Sensible Treatment of Obesity in Rural Youth (STORY): Design and methods☆☆
Introduction
The rate of childhood obesity is increasing at an alarming rate. Over 37% of children ages 6 to 11 years are either overweight or at-risk for overweight [1], an increase of over 15% from 2001–02 to 2003–04. Childhood obesity has been linked to type 2 diabetes [2], [3], insulin resistance and abnormal glucose tolerance [4], and cardiovascular risk factors [5], [6], [7]. Obesity-associated annual hospital costs specific to children ages 6 to 17 have increased threefold over the last 20 years [8]. The social and psychological effects of obesity are profound as obese youth are more likely to experience peer victimization, behavior problems, lower self-esteem, and greater body dissatisfaction than their non-overweight peers [9], [10], [11], [12], [13].
Children from rural communities are at particular risk for the deleterious, long-term complications associated with obesity. Families from rural areas are one of the largest medically underserved populations in the country. Rural counties have higher rates of poverty [14] and greater percentages of patients with chronic diseases [15]. Rural communities often lack facilities or the environment to promote healthy lifestyles (e.g., playgrounds, walking paths, exercise gyms). Families are also often required to travel longer distances to meet with friends and attend school than their non-rural counterparts. This can make organizing casual play opportunities for children or quick bike rides to a friend's house more difficult. Quality supermarkets and food outlets are also more dispersed. Thus, high quality food products (i.e., fresh fruits and vegetables) can be more expensive or more difficult to obtain for families in rural areas. In addition, the extended distance needed to travel to medical providers also makes it difficult to coordinate family schedules, which ultimately affects all aspects of health care [16]. These factors add an additional level of barriers that make adopting healthier lifestyles challenging for families in rural communities. Nor surprisingly, compared to their urban counterparts, residents in rural areas engage in fewer healthy lifestyle behaviors related to obesity, such as reducing dietary fat intake and decreasing sedentary activities [17]. Consequently, children and adults living in rural communities have higher rates of obesity [18], [19], [20].
Venues for establishing health promotion programs for families in rural areas are limited. One alternative is the Cooperative Extension Service (CES) network. Nationally, Cooperative Extension is a partnership between the U.S. Department of Agriculture (USDA) and land-grant universities to ensure that “practical applications of research in agriculture, home economics and rural energy” are provided in every county in the United States. Cooperative Extension programs currently provide services to residents across the U.S. The programs of the Florida Cooperative Extension are generally designed by the faculty at the University of Florida in response to community needs as identified by county extension agents and local advisory groups. The CES network offers a unique opportunity in that it provides the infrastructure, stature within rural communities, and knowledge of local communities to support preventive services to families in rural communities.
Behavioral Family-Based interventions including both children and their parent(s) have demonstrated success in producing weight loss in children [21], [22]. While the main focus of behavioral family interventions is to impact the child's weight status, these interventions commonly target both the child and parent for weight loss by including both children and parents in group-based intervention sessions. The existing research is limited, however, with respect to its generalizability to diverse community settings. Most weight management trials have consisted of efficacy studies conducted with middle-class participants and delivered in “optimal” (i.e., academic research) venues with a multidisciplinary team of experts, rather than in “real world”, community settings.
There is a growing body of research suggesting that working only with the parents(s) to encourage changes in their child's dietary and physical activity patterns may lead to similar or greater weight loss for children than Family-Based interventions that work with parents and children together. [23], [24]. Exclusively targeting the parent(s) in behavioral weight-loss interventions for children in rural settings may hold several advantages over Family-Based interventions. Given the extended distance needed to travel to providers for families in rural settings, a Parent-Only intervention may make it easier for families to coordinate schedules allowing for better attendance. Parent-Only interventions may also be more cost-effective as they require less staff and materials, which is critical for rural communities with limited resources. Unfortunately, only one study to date has published data comparing Family-Based and Parent-Only interventions in a randomized controlled trial. Golan et al. reported that children of parents who participated in a Parent-Only intervention targeting weight loss demonstrated greater weight change at post-treatment than children who participated with their parents in the Family-Based intervention program (9.5% versus 2.4% decrease in percentage overweight) [25]. Like most other trials in this area, this intervention was also conducted in an academic health center. Given the scope and seriousness of obesity in rural America, the lack of intervention studies highlights the pressing need for a clinical trial targeting weight management for children and families in underserved rural settings.
Section snippets
Objectives of Project STORY
The primary aim of Project STORY is to evaluate the effects of a Behavioral “Family-Based” intervention and a Behavioral “Parent-Based” intervention, delivered via group contacts to overweight children and/or their parents in rural counties, on children's standardized body mass index. Secondary aims include: (a) examining changes in children's dietary intake, physical activity, self-esteem, and body image, (b) comparing the cost-effectiveness of the Family-Based and Parent-Only interventions,
Overview
The study sample will include 90 overweight or at-risk for overweight children, ages 8–13 years, and their parent(s) from four medically underserved rural counties in North Central Florida. All participants will receive one of two 4-month lifestyle intervention programs, a Behavioral Family-Based intervention or a Behavioral Parent-Based intervention. Within each county approximately 25 to 30 families will be randomly assigned to one of the two treatment programs or to a waitlist control
Interventionists
The interventions in Project STORY will be delivered by Family and Consumer Sciences (FCS) Agents, in collaboration with a post-doctoral clinical psychologist and graduate students in clinical health psychology. FCS agents have a bachelors or masters degree, often with a concentration in nutrition. FCS agents are typically employed by Cooperative Extension offices to deliver nutrition education programs. All interventionists for Project STORY will undergo extensive training and certification in
Data safety monitoring plan
A detailed data and safety monitoring plan and a data safety monitoring officer will be established to oversee the progress of the project. Adverse events will be recorded by program group leaders and reviewed by the primary investigator and the data safety monitoring officer, and the IRB if necessary. Semi-annual reports detailing participant recruitment, retention, and adverse events will be reviewed and discussed with the data safety monitoring officer.
Data management
The Research Project Coordinator (RPC) will serve as the data manager. The RPC, under the supervision of the statistician and the PI, will be responsible for setting up a computerized database. All staff involved in data collection will be trained and certified in the required data collection procedures, including the anthropometric measures (i.e., height and weight). All computerized data files will be automatically backed up daily on a central network hard drive and will be password protected.
Discussion
Project STORY is a three-arm, randomized planning and feasibility study examining the effectiveness of a Family-Based versus Parent-Only behavioral intervention on children's weight status and healthy lifestyle behaviors. The goal of the study, beyond helping participating families in rural communities, is to provide data and information to support a larger, full-scale trial. This study will extend the relevant literature in a number of ways. First, this is one of the first randomized studies
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The study is supported by a grant from the National Institute for Diabetes and Digestive and Kidney Diseases R34 DK071555-01. Additional supplemental funding for the preliminary pilot work for this study was supplied by the Institute for Child and Adolescent Research and Evaluation at the University of Florida.