Janicke David M, Sallinen Bethany J, Perri Michael G, Lutes Lesley D, Silverstein Janet H, Huerta Milagros G, Guion Lisa A
Department of Clinical and Health Psychology, University of Florida, College of Public Health and Health Professions, 101 S. Newell Dr., Gainesville, FL 32611, USA.
Contemp Clin Trials. 2008 Mar;29(2):270-80. doi: 10.1016/j.cct.2007.05.005. Epub 2007 May 29.
Project STORY is a 3-arm, randomized, planning and feasibility study assessing the effectiveness of two behavioral weight management interventions in an important and at-risk population, overweight children and their parents in medically underserved rural counties. Participants will include 90 parent-child dyads from rural counties in north central Florida. Families will be randomized to one of three conditions: (a) a Family-Based Behavioral Group Intervention, (b) a Parent-Only Behavioral Group Intervention, and (c) a waitlist control condition. Child and parent participants will be assessed at baseline (month 0), post-treatment (month 4) and follow-up (month 10). Assessment and intervention sessions will be held at Cooperative Extension offices within each local participating county. The primary outcome measure is change in child body mass index (BMI) z-score. Additional key outcome measures include child dietary intake, physical activity, self-esteem, body image, and parent BMI. The goals of the study are to (a) assess the feasibility of recruitment in rural settings, (b) develop and evaluate training protocol for group leaders, (c) determine strategies to increase adherence to monitoring and goal setting protocol, (d) evaluate strategies for participant retention, (e) assess the relative cost-effectiveness of the interventions, (f) assess the acceptability of the intervention to families and Cooperative Extension administrators and personnel, and (g) if successful, estimate the sample size needed for a full-scale trial. This research has potential implications for medically underserved rural communities with limited resources and preventive health care services. If successful, a Parent-Only intervention program may provide a cost-effective and practical intervention for families in underserved rural communities.
“儿童与父母健康生活方式促进研究项目(STORY)”是一项三臂随机规划与可行性研究,旨在评估两种行为体重管理干预措施对一个重要且处于风险中的人群——佛罗里达州中部农村医疗服务不足地区的超重儿童及其父母——的有效性。研究对象将包括来自佛罗里达州中北部农村县的90对亲子。家庭将被随机分配到以下三种情况之一:(a)基于家庭的行为小组干预;(b)仅针对父母的行为小组干预;(c)等待名单对照情况。儿童和父母参与者将在基线期(第0个月)、治疗后(第4个月)和随访期(第10个月)接受评估。评估和干预环节将在每个当地参与县的合作推广办公室进行。主要结局指标是儿童体重指数(BMI)z评分的变化。其他关键结局指标包括儿童饮食摄入量、身体活动、自尊、身体意象以及父母的BMI。该研究的目标是:(a)评估在农村地区招募参与者的可行性;(b)制定并评估小组组长的培训方案;(c)确定提高对监测和目标设定方案依从性的策略;(d)评估参与者保留策略;(e)评估干预措施的相对成本效益;(f)评估干预措施对家庭以及合作推广管理人员和工作人员的可接受性;(g)如果成功,估计进行全面试验所需的样本量。这项研究对资源有限且预防性医疗保健服务不足的农村医疗服务欠缺社区具有潜在意义。如果成功,仅针对父母的干预项目可能为农村医疗服务欠缺社区的家庭提供一种具有成本效益且切实可行的干预措施。