The BestFIT trial: A SMART approach to developing individualized weight loss treatments.

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.

Pediatric Primary Care-Based Obesity Prevention for Parents of Preschool Children: A Pilot Study.

BACKGROUND: The Healthy Homes/Healthy Kids Preschool (HHHK-Preschool) pilot program is an obesity prevention intervention integrating pediatric care provider counseling and a phone-based program to prevent unhealthy weight gain among 2- to 4-year-old children at risk for obesity (BMI percentile between the 50th and 85th percentile and at least one overweight parent) or currently overweight (85th percentile ≤ BMI < 95th percentile). The aim of this randomized, controlled pilot study was to evaluate the feasibility, acceptability, and potential efficacy of the HHHK-Preschool intervention. METHODS: Sixty parent-child dyads recruited from pediatric primary care clinics were randomized to: (1) the Busy Bodies/Better Bites Obesity Prevention Arm or the (2) Healthy Tots/Safe Spots safety/injury prevention Contact Control Arm. Baseline and 6-month data were collected, including measured height and weight, accelerometry, previous day dietary recalls, and parent surveys. Intervention process data (e.g., call completion) were also collected. RESULTS: High intervention completion and satisfaction rates were observed. Although a statistically significant time by treatment interaction was not observed for BMI percentile or BMI z-score, post-hoc examination of baseline weight status as a moderator of treatment outcome showed that the Busy Bodies/Better Bites obesity prevention intervention appeared to be effective among children who were in the overweight category at baseline relative to those who were categorized as at risk for obesity (p = 0.04). CONCLUSIONS: HHHK-Preschool pilot study results support the feasibility, acceptability, and potential efficacy in already overweight children of a pediatric primary care-based obesity prevention intervention integrating brief provider counseling and parent-targeted phone coaching. What's New: Implementing pediatric primary care-based obesity interventions is challenging. Previous interventions have primarily involved in-person sessions, a barrier to sustained parent involvement. HHHK-preschool pilot study results suggest that integrating brief provider counseling and parent-targeted phone coaching is a promising approach.

TeenBP: Development and Piloting of an EHR-Linked Clinical Decision Support System to Improve Recognition of Hypertension in Adolescents.

CONTEXT: Blood pressure (BP) is routinely measured in children and adolescents during primary care visits. However, elevated BP or hypertension is frequently not diagnosed or evaluated further by primary care providers. Barriers to recognition include lack of clinician buy-in, competing priorities, and complexity of the standard BP tables. CASE DESCRIPTION: We have developed and piloted TeenBP- a web-based, electronic health record (EHR) linked system designed to improve recognition of prehypertension and hypertension in adolescents during primary care visits. MAJOR THEMES: Important steps in developing TeenBP included the following: review of national BP guidelines, consideration of clinic workflow, engagement of clinical leaders, and evaluation of the impact on clinical sites. Use of a web-based platform has facilitated updates to the TeenBP algorithm and to the message content. In addition, the web-based platform has allowed for development of a sophisticated display of patient-specific information at the point of care. In the TeenBP pilot, conducted at a single pediatric and family practice site with six clinicians, over a five-month period, more than half of BPs in the hypertensive range were clinically recognized. Furthermore, in this small pilot the TeenBP clinical decision support (CDS) was accepted by providers and clinical staff. Effectiveness of the TeenBP CDS will be determined in a two-year cluster-randomized clinical trial, currently underway at 20 primary care sites. CONCLUSION: Use of technology to extract and display clinically relevant data stored within the EHR may be a useful tool for improving recognition of adolescent hypertension during busy primary care visits. In the future, the methods developed specifically for TeenBP are likely to be translatable to a wide range of acute and chronic issues affecting children and adolescents.

A Review of Primary Care-Based Childhood Obesity Prevention and Treatment Interventions.

Effective obesity prevention and treatment interventions targeting children and their families are needed to help curb the obesity epidemic. Pediatric primary care is a promising setting for these interventions, and a growing number of studies are set in this context. This review aims to identify randomized controlled trials of pediatric primary care-based obesity interventions. A literature search of 3 databases retrieved 2947 publications, of which 2899 publications were excluded after abstract (n=2722) and full-text review (n=177). Forty-eight publications, representing 31 studies, were included in the review. Eight studies demonstrated a significant intervention effect on child weight outcomes (e.g., BMI z-score, weight-for-length percentile). Effective interventions were mainly treatment interventions, and tended to focus on multiple behaviors, contain weight management components, and include monitoring of weight-related behaviors (e.g., dietary intake, physical activity, or sedentary behaviors). Overall, results demonstrate modest support for the efficacy of obesity treatment interventions set in primary care.

Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds.

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 10 year 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.

Enhancing long-term weight loss maintenance: 2 year results from the Keep It Off randomized controlled trial.

OBJECTIVE: The Keep It Off trial evaluated the efficacy of a phone-based weight loss maintenance intervention among adults who had recently lost weight in Minnesota (2007-2010). METHODS: 419 adults who had recently lost ≥ 10% of their body weight were randomized to the "Guided" or "Self-Directed" intervention. Guided participants received a 10 session workbook, 10 biweekly, eight monthly and six bimonthly phone coaching calls, bimonthly weight graphs and tailored letters based on self-reported weights. Self-Directed participants received the workbook and two calls. Primary outcomes are weight change and maintenance (regain of <2.5% of baseline body weight). RESULTS: Mixed model repeated-measures analysis examining weight change revealed a significant time by treatment group interaction (p<0.0085). Guided participants regained significantly less weight than the Self-Directed participants at 12 and 24 months. The odds of 24 month maintenance were 1.37 (95% CI: 0.97-2.03) times greater in the Guided than in the Self-Directed group. When maintenance rates were compared across all follow-ups, there was a consistently higher maintenance rate for Guided participants (HR 1.31, 95% CI: 1.12-1.54). CONCLUSIONS: A sustained, supportive phone- and mail-based intervention promotes weight loss maintenance relative to a brief intervention for participants who have recently lost weight.

Keep it off: a phone-based intervention for long-term weight-loss maintenance.

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.

Maintaining physical activity among older adults: 24-month outcomes of the Keep Active Minnesota randomized controlled trial.

OBJECTIVE: To evaluate the efficacy at 6-, 12-, and 24-month follow-up of Keep Active Minnesota (KAM), a telephone and mail-based intervention designed to promote physical activity (PA) maintenance among currently active adults age 50 to 70. METHOD: Participants who reported having recently increased their MVPA to a minimum of 2d/wk, 30 min/bout, (N=1049) were recruited in 2004 and 2005 from one large managed care organization in Minnesota, and randomly assigned to either treatment (KAM; N=523), or Usual Care (UC; N=526) with PA assessed using the CHAMPS questionnaire, and expressed as kcal/wk energy expenditure. RESULTS: We find a sustained, significant benefit of the intervention at 6, 12 and 24 months. kcal/wk expenditure in moderate or vigorous activities was higher at 6 (p<.03, Cohen's d(6m)=.16), 12 (p<.04, d(12 m)=.13) and 24 months (p<.01, d(24 m)=.16) for KAM participants, compared to UC participants. CONCLUSIONS: The KAM telephone- and mail-based PA maintenance intervention was effective at maintaining PA in both the short-term (6 months) and longer-term (12 and 24 months) relative to usual care.

Population reach and recruitment bias in a maintenance RCT in physically active older adults.

OBJECTIVE: To assess the representativeness of older adults recruited to a physical activity maintenance RCT by conducting sequential comparisons to characterize study sample composition changes occurring between sampling frame construction and study enrollment. METHOD: Study subjects (N = 1049) were 50 to 70 year old men and women who had increased physical activity within the past year recruited from a Midwestern managed care organization. RESULTS: Those responding to an initial mailed screener differed on demographic, behavioral, and SES characteristics from those not responding. Compared with ineligibles, eligible individuals were significantly younger, more highly educated, and more likely to report improved health in the prior year. Compared with eligible individuals who did not enroll, enrollees had generally higher education and income. CONCLUSIONS: Physical activity promotion programs in older adults may have limited reach and substantial volunteer bias. Additional strategies to increase the reach of physical activity interventions into the target population are needed.

A new approach to physical activity maintenance: rationale, design, and baseline data from the Keep Active Minnesota Trial.

BACKGROUND: Since many individuals who initiate physical activity programs are highly likely to return to a sedentary lifestyle, innovative strategies to efforts to increase the number of physically active older adults who successfully maintain beneficial levels of PA for a substantial length of time are needed. METHODS/DESIGN: The Keep Active Minnesota Trial is a randomized controlled trial of an interactive phone- and mail-based intervention to help 50-70 year old adults who have recently increased their physical activity level, maintain that activity level over a 24-month period in comparison to usual care. Baseline, 6, 12, and 24 month measurement occurred via phone surveys with kilocalories expended per week in total and moderate-to-vigorous physical activity (CHAMPS Questionnaire) as the primary outcome measures. Secondary outcomes include hypothesized mediators of physical activity change (e.g., physical activity enjoyment, self-efficacy, physical activity self-concept), body mass index, and depression. Seven day accelerometry data were collected on a sub-sample of participants at baseline and 24-month follow-up. DISCUSSION: The Keep Active Minnesota study offers an innovative approach to the perennial problem of physical activity relapse; by focusing explicitly on physical activity maintenance, the intervention holds considerable promise for modifying the typical relapse curve. Moreover, if shown to be efficacious, the use of phone- and mail-based intervention delivery offers potential for widespread dissemination.