdl-37071660

ABSTRACT

BACKGROUND: Primary care patients with obesity seldom receive effective weight management treatment in primary care settings. This study aims to understand PCPs' perspectives on obesity treatment barriers and opportunities to overcome them. STUDY DESIGN: This is an explanatory sequential mixed methods study in which survey data was collected and used to inform subsequent qualitative interviews. SETTINGS AND PARTICIPANTS: PCPs who provide care to adult patients in an academic medical center in the Midwestern US. METHODOLOGY: PCPs (n = 350) were invited by email to participate in an online survey. PCPs were subsequently invited to participate in semi-structured interviews to further explore survey domains. ANALYTIC APPROACH: Survey data were analyzed using descriptive statistics. Interviews were analyzed using directed content analysis. RESULTS: Among 107 survey respondents, less than 10% (n = 8) used evidence-based guidelines to inform obesity treatment decisions. PCPs' identified opportunities to improve obesity treatment including (1) education on local obesity treatment resources (n = 78, 73%), evidence-based dietary counseling strategies (n = 67, 63%), and effective self-help resources (n = 75, 70%) and (2) enhanced team-based care with support from clinic staff (n = 53, 46%), peers trained in obesity medicine (n = 47, 44%), and dietitians (n = 58, 54%). PCPs also desired increased reimbursement for obesity treatment. While 40% (n = 39) of survey respondents expressed interest in obesity medicine training and certification through the American Board of Obesity Medicine, qualitative interviewees felt that pursuing training would require dedicated time (i.e., reduced clinical effort) and financial support. CONCLUSIONS: Opportunities to improve obesity treatment in primary care settings include educational initiatives, use of team-based care models, and policy changes to incentivize obesity treatment. Primary care clinics or health systems should be encouraged to identify PCPs with specific interests in obesity medicine and support their training and certification through ABOM by reimbursing training costs and reducing clinical effort to allow for study and board examination.


Subject(s)
Nutritionists , Physicians, Primary Care , Pneumonia, Pneumocystis , Adult , Humans , Primary Health Care/methods , Obesity/therapy , Surveys and Questionnaires , Comprehensive Health Care , Attitude of Health Personnel , Physicians, Primary Care/psychology
6.
Trials ; 23(1): 827, 2022 Sep 30.
Article in English | MEDLINE | ID: mdl-36176003

ABSTRACT

BACKGROUND: The Center for Disease Control and Prevention's National Diabetes Prevention Program (NDPP) aims to help individuals with prediabetes avoid progression to type 2 diabetes mellitus (T2DM) through weight loss. Specifically, the NDPP teaches individuals to follow a low-fat, calorie-restricted diet and to engage in regular physical activity to achieve ≥ 5% body weight loss. Most NDPP participants, however, do not achieve this weight loss goal, and glycemic control remains largely unchanged. One promising opportunity to augment the NDPP's weight loss and glycemic effectiveness may be to teach participants to follow a very low-carbohydrate diet (VLCD), which can directly reduce post-prandial glycemia and facilitate weight loss by reducing circulating insulin and enabling lipolysis. To date, there have been no high-quality, randomized controlled trials to test whether a VLCD can prevent progression to T2DM among individuals with prediabetes. The aim of this study is to test the effectiveness of a VLCD version the NDPP (VLC-NDPP) versus the standard NDPP. We hypothesize the VLC-NDPP will demonstrate greater improvements in weight loss and glycemic control. METHODS: We propose to conduct a 12-month, 1:1, randomized controlled trial that will assign 300 adults with overweight or obesity and prediabetes to either the NDPP or VLC-NDPP. The primary outcome will be glycemic control as measured by change in hemoglobin A1c (HbA1c) from baseline to 12 months. Secondary outcomes will include percent body weight change and changes in glycemic variability, inflammatory markers, lipids, and interim HbA1c. We will evaluate progression to T2DM and initiation of anti-hyperglycemic agents. We will conduct qualitative interviews among a purposive sample of participants to explore barriers to and facilitators of dietary adherence. The principal quantitative analysis will be intent-to-treat using hierarchical linear mixed effects models to assess differences over time. DISCUSSION: The NDPP is the dominant public health strategy for T2DM prevention. Changing the program's dietary advice to include a carbohydrate-restricted eating pattern as an alternative option may enhance the program's effectiveness. If the VLC-NDPP shows promise, this trial would be a precursor to a multi-site trial with incident T2DM as the primary outcome. TRIAL REGISTRATION: NCT05235425. Registered February 11, 2022.


Subject(s)
Diabetes Mellitus, Type 2 , Prediabetic State , Adult , Blood Glucose , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/prevention & control , Glycated Hemoglobin , Humans , Hypoglycemic Agents , Insulin , Life Style , Lipids , Nitro Compounds , Prediabetic State/complications , Prediabetic State/diagnosis , Prediabetic State/therapy , Propiophenones , Randomized Controlled Trials as Topic , Weight Loss
7.
Prim Health Care Res Dev ; 23: e14, 2022 03 02.
Article in English | MEDLINE | ID: mdl-35234116

ABSTRACT

BACKGROUND: Primary care providers (PCPs) are expected to help patients with obesity to lose weight through behavior change counseling and patient-centered use of available weight management resources. Yet, many PCPs face knowledge gaps and clinical time constraints that hinder their ability to successfully support patients' weight loss. Fortunately, a small and growing number of physicians are now certified in obesity medicine through the American Board of Obesity Medicine (ABOM) and can provide personalized and effective obesity treatment to individual patients. Little is known, however, about how to extend the expertise of ABOM-certified physicians to support PCPs and their many patients with obesity. AIM: To develop and pilot test an innovative care model - the Weight Navigation Program (WNP) - to integrate ABOM-certified physicians into primary care settings and to enhance the delivery of personalized, effective obesity care. METHODS: Quality improvement program with an embedded, 12-month, single-arm pilot study. Patients with obesity and ≥1 weight-related co-morbidity may be referred to the WNP by PCPs. All patients seen within the WNP during the first 12 months of clinical operations will be compared to a matched cohort of patients from another primary care site. We will recruit a subset of WNP patients (n = 30) to participate in a remote weight monitoring pilot program, which will include surveys at 0, 6, and 12 months, qualitative interviews at 0 and 6 months, and use of an electronic health record (EHR)-based text messaging program for remote weight monitoring. DISCUSSION: Obesity is a complex chronic condition that requires evidence-based, personalized, and longitudinal care. To deliver such care in general practice, the WNP leverages the expertise of ABOM-certified physicians, health system and community weight management resources, and EHR-based population health management tools. The WNP is an innovative model with the potential to be implemented, scaled, and sustained in diverse primary care settings.


Subject(s)
Obesity Management , Humans , Obesity/psychology , Obesity/therapy , Pilot Projects , Primary Health Care , Quality Improvement
8.
J Med Internet Res ; 24(2): e31184, 2022 02 02.
Article in English | MEDLINE | ID: mdl-35107429

ABSTRACT

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a leading cause of morbidity and mortality globally, with adverse health consequences largely related to hyperglycemia. Despite clinical practice guideline recommendations, effective pharmacotherapy, and interventions to support patients and providers, up to 60% of patients diagnosed with T2DM are estimated to have hemoglobin A1c (HbA1c) levels above the recommended targets owing to multilevel barriers hindering optimal glycemic control. OBJECTIVE: The aim of this study is to compare changes in HbA1c levels among patients with suboptimally controlled T2DM who were offered the opportunity to use an intermittently viewed continuous glucose monitor and receive personalized low-carbohydrate nutrition counseling (<100 g/day) versus those who received usual care (UC). METHODS: This was a 12-month, pragmatic, randomized quality improvement program. All adult patients with T2DM who received primary care at a university-affiliated primary care clinic (N=1584) were randomized to either the UC or the enhanced care (EC) group. Within each program arm, we identified individuals with HbA1c >7.5% (58 mmol/mol) who were medically eligible for tighter glycemic control, and we defined these subgroups as UC-high risk (UC-HR) or EC-HR. UC-HR participants (n=197) received routine primary care. EC-HR participants (n=185) were invited to use an intermittently viewed continuous glucose monitor and receive low-carbohydrate nutrition counseling. The primary outcome was mean change in HbA1c levels from baseline to 12 months using an intention-to-treat difference-in-differences analysis comparing EC-HR with UC-HR groups. We conducted follow-up semistructured interviews to understand EC-HR participant experiences with the intervention. RESULTS: HbA1c decreased by 0.41% (4.5 mmol/mol; P=.04) more from baseline to 12 months among participants in the EC-HR group than among those in UC-HR; however, only 61 (32.9%) of 185 EC-HR participants engaged in the program. Among the EC-HR participants who wore continuous glucose monitors (61/185, 32.9%), HbA1c was 1.1% lower at 12 months compared with baseline (P<.001). Interviews revealed themes related to EC-HR participants' program engagement and continuous glucose monitor use. CONCLUSIONS: Among patients with suboptimally controlled T2DM, a combined approach that includes continuous glucose monitoring and low-carbohydrate nutrition counseling can improve glycemic control compared with the standard of care.


Subject(s)
Diabetes Mellitus, Type 2 , Mentoring , Adult , Blood Glucose/analysis , Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/diet therapy , Glycated Hemoglobin , Humans , Quality Improvement
10.
Diabetol Metab Syndr ; 13(1): 29, 2021 Mar 10.
Article in English | MEDLINE | ID: mdl-33691751

ABSTRACT

INTRODUCTION: Chronic inflammation is associated with the development, progression and long-term complications of type 2 diabetes. Hyperglycemia is associated with chronic low-grade inflammation, and thus has become the focus of many screening and treatment recommendations. We hypothesize that insulin may also be associated with inflammation and may be an additional factor to consider in screening and treatment. METHODS: This study used National Health and Nutrition Examination Survey data from 2005 to 2010 to analyze the association between fasting insulin and C-reactive protein (CRP). A two-part model was used due to the high number of values reported as 0.1 mg/L. Two models were analyzed, both with and without the addition of waist circumference to other covariates in the model. RESULTS: The final sample included 4527 adults with a mean age of 43.31 years. In the first model, higher fasting insulin was associated with increased odds of CRP > 0.1 mg/L (OR = 1.02, p < .001) and with higher CRP (ß = 0.03, p < .001). In the adjusted model, including waist circumference as a covariate, higher fasting insulin was not associated with CRP > 0.1 mg/L (OR = 1.00, p = .307) but the association between higher fasting insulin and higher continuous CRP remained significant (ß = 0.01, p = .012). CONCLUSION: This study found that higher fasting insulin is associated with higher CRP. These results suggest that treatment approaches that simultaneously decrease insulin levels as well as glucose levels may provide additive anti-inflammatory effects, and therefore may improve long-term outcomes for adults with type 2 diabetes.

11.
Eat Behav ; 36: 101361, 2020 01.
Article in English | MEDLINE | ID: mdl-31923649

ABSTRACT

OBJECTIVES: (1) To identify factors that influence child feeding practices and beliefs among Hispanic mothers in a low-income community; (2) to describe the use of social media, other internet websites, and text messaging among Hispanic mothers; and (3) to explore mothers' perceptions of social media and/or text messaging interventions to prevent childhood obesity. METHODS: Mixed methods descriptive study with a sequential explanatory design. Hispanic mothers (N = 66) from Detroit, Michigan with children between 6 and 36 months of age completed surveys regarding their child feeding practices, the source (s) influencing these practices, and their use of social media, internet, and text messaging. During qualitative interviews (N = 19), we explored mothers' use of social media and internet websites to find child health information as well as mothers' perspectives on social media/internet/text messaging interventions to promote child health. RESULTS: Most survey respondents were between the ages of 20 and 39 years. One-third of mothers breastfed their child for >6 months; 68% did not introduce solids until their child was older than 6 months. The majority (96%) owned a cellphone; 75% used social media at least once daily. Few mothers indicated that social media and other internet websites influenced their child feeding decisions. During qualitative interviews (N = 19), almost all mothers expressed interest in social media and/or text messaging as a tool to communicate information regarding child health and feeding. CONCLUSIONS: Hispanic mothers had high rates of social media use and most desired social media/internet/text messaging interventions to promote child health.


Subject(s)
Breast Feeding/psychology , Feeding Behavior/psychology , Mothers/psychology , Social Media/standards , Adult , Child, Preschool , Female , Hispanic or Latino , Humans , Infant , Surveys and Questionnaires , Young Adult
12.
Acad Pediatr ; 19(1): 51-57, 2019.
Article in English | MEDLINE | ID: mdl-29920332

ABSTRACT

OBJECTIVE: The objectives of this study were to examine differences in body mass index z-score (BMIZ) trajectory during early childhood among children with a younger sibling compared with those without and to test potential mediators. METHODS: This longitudinal cohort study included 6050 participants of the Early Childhood Longitudinal Study, Birth Cohort (ECLS-B). Focal children's weight, height, sibship status, screen time, active play time, family dinner frequency, and diet quality were assessed at 9 months, 24 months, preschool, and kindergarten when available. A piecewise linear regression model was used to examine the association between sibling birth and focal child's subsequent BMIZ trajectory to kindergarten. Mediation by screen time, active play time, family dinner frequency, and diet quality was tested. RESULTS: BMIZ trajectory was lower among children who had a new sibling join the family before kindergarten compared to children who did not have a new sibling join the family by kindergarten. The association was strongest when new sibship occurred when the focal child was 48 to 66 months (b = -0.026, P = .044). The association was not mediated by screen time, active play time, family dinner frequency, or diet quality. CONCLUSION: Among a nationally representative cohort of US children, new sibship before kindergarten was associated with a lower BMIZ trajectory. Several common obesogenic risk factors did not explain the association.


Subject(s)
Body Mass Index , Body-Weight Trajectory , Siblings , Child, Preschool , Cohort Studies , Female , Humans , Infant , Linear Models , Longitudinal Studies , Male , Pediatric Obesity
13.
BMC Obes ; 5: 38, 2018.
Article in English | MEDLINE | ID: mdl-30524743

ABSTRACT

BACKGROUND: Bariatric surgery leads to changes in mental health, quality of life and social functioning, yet these outcomes differ among individuals. In this study, we explore patients' psychosocial experiences following bariatric surgery and elucidate the individual-level factors that may drive variation in psychosocial outcomes. METHODS: Eleven semi-structured focus groups with Michigan Bariatric Surgery Collaborative (MBSC) patients (n = 77). Interviews were audio recorded, transcribed verbatim, and analyzed using a grounded theory approach. Data on participant demographic characteristics were abstracted from the MBSC clinical registry. RESULTS: Most focus group participants were female (89%), white (64%), and married (65%). We identified three major themes: (1) change in self-perception; (2) change in perception by others; and (3) change in relationships. Each theme includes 3 sub-themes, demonstrating a range of positive and negative psychosocial experiences. For example, weight loss led to increased self-confidence among many participants while others described a loss of self-identity. Some noted improved relationships with family or friends while others experienced worsening or even loss of relationships due to perceived jealousy. CONCLUSION: Weight loss following bariatric surgery leads to complex changes in self-perception and inter-personal relationships, which may be proximal mediators of commonly assessed mental health outcomes such as depression. Individuals considering bariatric surgery may benefit from anticipatory guidance about these diverse experiences, and post-surgical longitudinal monitoring should include evaluation for adverse psychosocial events.

14.
Article in English | MEDLINE | ID: mdl-29449958

ABSTRACT

BACKGROUND: Rates of participation in Diabetes Prevention Programs (DPPs) are low. This may be due, in part, to low levels of autonomous motivation (i.e., motivation that arises from internal sources and sustains healthy behaviors over time) to prevent type 2 diabetes (T2DM) among many individuals with prediabetes. Mobile health (mHealth) technologies that incorporate principles from the Self-Determination Theory offer an effective and scalable approach to increase autonomous motivation levels. One promising mobile phone-based application is JOOL Health, which aims to help users connect certain health behaviors (e.g., sleep and diet) with personal values in specific life domains (e.g., family and work). The first aim of this study is to estimate whether JOOL Health can increase autonomous motivation to prevent T2DM among individuals with prediabetes who declined DPP participation. The second aim of this pilot study is to examine the intervention's feasibility and acceptability. METHODS: This is a 12-week, three-arm pilot randomized controlled trial. We will recruit 105 individuals with prediabetes who did not engage in a DPP despite invitation from their health plan to participate in face-to-face or web-based programs at no out-of-pocket-cost. Participants will be randomized to one of three study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to T2DM, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (comparison group); (2) a group that receives the JOOL Health application; and (3) a group that receives the JOOL Health application as well as a Fitbit activity tracker and wireless-enabled scale. Our primary outcome is change in autonomous motivation to prevent T2DM (measured using the Treatment Self-Regulation Questionnaire). We will also collect data related to the intervention's feasibility (recruitment and retention rates) and acceptability (adherence and qualitative experience) as well as changes in psychosocial outcomes, hemoglobin A1c, and weight. DISCUSSION: To our knowledge, this is the first study that aims to promote positive health behaviors among individuals with prediabetes who previously declined to participate in a DPP. Our results will inform a larger trial to test the effect of JOOL Health on clinically relevant outcomes, including weight loss, physical activity, and DPP engagement. TRIAL REGISTRATION: NCT03025607. Registered February 2017.

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