BackgroundEfforts to recruit and retain participants in clinical trials are challenging, especially in studies that include minority or low-income children. To date, no studies have systematically examined recruitment and retention strategies and their effectiveness in working successfully with this population. We examined strategies employed to recruit or retain minority or low-income children in trials that included an obesity-related behavior modification component.MethodsFirst, completed home-, community-, and school-based trials involving minority or low-income children aged 2–17 years were identified in a search of the ClinicalTrials.gov registry. Second, a PubMed search of identified trials was conducted to locate publications pertinent to identified trials. Recruitment and retention rates were calculated for studies that included relevant information.ResultsOur final analytic sample included 43 studies. Of these, 25 studies reported recruitment or retention strategies, with the amount of information varying from a single comment to several pages; 4 published no specific information on recruitment or retention; and 14 had no publications listed in PubMed. The vast majority (92 %) of the 25 studies reported retention rates of, on average, 86 %. Retention rates were lower in studies that: targeted solely Hispanics or African Americans (vs. mixed races of African Americans, whites, and others); involved children and parents (vs. children only); focused on overweight or obese children (vs. general children), lasted ≥1 year (vs. <1 year), were home or community-based (vs. school-based), included nutrition and physical activity intervention (vs. either intervention alone), had body mass index or other anthropometrics as primary outcome measures (vs. obesity-related behavior, insulin sensitivity, etc.). Retention rates did not vary based on child age, number of intervention sessions, or sample size.ConclusionsVariable amounts of information were provided on recruitment and retention strategies in obesity-related trials involving minority or low-income children. Although reported retention rates were fairly high, a lack of reporting limited the available information. More and consistent reporting and systematic cataloging of recruitment and retention methods are needed. In addition, qualitative and quantitative studies to inform evidence-based decisions in the selection of effective recruitment and retention strategies for trials including minority or low-income children are warranted.

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.

Objective To describe the proportion of children adhering to recommended physical activity and dietary guidelines, and examine demographic and household correlates of guideline adherence. Design Cross-sectional (pre-randomization) data from a behavioral intervention trial designed to prevent unhealthy weight gain in children. Participants Four hundred and twenty-one children (ages 5–10 years) at risk for obesity (body mass index percentile 70–95). Main Outcomes Measured Physical activity (accelerometry), screen time (parent survey), fruit and vegetable and sugar-sweetened beverage intake (24-hour dietary recall). Analysis Proportions meeting guidelines were calculated. Logistic regression examined associations between demographic and household factors and whether children met recommended guidelines for 1) physical activity (≥ 60 minutes/day), 2) screen time (≤ 2 hours/day), 3) fruit/vegetable intake (≥ 5 servings/day), and 4) sugar-sweetened beverage avoidance. Results Few children met more than one guideline. Only 2% met all four recommended guidelines, and 19% met none. Each guideline had unique sociodemographic and domain-specific household predictors (i.e. availability of certain food/beverages, media, and active play/exercise equipment). Conclusions and Implications Families equipped to promote healthy child behavior patterns in one activity or dietary domain may not be in others. Results have implications for the development of interventions to impact children’s weight-related behaviors and growth trajectories. (200)

Using baseline data from a randomized controlled pediatric obesity prevention trial, this study sought to examine general parenting style as a potential moderator of the association between feeding-specific parenting practices and child dietary intake. Four hundred and twenty-one parent-child dyads served as participants (49% girls and 93% mothers). Children were, on average, 6.6 years old and either overweight or at-risk for overweight (mean BMI percentile = 84.9). Data were collected in participants’ homes. Study staff measured children’s height and weight. Parents completed questionnaires designed to assess general parenting styles (authoritative, authoritarian and permissive) and child feeding practices (restriction and monitoring). Child dietary intake was assessed using a 24-hour recall system. Outcomes were daily servings of fruits and vegetables, sugar-sweetened beverages (SSB), and unhealthy snacks. Results were as follows: Permissive parenting was inversely associated with fruit and vegetable consumption, and parental monitoring was inversely associated with SSB consumption. There were no other main effects of parenting style or feeding practice on child dietary consumption. Authoritarian parenting moderated the association between restriction and SSB intake (a marginally significant effect after correcting for multiple comparisons). Restriction was inversely associated with SSB consumption when authoritarianism was high but unassociated with SSB consumption when authoritarianism was low. Findings indicate that the parenting practice of monitoring child dietary intake was associated with more healthful consumption regardless of parenting style; interventions may thus benefit from encouraging parental monitoring. The parenting strategy of restricting child dietary intake, in contrast, was associated with lower SSB intake in the context of higher parental authoritarianism but inconsequential in the context of lower parental authoritarianism. This exploratory finding warrants further investigation.

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 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.

Summary Background Pediatric primary care is an important setting for addressing obesity prevention. Objective The Healthy Homes/Healthy Kids 5‐10 randomized controlled trial evaluated the efficacy of an obesity prevention intervention integrating pediatric primary care provider counseling and parent‐targeted phone coaching. Methods Children aged 5 to 10 years with a BMI between the 70th and 95th percentile and their parents were recruited from pediatric primary care clinics. Participants received well‐child visit provider counseling about obesity and safety/injury prevention and were then randomized to a 14‐session phone‐based obesity prevention (OP; n = 212) or safety and injury prevention contact control (CC; n = 209) intervention. The primary outcome was 12 and 24‐month child BMI percentile. Results There was no overall significant treatment effect on child BMI percentile. Caloric intake was significantly lower among OP compared with CC participants at 12 months (P < .005). In planned subgroup analyses, OP condition girls had significantly lower BMI percentile (P < .05) and BMI z‐score (P < .02) at 12 and 24 months relative to CC girls and were less likely to be overweight (38.0% vs 53.0%, P < .01) or (obese 3.4% vs 8.8%, P < .10) at follow‐up. Conclusions and Relevance An obesity prevention intervention integrating brief provider counseling and parent‐targeted phone counseling did not impact 12 and 24‐month BMI status overall but did have a significant impact on BMI in girls.

Objectives We evaluated eating behaviors and quality of life (QOL) in pre-adolescent children at risk for obesity with and without abdominal pain (AP). Methods Participants were parent-child dyads enrolled in a randomized, controlled obesity prevention trial. The children were between 5 and 10 years of age and at risk for obesity (70th–95th%ile of BMI; n = 420). Parents completed measures of their child’s eating behaviors, quality of life, abdominal pain, and bowel function and their own depression status, concern about child weight, and feeding practices. Children’s height and weight were also measured. Results Children with frequent AP (≥ 2 per month; n=103) were compared to children reporting infrequent AP (< 2 per month; n=312). Age and BMI did not differ between groups, but AP was more prevalent in females. Child emotional overeating and parental depression scores were higher in the frequent AP group (P<0.01), and child QOL was lower (P < 0.01). In multivariable analysis, female gender (OR 2.18; 95% CI 1.20 – 3.97), emotional overeating (OR 2.28; 95% CI 1.37 – 3.81), and parental depression (OR 1.23; 95% CI 1.12 – 1.35) were associated with more frequent AP. Secondary analyses were completed for children who met Rome III criteria for irritable bowel syndrome (IBS). Conclusions Clinicians working with children with AP at risk for obesity should consider assessing for and, when appropriate, addressing parent and child factors that could potentially exacerbate AP.