David M. Janicke - US grants

DESCRIPTION (provided by applicant): The epidemic of childhood obesity is a major public health concern. Childhood obesity has been linked to type 2 diabetes, insulin resistance, abnormal glucose tolerance, and other negative health outcomes. Successful treatment of childhood obesity is associated with significant health benefits. Behavioral family-based interventions including both children and parents have been successful in producing weight loss in children. However, the generalizability of these interventions is limited, and there are virtually no randomized trials examining weight loss interventions for children and families in community-based, rural settings. Recent research suggests that exclusively targeting parents in the behavioral treatment of childhood obesity may lead to similar outcomes, and may be more cost-effective than interventions including both children and parents. These two treatment approaches, however, have yet to be compared in a randomized controlled trial (RCT). This feasibility study entails a three arm RCT to test the effectiveness of two group interventions designed to promote weight management in overweight children and their parents in medically underserved, rural settings. Participants will be randomly assigned to a Behavioral Family-Based Intervention (BFI), Behavioral Parent-Based Intervention (BPI), or a Wait List Control (WLC). Both treatment programs will take a behavioral lifestyle approach to modify dietary and physical activity patterns. In the BPI, only parents will attend group meetings, while in the BFI both children and parents will attend group sessions. Both interventions will include 12 sessions over 4-months, with assessment at baseline, post-treatment, and 6-month follow-up (month 10). It is hypothesized that, (a) children in the BFI and BPI will exhibit greater improvements in weight status than children in the WLC at month 10, (b) children in the BPI will exhibit greater improvements in weight status than those in the BFI at month 10, and (c) the BPI will demonstrate greater cost-effectiveness than the BFI. Findings will provide critical information for planning the R18 RCT.

DESCRIPTION (provided by applicant): Children living in rural areas are 25% more likely to be overweight than their metropolitan peers. Little research has focused on strategies to address this disparity. Developing and evaluating cost-effective interventions that positively impact children's long-term weight status and related health parameters are critical to promoting improved health of youth in rural settings. Successful treatment of childhood obesity can yield significant health benefits. Behavioral family-based interventions, including both the child and parent, have demonstrated success in producing weight loss in children. The generalizability of these interventions, however, is limited. Few trials have been conducted in medically underserved community settings. The level of resources needed to deliver effective interventions represents a significant barrier to dissemination into rural community settings. A growing body of research suggests that exclusively targeting parents in the treatment of childhood obesity may be as effective as family-based programs. A parent-only intervention may be a particularly beneficial and cost-effective alternative for rural populations. Data from our pilot lifestyle intervention (R34 DK071555) delivered through Cooperative Extension Service (CES) offices in rural communities suggests that a parent-only intervention may be a cost-effective alternative intervention to family-based programs in these rural settings. The next logical step in this line of research is to evaluate the long-term effects of comprehensive "Family-Based" and "Parent-Only" behavioral interventions on measures of child weight and health status, and cost-effectiveness. The proposed study entails a three arm RCT to test the effectiveness of interventions designed to promote long-term weight management and improved health status in overweight and obese children from medically underserved, rural areas. Children (n = 240), ages 8-12 years, and their parent(s) will be randomly assigned to a Parent-Only (PO), Family-Based (FB), or a Health Education Control (HEC) intervention. Both the PO and FB interventions will take a behavioral lifestyle approach to modify dietary and physical activity patterns. In the PO intervention, only the parent(s) will attend group meetings, while in the FB intervention both the child and parent(s) will attend group sessions. Both the child and parent(s) will attend group sessions in the HEC condition. All interventions will be delivered through CES offices and will include 12 sessions over the course of 4 months, followed by monthly group sessions for the next 8 months. Weight status, metabolic parameters, physical activity, nutritional intake and quality of life will be assessed at baseline, post-treatment (month 12), and follow-up (month 24). We will also evaluate the cost effectiveness of these interventions. It is hypothesized that: (a) children in the PO and FB will exhibit greater improvements in weight status than children in the HEC at months 12 and 24, and (b) the PO will demonstrate greater cost-effectiveness than the FB and HEC. Results may have significant implications for treatment of pediatric obesity in underserved rural areas by identifying a cost-efficient and effective alternative to family-based interventions. PUBLIC HEALTH RELEVANCE: The proposed study will fill a critical gap in the literature regarding translation and dissemination of research from efficacy trials to best practices in community settings - a key objective of the NIH Roadmap Initiative. The study will have important public health implications for the treatment of pediatric obesity in underserved rural settings.

DESCRIPTION (provided by applicant): Almost 25% of preschool age children are overweight or obese. The early childhood home environment created by parents is crucial in establishing the behaviors and practices consistent with energy balance and healthy weight. Unfortunately, less than optimal eating and physical activity patterns are becoming more common in younger children. Addressing these eating and activity patterns during early childhood is vital to reducing risk factors for disease over the life span. Behavioral family-based interventions (BFI) have demonstrated success in facilitating improved weight status in obese elementary school children. These interventions empower parents to be agents of change and teach parenting skills such as differential attention, contingency management, modeling and stimulus control to modify the family environment and help motivate and support their children to adopt healthier eating and physical activity habits. However, little published research has examined the impact of these interventions for overweight and obese preschoolers. Moreover, most weight management trials have consisted of efficacy studies conducted in university medical centers by highly-trained clinical researchers and multidisciplinary teams. Little research has examined the effectiveness of BFI to address childhood obesity in real-world community settings, let alone underserved populations. The problem of childhood obesity is notably pronounced in rural areas, where the prevalence of pediatric obesity is 25% higher relative to non-rural areas. Unfortunately, children and adults of rural areas represent one of the largest medically underserved populations in the country. A next logical step in this line of research is to evaluate the impact on child weight status of a community-based behavioral family intervention tailored for preschool age children and their parents in medically underserved rural settings. We propose to conduct a Community-based Healthy-lifestyle Intervention for Rural Preschoolers (The CHIRP Study), a two-year multi- site randomized controlled trial that evaluates the effectiveness of a BFI designed to promote healthy lifestyle habits and weight management in an important and underserved population, preschool age children and their parents in rural settings. The current study will provide pilot data to develop and support a larger, full-scale tril. Ninety-six child and parent dyads will be randomly assigned to either a 4-month long BFI or a Wait List Control (WLC). Children (ages 3 to 6 years) and their parents assigned to the BFI will participate in 12 in-person group treatment sessions across four months. The BFI will be delivered in rural communities at Cooperative Extension Service offices and will involve simultaneous, but separate treatment groups for both the child and their parent(s). Child BMI z-score, physical activity, nutritional intake, parent BMI, and home environment variables will be assessed at baseline, post-treatment (month 4), and follow-up (month 10). Dyads assigned to the WLC will receive the BFI after the Month 10 assessment. If successful this intervention offers excellent potential for wide spread dissemination to address a pressing health disparity and public health problem. PUBLIC HEALTH RELEVANCE: The proposed study will fill a critical gap in the literature regarding Behavioral Family Interventions and the treatment of obesity for very young children and their families. The study will have important public health implications for the treatment of pediatric obesity in underserved rural settings.

DESCRIPTION (provided by applicant): Childhood obesity represents a major threat to public health. Sleep disturbance represents a significant comorbidity for overweight and obese (OV/OB) youth [(ages 6-12)] potentially contributing to a variety of negative consequences (lower quality of life, metabolic abnormalities) and further weight gain in this vulnerable population. Lack of sleep may contribute to increased weight status via reduced physical activity caused by fatigue; increased food intake caused by more opportunity to eat; cognitive, behavioral or mood impairments; and changes in metabolism that impact appetite or allow the body to conserve energy. Behavioral sleep disorders are more common in OV/OB youth than in general pediatric populations, with approximately 2 out of 3 OV/OB youth having significant problematic sleep behaviors. Behavioral interventions to address behavioral sleep disorders in children are efficacious in improving sleep in very young children. Improving sleep in OV/OB youth may enhance weight outcomes as improved sleep can lead to changes in energy, mood, appetite, motivation, and cues to eat that can augment a behavioral weight management intervention. Unfortunately, no research to date has examined the efficacy of cognitive behavioral treatment for child sleep (CBTcs) to address [behavioral sleep disorders (inadequate sleep hygiene, insufficient sleep syndrome, and insomnia)] in school-aged youth, nor exclusively in OV/OB youth. Preliminary evidence from our team suggests CBTcs holds great promise to improve sleep outcomes in OV/OB youth. However, more methodologically rigorous evaluation that also includes preliminary evaluation of secondary outcomes that could impact long-term weight status outcomes is needed. Thus, as the logical next step in this line of research, we propose to conduct a randomized controlled trial (RCT) that evaluates the efficacy of brief CBTcs to improve sleep in an important high-risk population, OV/OB youth with behavioral sleep disorders. OV/OB youth [(ages 6-12)] with behavioral sleep disorders (n = 60) and their parent(s) will be randomly assigned to [8 sessions] of either CBTcs or an [Educational Control (EC). CBTcs will address behavioral sleep issues in children; EC will address sleep and dietary education and general coping strategies.] Child sleep (total wake time, total sleep time, bed/wake times), height, weight, physical activity, dietary intake, quality of life (QOL), fatigue, and daytime sleepiness will be assessed at baseline, post-treatment, and 3-month follow-up.