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 trail. This study will extend the relevant literature in a number of ways. First, this is one of the first randomized studies to assess the effectiveness of a community-based weight management intervention for children and families in underserved rural settings. The intervention is tailored to meet the needs of families in Southern, rural communities by addressing barriers to physical activity specific to rural children, illustrating low-fat/low calorie food preparation for Southern, rural cooking, and by discussing strategies for eating away from home. To this end, this project utilizes a respected and valued network in rural communities, the Cooperative Extension, to deliver the weight management program to families in their local communities. Finally, this is one of the first randomized studies to compare the effectiveness of Family-Based versus Parent-Only behavioral interventions targeting children for weight management.
There are a number of additional potential and critical challenges that we expect to face during the feasibility study. Adherence to a self-monitoring protocol is a challenge for children and families, even in the best of circumstances. However, adherence to self-monitoring is highly associated with success in child weight management programs [36
]. Expecting too much from families may ultimately cause frustration and dropout. To help with adherence to self-monitoring, we initially ask children and parents to monitor everything they eat and drink for the first four weeks of the program using “full” monitoring forms. During week five we switch to abbreviated monitoring forms that we developed for this project. This involves monitoring only the high-fat/high-calorie foods and fruits and vegetables, with different versions including measuring amounts versus just circling if food in a particular category was consumed. However, the abbreviated monitoring forms will be implemented earlier in the protocol as needed based on each family’s progress and ability to complete the full monitoring forms.
Children’s adherence to wearing pedometers will be another specific challenge. There will be situations when children will not be able to wear their pedometer, such as when they are participating in organized sporting events due to safety concerns (i.e., basketball, football, softball, soccer). Moreover, pedometers do not accurately capture all physical activity (i.e., bicycling, swimming). Thus we will encourage children and parents to record participation in physical activity (time and intensity) during which they are not able to wear their pedometer. In an effort to help with overall adherence to monitoring of physical activity and dietary intake, we will teach parents to use behavior contracts and positive praise to support and motivate children to complete self-monitoring protocol. We will also provide incentives for completing self-monitoring protocol. All children who complete their self-monitoring protocol on 5 of 7 days will be entered into a drawing for a small prize. We realize that this direct reinforcement is only available to children in the family intervention. However, as part of the purpose of this study is to examine the difference between Family-Based and Parent-Only interventions, we do not expect the direct support from group leaders to children to be equal across groups.
As noted previously, 25% of our participants will be from ethnic minority backgrounds. Unfortunately, recruitment of African American participants for medical research can be difficult [37
]. We plan to meet with community leaders and secure the endorsement of church pastors to give presentations about the importance of our study to the African-American community at churches predominantly attended by African Americans. This culturally-tailored recruitment strategy has been used effectively in previous trails conducted in our lab with women in rural communities. In addition, we will include “culturally-tailored” features to make the intervention approach comfortable and relevant to African American and Hispanic participants. For example, we will incorporate recipes specially tailored to preferences of different ethnic groups (e.g., the use of the “Down-Home Healthy” eating guide [39
], which includes healthy preparation methods for traditional African American foods). Similarly, we have developed a simplified, more user-friendly self-monitoring system using abbreviated monitoring logs and the “stop light” approach.
As census data shows that over 21% of families from participating counties fall below the poverty line, we expect that a significant portion of participating families will be from lower socioeconomic backgrounds. This can have implications on attendance and retention [40
]. A number of strategies already discussed should help overcome potential barriers to effective interventions associated with lower SES backgrounds. Compensation to defer travel costs, individually tailored treatment goals and plans, and abbreviated monitoring forms should help families with limited financial and educational resources. As financial considerations are also important for families, we have developed an example food budget designed to provide food for a family of four for one week. We will also use the group format to discuss strategies for obtaining and purchasing healthier foods on a limited budget. The group intervention format allows group members to problem solve and share ideas related to overcoming barriers to change. We have found that families are more open to suggestions from other participants, and ultimately provide many wonderful insights to address barriers to lifestyle change.
We expect that some families may be disappointed with their assignment to the Parent-Only condition. In addressing the concern of these families, we will first make sure families are well aware of this possible treatment assignment during the consenting process. During the first group session we will invite parents to discuss the pros and cons of the Parent-Only condition. During this discussion, we will use information gathered during previous groups to emphasize a number of potential benefits, including more experience independently implementing the strategies with their child that may ultimately lead to better long-term maintenance, a calmer and quieter group with time away from the family, and greater ease in coordinating schedules.
One potential limitation is that the current program consists of only 12 sessions over the course of 4 months. However, this schedule should provide preliminary information on the feasibility of this design, supporting a full-scale trial with a longer intervention and maintenance sessions. Regardless, this 4-month period may not provide sufficient time to build and encourage long-term behavioral and weight status change. Determining the length of treatment is a balancing act between placing additional demands on family scheduling and the need for sufficient contact with families to build positive lifestyle changes. This is a special challenge for families in rural counties who often have further to travel for weekly group sessions.
As parent modeling has been shown to have a significant impact on children’s dietary intake and physical activity [42
], parent BMI will be assessed at pre- and post-treatment. However, we will not assess parent dietary intake and physical activity at pre- and post-treatment assessment visits. While we acknowledge that information on parent behavior change would help further elucidate mechanisms of change for children, we must balance the benefits of collecting such data against the demands placed on participants. The families are asked to complete a number of assessment measures that take approximately 45 minutes, without these parent assessment measures. Thus, we felt adding these additional measures would be too burdensome. We hope to include assessment of parental lifestyle habits in a larger, future trial.
Compared to previous studies using the Stoplight Diet [22
], the interventions in Project STORY are not setting weekly goals for calorie reduction with child participants. Rather, we encourage children and families to set dietary goals to limit consumption of high-fat/high-sugar “Red Foods” and increase consumption of fruits and vegetables. The feasibility and success of these strategies on weight status change requires careful study and review.
In summary, we expect to gain significant experience from this feasibility study that will ultimately support a larger, full scale trial examining weight management programs in an important and at-risk population, children and families from medically underserved rural areas. A full-scale trial will determine whether a community based intervention delivered to families in rural settings utilizing an existing network such as the Cooperative Extension can have positive impacts on child behavior, weight status and biological markers of diabetes and early cardiovascular disease. This research may have significant implications for medically underserved rural communities where preventive health care services and overall resources are scarce. A cost-effective Parent-Only intervention that impacts the entire family and that is delivered in an existing, respected framework such as the Cooperative Extension Service, may be more cost-effective and practical to implement and sustain over time.