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Behavioral weight loss programs help people achieve clinically meaningful weight losses (8–10% of starting body weight). Despite data showing that only half of participants achieve this goal, a “one size fits all” approach is normative. This weight loss intervention science gap calls for adaptive interventions that provide the “right treatment at the right time for the right person.” Sequential Multiple Assignment Randomized Trials (SMART), use experimental design principles to answer questions for building adaptive interventions including whether, how, or when to alter treatment intensity, type, or delivery. This paper describes the rationale and design of the BestFIT study, a SMART designed to evaluate the optimal timing for intervening with sub-optimal responders to weight loss treatment and relative efficacy of two treatments that address self-regulation challenges which impede weight loss: 1) augmenting treatment with portion-controlled meals (PCM) which decrease the need for self-regulation; and 2) switching to acceptance-based behavior treatment (ABT) which boosts capacity for self-regulation. The primary aim is to evaluate the benefit of changing treatment with PCM versus ABT. The secondary aim is to evaluate the best time to intervene with sub-optimal responders. BestFIT results will lead to the empirically-supported construction of an adaptive intervention that will optimize weight loss outcomes and associated health benefits. [ABSTRACT FROM AUTHOR]

Abstract: Obesity prevention in children offers a unique window of opportunity to establish healthful eating and physical activity behaviors to maintain a healthful body weight and avoid the adverse proximal and distal long-term health consequences of obesity. Given that obesity is the result of a complex interaction between biological, behavioral, family-based, and community environmental factors, intervention at multiple levels and across multiple settings is critical for both short- and long-term effectiveness. The Minnesota NET-Works (Now Everybody Together for Amazing and Healthful Kids) study is one of four obesity prevention and/or treatment trials that are part of the Childhood Obesity Prevention and Treatment (COPTR) Consortium. The goal of the NET-Works study is to evaluate an intervention that integrates home, community, primary care and neighborhood strategies to promote healthful eating, activity patterns, and body weight among low income, racially/ethnically diverse preschool-age children. Critical to the success of this intervention is the creation of linkages among the settings to support parents in making home environment and parenting behavior changes to foster healthful child growth. Five hundred racially/ethnically diverse, two–four year old children and their parent or primary caregiver will be randomized to the multi-component intervention or to a usual care comparison group for a three-year period. This paper describes the study design, measurement and intervention protocols, and statistical analysis plan for the NET-Works trial. [Copyright &y& Elsevier]

Abstract: Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5–10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a Contact Control condition that focuses on safety and injury prevention. The HHHK 5–10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The Contact Control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5–10 trial. [Copyright &y& Elsevier]

Abstract: Long-term weight-loss maintenance is notoriously difficult to achieve and promote. As the novelty of weight loss treatment fades, enthusiasm for diet and exercise tends to wane in the maintenance phase. Given the recognition of obesity as a chronic disorder requiring continued engagement in weight-control behaviors, there is a need to identify cost-effective and supportive therapies that can sustain motivation. In this paper, we describe the study design and baseline characteristics of participants enrolled in a trial to evaluate a program (Keep It Off) developed specifically for weight-loss maintenance using therapeutic phone contact with recent weight losers throughout the period in which they are at highest risk for weight regain. In the Keep It Off randomized clinical trial we are evaluating this phone-based intervention that focuses on key weight-loss maintenance behaviors followed by continued self-monitoring, reporting of weight, feedback, and outreach in members of a Minnesota managed-care organization. The goal of the intervention is to flatten the typical relapse curve. Moreover, data from this trial will inform our understanding of weight-loss maintenance, including predictors and behaviors that increase the likelihood of success over the long term. [Copyright &y& Elsevier]

Severe obesity is a complex, chronic disease affecting nearly 9% of adolescents in the U.S. Although the current mainstay of treatment is lifestyle therapy, pediatric clinical practice guidelines recommend the addition of adjunct anti-obesity medication (AOM), such as phentermine and topiramate. However, guidance regarding when adjunct AOM should be started and how AOM should be used is unclear. Furthermore, an inherent limitation of current treatment guidelines is their "one-size-fits-all" approach, which does not account for the heterogeneous nature of obesity and high degree of patient variability in response to all interventions. This paper describes the study design and methods of a sequential multiple assignment randomized trial (SMART), "SMART Use of Medications for the Treatment of Adolescent Severe Obesity." The trial will examine 1) when to start AOM (specifically phentermine) in adolescents who are not responding to lifestyle therapy and 2) how to modify AOM when there is a sub-optimal response to the initial pharmacological intervention (specifically, for phentermine non-responders, is it better to add topiramate to phentermine or switch to topiramate monotherapy). Critically, participant characteristics that may differentially affect response to treatment will be assessed and evaluated as potential moderators of intervention efficacy. Data from this study will be used to inform the development of an adaptive intervention for the treatment of adolescent severe obesity that includes empirically-derived decision rules regarding when and how to use AOM. Future research will test this adaptive intervention against standard "one-size-fits-all" treatments. [ABSTRACT FROM AUTHOR]