Protocol for a prospective, randomized, controlled trial of Mental Contrasting with Implementation Intentions (MCII) to enhance the effectiveness of VA's MOVE! weight management program: WOOP (Wish, Outcome, Obstacle, Plan) VA.

INTRODUCTION: Intensive weight management programs are effective but often have low enrollment and high attrition. Lack of motivation is a key psychological barrier to enrollment, engagement, and weight loss. Mental Contrasting with Implementation Intentions (MCII) is a unique imagery technique that increases motivation for behavior change. We describe our study protocol to assess the efficacy and implementation of MCII to enhance the effectiveness of VA's MOVE! or TeleMOVE! weight management programs using a procedure called "WOOP" (Wish, Outcome, Obstacle, Plan) for Veterans. We hypothesize that WOOP+MOVE! or TeleMOVE! (intervention) will lead to greater MOVE!/TeleMOVE! program engagment and consequently weight loss than MOVE!/TeleMOVE! alone (control). METHOD: Veterans are randomized to either the intervention or control. Both arms receive the either MOVE! or TeleMOVE! weight management programs. The intervention group receives an hour long WOOP training while the control group receives patient education. Both groups receive telephone follow up calls at 3 days, 4 weeks, and 2 months post-baseline. Eligible participants are Veterans (ages 18-70 years) with either obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 25 kg/m2) and an obesity-associated co-morbidity. At baseline, 6 and 12 months, we assess weight, diet, physical activity in both groups. The primary outcome is mean percent weight change at 6 months. Secondary outcomes include changes in waist circumference, diet, physical activity, and dieting self-efficacy and engagement in regular physical activity. We assess implementation using the RE-AIM framework. CONCLUSION: If WOOP VA is found to be efficacious, it will be an important tool to facilitate weight management and improve weight outcomes. CLINICAL TRIAL REGISTRATION: NCT05014984.

Implementing weight maintenance with existing staff and electronic health record tools in a primary care setting: Baseline results from the MAINTAIN PRIME trial.

BACKGROUND: There is need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing primary care teams. The goal of MAINTAIN PRIME (Promoting Real (World) IMplEmentation) is to evaluate whether a successful electronic health record (EHR)-based weight maintenance intervention can be adapted to a new clinical setting with primary care staff serving as coaches. METHODS: EHR tools include tracking tools, standardized surveys, and standardized "SmartPhrases" for coaching. Inclusion criteria were age 18-75 years, voluntary 5% weight loss in the past 2 years with prior BMI ≥ 25 kg/m2, and no bariatric procedures in past 2 years. Participants were randomized 1:1 to tailored online coaching with EHR tracking tools (coaching) or EHR tracking tools alone (tracking). RESULTS: We screened 405 individuals between September 2021 and April 2023; 269 participants enrolled (134 coaching; 135 tracking). The most common reason for not enrolling was ineligibility (55%). At baseline, participants were 50.3 (SD 15.02) years old, 66.4% female, and 84% White; 83.7% reported moderate physical activity. Average weight and BMI at baseline were 205.0 (SD 48.9) lbs. and 33.2 (6.8) kg/m2, respectively. Participants lost an average of 10.7% (SD 5.2) of their body weight before enrolling. We recruited 39 primary care coaches over the same period. Conclusion The study successfully identified and recruited primary care patients with recent intentional weight loss for participation in a weight maintenance program that uses EHR-based tools. We also successfully recruited and trained primary care staff as coaches.

Leverage point themes within Dutch municipalities' healthy weight approaches: A qualitative study from a systems perspective.

INTRODUCTION: Despite all efforts of national and local approaches, obesity rates continue to rise worldwide. It is increasingly recognized that the complexity of obesity should be further addressed by incorporating a systems perspective when implementing approaches. Such an approach has four interconnected system levels: events, structures, goals, and beliefs, in which small changes ('leverage points') can lead to substantial changes in the functioning of the entire system. The current research examined the functioning of five Dutch municipalities' healthy weight approaches (HWAs) and the leverage point themes that can be identified in their system. METHODS: Thirty-four semi-structured interviews were conducted with various stakeholders about the HWA, including policy advisors, care professionals, practice professionals, and citizens. An inductive thematic analysis was performed. RESULTS: Three main themes were identified: 1) HWA organization structure, 2) collaboration between professionals, and 3) citizen participation. Across all system levels, we identified leverage point themes. The upper-levels events and structures occurred the most and were explained by underlying goals and beliefs. Leverage point themes regarding "HWA organization structure" were municipal processes, such as perceived impact; diversity of themes, activities, and tasks; network; and communication strategies, such as messages about the HWA. Leverage point themes regarding "collaboration between professionals" were linking pins, indicating central players within the network; motivation and commitment including support base; and stimulating one another to work on the HWA by spurring other professionals into action. Lastly, leverage point themes under "citizen participation" included reaching the target group, e.g., look for entry points; and citizens' motivation, including customization. DISCUSSION: This paper provides unique insights into HWAs' leverage point themes that can lead to substantial changes in how the entire system functions and makes suggestions about underlying leverage points to help stakeholders improve their HWA. Future research could focus on studying leverage points within leverage point themes.

Comparative Effectiveness of Clinical and Community-Based Approaches to Healthy Weight.

OBJECTIVES: The objective was to evaluate if 2 pediatric weight management interventions delivered to Hispanic, low-income children (one in a health center the other in a Young Men's Christian Association) were effective in reducing BMI. We hypothesized that they would be equally effective. METHODS: A total 407 children aged 6 to 12 years with BMI ≥ 85th percentile receiving care at 2 health centers were randomly assigned to a healthy weight clinic (HWC) at the health center or to a modified Healthy Weight and Your Child (M-HWYC) intervention delivered in Young Men's Christian Associations. A total of 4037 children served as the comparison group. We completed a noninferiority test comparing the M-HWYC with the HWC, which was supported if the bounds of the 90% confidence interval (CI) for the difference in percentage of the 95th percentile (%BMIp95) change did not contain what we considered a minimally clinically important difference, on the basis of previous data (0.87). Then, using linear mixed models, we assessed yearly changes in BMI among intervention participants compared with the comparison sites. RESULTS: The mean difference in %BMIp95 between the M-HWYC and the HWC was 0.75 (90% CI: 0.07 to 1.43), which did not support noninferiority. Compared with the comparison sites, per year, children in the HWC had a -0.23 (95% CI: -0.36 to -0.10) decrease in BMI and a -1.03 (95% CI -1.61 to -0.45) %BMIp95 decrease. There was no BMI effect in the M-HWYC. CONCLUSIONS: We were unable to establish noninferiority of the M-HWYC. The HWC improved BMI, offering an effective treatment of those disproportionately affected.

Childhood obesity as a safeguarding issue: positive experiences with the "new home" environment as a treatment for weight management.

OBJECTIVES: Childhood obesity can lead to acute and chronic comorbidities and adult obesity, highlighting the need for prompt intervention. Families and caregivers play a vital role in treatment and when primary interventions fail, this may become a child protection issue. CASE PRESENTATION: We present two cases of severe childhood obesity where targeted lifestyle interventions failed to impact weight status. Both cases feature child welfare involvement with patients coming into the care of the local authority (under s20 of the Children Act 1989). Foster placement resulted in significant weight loss and improved BMI achieved through reduced portions, healthier choices, restricted calories to recommended daily intake for age and increased activity. Physical and emotional wellbeing benefits were observed and improvements in obesity related comorbidities. CONCLUSIONS: Failure to reduce a child's weight alone does not constitute a child protection issue. In severe cases, where maximum intervention has failed and when the child has obesity related comorbidites or at a higher risk of developing them, home environment change should be considered in the child's best interest as a treatment for severe childhood obesity.

Management of Childhood Obesity-Time to Shift from Generalized to Personalized Intervention Strategies.

As a major public health concern, childhood obesity is a multifaceted and multilevel metabolic disorder influenced by genetic and behavioral aspects. While genetic risk factors contribute to and interact with the onset and development of excess body weight, available evidence indicates that several modifiable obesogenic behaviors play a crucial role in the etiology of childhood obesity. Although a variety of systematic reviews and meta-analyses have reported the effectiveness of several interventions in community-based, school-based, and home-based programs regarding childhood obesity, the prevalence of children with excess body weight remains high. Additionally, researchers and pediatric clinicians are often encountering several challenges and the characteristics of an optimal weight management strategy remain controversial. Strategies involving a combination of physical activity, nutritional, and educational interventions are likely to yield better outcomes compared to single-component strategies but various prohibitory limitations have been reported in practice. This review seeks to (i) provide a brief overview of the current preventative and therapeutic approaches towards childhood obesity, (ii) discuss the complexity and limitations of research in the childhood obesity area, and (iii) suggest an Etiology-Based Personalized Intervention Strategy Targeting Childhood Obesity (EPISTCO). This purposeful approach includes prioritized nutritional, educational, behavioral, and physical activity intervention strategies directly based on the etiology of obesity and interpretation of individual characteristics.

Perspectives into the experience of successful, substantial long-term weight-loss maintenance: a systematic review.

Purpose: In light of the increasing prevalence of overweight and obesity, understanding the experiences, strategies and challenges encountered when trying to achieve substantial, sustainable weight loss is an important area to investigate. We systematically evaluated qualitative studies focusing on the accounts of individuals who have achieved sustained weight loss to create a comprehensive picture of the experience of sustainable weight loss. Methods: Included studies were peer-reviewed studies that qualitatively assessed the views and experiences of adults who previously had or currently have overweight or obesity who successfully lost weight and who subsequently maintained or regained weight. The evidence was systematically synthesized, which enabled the formulation of clear themes and recommendations. Results: The 15 chosen studies included the accounts of 294 individuals. We found that continuous monitoring and goal setting, driven by sustained motivation and encouraging experiences, while resisting ever present challenges and enduring discouraging experience encapsulates the experience of sustained, substantial weight loss. Conclusions: This review aims to provide a comprehensive understanding of the experiences, strategies and challenges encountered when trying to achieve substantial, sustained weight loss. Additional research taking into account findings from this review and others of its kind will enhance the formulation of treatment protocols.

Can you see me? Participant experience of accessing a weight management programme via group videoconference to overcome barriers to engagement.

BACKGROUND: Engagement with conventional weight management group programmes is low. OBJECTIVE: To understand participant experience of accessing an adapted programme via videoconference. PARTICIPANTS: Adults with obesity (BMI ≥ 35kg/m2 ), referred to an NHS Dietetics service in Wales, were offered a group videoconference weight management programme as an optional alternative to in-person groups. Thirteen participants (mean age 48.5 ± 20.2 years, 8 female) recruited to two videoconference groups were interviewed. STUDY DESIGN: A Registered Dietitian delivered a behavioural programme using Skype for Business in 10 sessions over 6 months. Participants joined the groups from any Internet-connected device with a webcam. Participant perspectives were audiorecorded in one-to-one, semi-structured interviews. Interviews were transcribed verbatim and thematically analysed using self-determination theory as a theoretical framework. RESULTS: Ten themes were identified, three relating to service engagement and seven relating to behaviour change facilitation. Key themes in engagement included 'reduced burden', described as saving time and travel and 'reduced threat' as participants perceived joining a group from home as less daunting compared to attending in-person. Despite reporting some initial technical difficulties with establishing video and audio connection, participants described beneficial peer support although not physically with other group members. CONCLUSION: Accessing a group weight management programme via videoconference may be the preferred option for some participants, overcoming some of the barriers to access to standard in-person programmes, particularly in rural areas. Participants are able to experience peer support via videoconference. During the COVID-19 pandemic, weight management programmes could utilize videoconference groups to continue to provide support.

Two-year outcomes of Whanau Pakari, a multi-disciplinary assessment and intervention for children and adolescents with weight issues: A randomized clinical trial.

OBJECTIVE: To determine whether 12-month BMI SDS reductions persisted at 24 months in a multi-disciplinary assessment and intervention program for children and adolescents with obesity, and whether secondary outcomes improved. METHODS: This was a community-based 12-month RCT in Aotearoa/New Zealand. Eligible participants were aged 5 to 16 years with BMI ≥98th centile or BMI >91st centile with weight-related comorbidities. The low-intensity control received comprehensive home-based baseline assessments and advice, and 6-monthly follow-up. The high-intensity intervention received the same assessments and advice, but also weekly multidisciplinary sessions. Primary outcome was BMI SDS at 12 months. Secondary outcomes included cardiovascular and metabolic markers. RESULTS: 121 participants (60% of participants at baseline) were assessed at 24 months. BMI SDS reduction at 12 months was lost at 24 months in the modified intention-to-treat analysis [Control -0.03 (95%CI -0.14, 0.09) and Intervention -0.02 (-0.12, 0.08); P = .93]. However, sweet drink intake was reduced, water intake increased, and there were improvements in cardiovascular fitness in the high-intensity intervention. ≥70% attendance in the high-intensity intervention resulted in a persistent BMI SDS reduction of -0.22 after 24 months (95%CI -0.38, -0.06). CONCLUSIONS: This trial was negative in terms of primary outcome at 24 months. However, high engagement led to sustained treatment effect, and there were multiple improvements in health measures.

Class 3 Obesity in a Multidisciplinary Metabolic Weight Management Program: The Effect of Preexisting Type 2 Diabetes on 6-Month Weight Loss.

INTRODUCTION: Class 3 obesity (BMI ≥ 40 kg/m2) is a growing health problem worldwide associated with considerable comorbidity including Type 2 diabetes mellitus (T2DM). The multidisciplinary medical management of obesity can be difficult in T2DM due to potential weight gain from medications including sulphonylureas and insulin. However, newer weight-neutral/losing diabetes medications can aid additional weight loss. The aim of this study was to compare weight loss outcomes of patients with and without T2DM, and in patients with T2DM, to compare diabetes outcomes and change in medications at 6 months. METHODS: All patients entering a multidisciplinary weight management metabolic program in a publicly funded hospital clinic in Sydney between March 2018 and March 2019, with BMI ≥ 40 kg/m2 and aged ≥18 years were included. Data was collected from patient clinical and electronic notes at baseline and 6 months. RESULTS: Of the 180 patients who entered the program, 53.3% had T2DM at baseline. There was no difference in percentage weight loss in those with or without T2DM (4.2 ± 4.9% vs. 3.6 ± 4.7%, p = 0.35). Additionally, T2DM patients benefited from a 0.47% reduction in HbA1c (p < 0.01) and a reduction in the number of medications from baseline to 6 months (1.8 ± 1.0/patient vs. 1.0 ± 1.2/patient, p < 0.001). T2DM patients who started on weigh-neutral/losing medications in the program lost more weight than those started on weight-gaining medications (7.7 ± 5.3% vs. 2.4 ± 3.8%, p = 0.015). CONCLUSIONS: Patients with class 3 obesity had significant weight loss at 6 months in this program. Patients with T2DM at baseline had comparable weight loss at 6 months, a significant improvement in glycaemic control, and a reduction in diabetes medication load. Additionally, patients with T2DM who were started on weight-neutral/losing medications lost significantly more weight than those started on weight-gaining medications, and these medications should be preferentially used in class 3 obesity and comorbid T2DM.

Feasibility of Targeting Hispanic Fathers and Children in an Obesity Intervention: Papás Saludables Niños Saludables.

Background: Hispanic children and men carry a high burden for obesity and associated medical conditions. Healthy Dads Healthy Kids was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among fathers and children in Australia. The aim of this study was to assess the feasibility of a culturally adapted version of the program for Hispanic families, Papás Saludables Niños Saludables. Methods: A randomized waitlist controlled trial with a process evaluation was conducted to assess the feasibility of Papás Saludables Niños Saludables(NCT03532048). Fathers, their partner (mother), and one to three children were enrolled. A priori feasibility criteria were: (1) recruit 40 Hispanic fathers and their families in ≤4 months; (2) retain 80% of participants for pre- and postassessments; (3) maintain ≥70% attendance to the 10 sessions; (4) obtain 80% "excellent" or "good" satisfaction from participants; and (5) collect anthropometric and behavioral data on ≥75% of participants at baseline and follow-up. Results: The study enrolled 90% (n = 36) of the goal from one local pediatric clinic between May and August 2018; retained 75% of participants for postassessment; maintained 72% attendance among those who started the program; and achieved 100% "excellent/good" satisfaction ratings among the participating fathers and mothers. One hundred percent of participants had most anthropometric and behavioral data at baseline and 72% at follow-up. Conclusions: With oversampling and improvements in the recruitment strategies, Papás Saludables Niños Saludables is feasible for a randomized controlled clinical trial to address whether a father-targeted lifestyle program is efficacious among low-income Hispanic men and their children.

DIAL now protocol: A randomized trial examining the provision of phone coaching to those with sub-optimal early weight loss during an Internet weight management program.

BACKGROUND: While low-intensity Internet-delivered weight loss (IDWL) programs are efficacious, many patients fail to achieve clinically significant weight loss (WL). Given the positive association between 4-week and post-treatment WL, providing a more intensive intervention for those with sub-optimal 4-week WL may improve outcomes for a greater proportion of individuals. This stepped-care approach would minimize cost by reserving more aggressive treatment for those with sub-optimal early WL. OBJECTIVE: This randomized trial examines whether the provision of brief or extended phone coaching for those with sub-optimal early WL improves 4- and 12-month WL when compared to no coaching. Secondary aims include examination of cost/kg WL and intervention engagement. METHODS: 450 individuals (age 18-70 years, BMI: 25-45 kg/m2) will be randomized to: 1) IDWL+3 weeks of coaching ('Brief'), 2) IDWL+12 weeks of coaching ('Extended'), or 3) IDWL only ('Control'). All individuals will receive a 4-month IDWL program followed by an 8-month IDWL maintenance program. At week 4, individuals will be classified as early sub-optimal responders (<4% WL) or initial responders (≥4% WL). Individuals with sub-optimal early WL randomized to 'Brief' or 'Extended' will receive 3 and 12 weeks of phone coaching respectively, starting at week 5. Those with sub-optimal early WL randomized to 'Control', and initial responders will not receive any coaching. Assessments will occur at 4 and 12 months. DISCUSSION: Study findings can inform the development of more effective IDWL programs. This model which provides additional support to those with sub-optimal early WL can easily be translated into healthcare and community settings.

The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state.

Diabetes prevalence has risen rapidly and has become a global health challenge. The Diabetes Prevention Program (DPP) has been shown to prevent or delay the development of diabetes among individuals with prediabetes. Yet, diabetes prevention studies within the Medicaid population are limited and results are mixed. This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State. A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. Study participants were offered a 16-week DPP with various incentive strategies based on class attendance and weight loss as follows: Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss. A control group was offered DPP with no incentives for attendance or weight loss. We evaluated the impact of incentives on achievement of the program completion and weight-loss milestone. Participants who received incentives for the Attendance-Only class were least likely to be lost to follow-up, more likely to complete the program, and had two times higher percentage of meeting the weight-loss milestone compared to the control group. Results for the other incentive cohorts were mixed. A strong positive association was observed for participants who attended 9 or more classes and weight-loss regardless of incentive strategies. Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone. However, the results from this study indicate that participant enrollment and retention remained challenges despite the incentives.

The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.

BACKGROUND: Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors. PURPOSE: Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older. METHODS: Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months. CONCLUSIONS: If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.

Insurance Coverage Criteria for Bariatric Surgery: A Survey of Policies.

BACKGROUND: Bariatric surgery remains underutilized at a national scale, and insurance company reimbursement is an important determinant of access to these procedures. We examined the current state of coverage criteria for bariatric surgery set by private insurance companies. METHODS: We surveyed medical policies of the 64 highest market share health insurance providers in the USA. ASMBS guidelines and the CMS criteria for pre-bariatric evaluation were used to collect private insurer coverage criteria, which included procedures covered, age, BMI, co-morbidities, medical weight management program (MWM), psychosocial evaluation, and a center of excellence designation. We derive a comprehensive checklist for pre-bariatric patient evaluation. RESULTS: Sixty-one companies (95%) had defined pre-authorization policies. All policies covered the RYGB, and 57 (93%) covered the LAGB or the SG. Procedures had coverage limited to center of excellence in 43% of policies (n = 26). A total of 92% required a BMI of 40 or above or of 35 or above with a co-morbidity; however, 43% (n = 23) of policies covering adolescents (n = 36) had a higher BMI requirement of 40 or above with a co-morbidity. Additional evaluation was required in the majority of policies (MWM 87%, psychosocial evaluation 75%). Revision procedures were covered in 79% (n = 48) of policies. Reimbursement of a second bariatric procedure for failure of weight loss was less frequently found (n = 41, 67%). CONCLUSIONS: A majority of private insurers still require a supervised medical weight management program prior to approval, and most will not cover adolescent bariatric surgery unless certain criteria, which are not supported by current evidence, are met.

Early Outcomes From the English National Health Service Diabetes Prevention Programme.

OBJECTIVE: To assess weight and HbA1c changes in the Healthier You: National Health Service Diabetes Prevention Programme (NHS DPP), the largest DPP globally to achieve universal population coverage. RESEARCH DESIGN AND METHODS: A service evaluation assessed intervention effectiveness for adults with nondiabetic hyperglycemia (HbA1c 42-47 mmol/mol [6.0-6.4%] or fasting plasma glucose 5.5-6.9 mmol/L) between program launch in June 2016 and December 2018, using prospectively collected, national service-level data in England. RESULTS: By December 2018, 324,699 people had been referred, 152,294 had attended the initial assessment, and 96,442 had attended at least 1 of 13 group-based intervention sessions. Allowing sufficient time to elapse, 53% attended an initial assessment, 36% attended at least one group-based session, and 19% completed the intervention (attended >60% of sessions). Of the 32,665 who attended at least one intervention session and had sufficient time to finish, 17,252 (53%) completed: intention-to-treat analyses demonstrated a mean weight loss of 2.3 kg (95% CI 2.2, 2.3) and an HbA1c reduction of 1.26 mmol/mol (1.20, 1.31) (0.12% [0.11, 0.12]); completer analysis demonstrated a mean weight loss of 3.3 kg (3.2, 3.4) and an HbA1c reduction of 2.04 mmol/mol (1.96, 2.12) (0.19% [0.18, 0.19]). Younger age, female sex, Asian and black ethnicity, lower socioeconomic status, and normal baseline BMI were associated with less weight loss. Older age, female sex, black ethnicity, lower socioeconomic status, and baseline overweight and obesity were associated with a smaller HbA1c reduction. CONCLUSIONS: Reductions in weight and HbA1c compare favorably with those reported in recent meta-analyses of pragmatic studies and suggest likely future reductions in participant type 2 diabetes incidence.

Self-efficacy and Physical Activity in Overweight and Obese Adults Participating in a Worksite Weight Loss Intervention: Multistate Modeling of Wearable Device Data.

BACKGROUND: Physical activity is associated with a reduced risk of numerous types of cancer and plays an important role in maintaining a healthy weight. Wearable physical activity trackers may supplement behavioral intervention and enable researchers to study how determinants like self-efficacy predict physical activity patterns over time. METHODS: We used multistate models to evaluate how self-efficacy predicted physical activity states among overweight and obese individuals participating in a 26-week weight loss program (N = 96). We specified five states to capture physical activity patterns: (i) active (i.e., meeting recommendations for 2 weeks), (ii) insufficiently active, (iii) nonvalid wear, (iv) favorable transition (i.e., improvement in physical activity over 2 weeks), and (v) unfavorable transition. We calculated HRs of transition probabilities by self-efficacy, body mass index, age, and time. RESULTS: The average prevalence of individuals in the active, insufficiently active, and nonvalid wear states was 13%, 44%, and 16%, respectively. Low self-efficacy negatively predicted entering an active state [HR, 0.51; 95% confidence interval (CI), 0.29-0.88]. Obesity negatively predicted making a favorable transition out of an insufficiently active state (HR, 0.61; 95% CI, 0.40-0.91). Older participants were less likely to transition to the nonvalid wear state (HR, 0.53; 95% CI, 0.30-0.93). Device nonwear increased in the second half of the intervention (HR, 1.73; 95% CI, 1.07-2.81). CONCLUSIONS: Self-efficacy is an important predictor for clinically relevant physical activity change in overweight and obese individuals. Multistate modeling is useful for analyzing longitudinal physical activity data. IMPACT: Multistate modeling can be used for statistical inference of covariates and allow for explicit modeling of nonvalid wear.See all articles in this CEBP Focus section, "Modernizing Population Science."

Testing the effectiveness of a weight loss intervention to enhance self-regulation in adults who are obese: protocol for a randomised controlled trial.

INTRODUCTION: Previous trials finding an effect of self-monitoring on weight loss have considered the effect to be mediated by self-regulatory processes. However, a qualitative think-aloud study asking people to record thoughts and feelings during weighing showed that self-regulation occurs only rarely without further instruction. The aim of this trial is to test a novel intervention guiding people through the self-regulatory processes to see whether it facilitates weight loss. METHODS AND ANALYSES: A parallel group, randomised controlled trial will be conducted to test the concept that a self-regulation intervention for weight loss increases weight loss compared with daily self-weighing without further support. One hundred participants with a body mass index ≥30 kg/m2 will be randomised to either the control or intervention group. The control group will be asked to weigh themselves daily for 8 weeks, the intervention group will be encouraged to follow the self-regulation intervention. They will be prompted to weigh daily, track their weight using an app, plan daily actions for weight loss and reflect on their action plans on a weekly basis. This self-regulation cycle will allow them to experiment with different weight loss strategies and identify effective and sustainable actions. Primary and process outcomes will be measured at baseline and 8 weeks' follow-up. Linear regression analysis of the primary outcome, weight change, will assess the early effectiveness of the intervention. The process outcomes liking, perceived effectiveness, as well as usage and barriers with regard to the self-regulation intervention, will be assessed through qualitative analysis of follow-up interviews and quantitative analysis of adherence rates and responses to a final questionnaire. ETHICS AND DISSEMINATION: This trial was reviewed and approved by the NHS National Research Ethics Committee and the Health Research Authority (reference number: 18/SC/0482). The findings of the trial will be published in peer reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN14148239, prerecruitment. PROTOCOL VERSION: Version 1.1, 7 December 2018.

Evaluation of a Digital Diabetes Prevention Program Adapted for Low-Income Patients, 2016-2018.

INTRODUCTION: We examined the effects of a digitally delivered, type 2 diabetes mellitus prevention program (DPP) for a low-income population. METHODS: We conducted a nonrandomized clinical trial with matched controls. The intervention group was offered a digital DPP, a web-based and mobile-based program including 52 weeks of participation in an educational curriculum, health coaching, and peer support. RESULTS: A total of 227 participants enrolled. At baseline, 34.6 was the mean body mass index, and 5.8 was the mean HbA1c. For the intervention group, mean weight loss was 4.4% at the 12-month follow-up. CONCLUSION: The modified DPP successfully engaged participants and resulted in weight loss. Low-income patients with prediabetes benefitted from a digitally delivered diabetes intervention. This prevention method should be accessible to a low-income population.