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临床试验/NCT01845480
NCT01845480Unknown不适用

The Wildcat Wellness Coaching Trial: Home-based Obesity Prevention and Health Promotion in Children and Adolescents

Kansas State University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2012年8月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
66
试验地点
2
主要终点
body mass index Z-score

研究概览

简要总结

Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants will be randomly assigned to either healthful eating and physical activity skills coaching or general health education coaching intervention conditions. For both conditions, research assistants will serve as wellness coaches and deliver 12 intervention sessions in the home of each participating child.

Assessments will be completed at baseline, intervention end (3 months), and follow-up (6 months), comprising biomedical and psychosocial measures. Biomedical measurements to be obtained include:

  • body composition (DEXA, tetrapolar bioimpedance, body mass index, waist circumference)
  • blood pressure (automated sphygmomanometer),
  • pulmonary function tests (forced expiratory flow in 1-sec, forced vital capacity, forced expiratory flow at 25-75% of vital capacity),
  • unstimulated whole (mixed) saliva passive drool to detect markers of inflammation,
  • and physical activity levels (7-day accelerometry).

Psychosocial measurements include:

  • fruit and vegetable consumption (Child Dietary Questionnaire)
  • self efficacy,
  • enjoyment
  • quality of life (Peds QL).

Inclusion criteria are:

  • being female
  • aged 8-13 years
  • with parental consent,
  • residing within a 40-minute drive
  • being available for 12 home coaching visits and three lab assessments.

Exclusion criteria are

  • having developmental delay or psychiatric problems,
  • any illness, injury, condition, or disease that would prevent participation in moderate-to-vigorous physical activity,
  • taking weight-altering medications
  • participating in any other health behavior change program.

The objectives of this study are to determine

  • whether both types of the home-based coaching interventions are feasible
  • whether the healthful eating and physical activity skills coaching intervention is more efficacious, relative to the general health education coaching group, in preventing increases in body fat percentage, body mass index percentile, waist circumference, systolic and diastolic blood pressure, and sedentary behavior
  • whether the healthful eating and physical activity skills coaching intervention is more efficacious, relative to the general health education coaching group, in facilitating increases in quality of life, moderate-to-vigorous physical activity, enjoyment of physical activity and fruit and vegetable consumption, and self-efficacy for physical activity and fruit and vegetable consumption.

We hypothesize that the research project will be successful in recruiting and retaining participating families, training research assistants to deliver the intervention components, and that both of the coaching conditions will be well received and appreciated by participating families. We hypothesize that the healthful eating and physical activity skills coaching intervention will be more effective than the support coaching condition in preventing increases in blood pressure, airway dysfunction and adiposity. We expect that both intervention conditions will show improvements to pediatric quality of life measures, but that the healthful eating and physical activity skills coaching intervention will be more effective than general health education coaching condition in increasing physical activity, physical activity enjoyment and self efficacy, fruit and vegetable consumption, and fruit and vegetable enjoyment and self-efficacy.

详细描述

Obesity is associated with increased chronic disease risk, and therefore poses a major public health problem (Lobstein et al., 2004). In 2011, the Centers for Disease Control and Prevention estimated that obesity affects about 12.5 million children and teens, or 17% of the US population. This is a marked increase from the ~5% rate of obesity found in this population in the late 1960s. Barlow (2007) points out that the complexity of obesity prevention lies less in the identification of target health behaviors, and much more in a process of influencing families to change behaviors when habits, culture, and environment promote less physical activity and more energy intake.

Obesity prevention interventions may not be effective or sustainable without impacting home environments (Rosenkranz & Dzewaltowski, 2008). Conwell et al. (2010) suggest that home-based programs may offer significant advantages over center-based programs by offering better accessibility and convenience. Wellness coaching has shown promise for improving health behaviors related to chronic disease (Lawn & Schoo, 2010), but no published study has used a wellness coaching childhood obesity prevention model in the home environment.

The primary aim of this trial is to determine whether the home-based wellness coaching delivery model is feasible as an obesity prevention intervention strategy in the community setting. The secondary objective is to determine the comparative effectiveness of the two wellness coaching interventions.

Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants will be randomly assigned to either healthful eating and physical activity skills coaching or general health education coaching intervention conditions. For both conditions, research assistants will serve as wellness coaches and deliver 12 intervention sessions in the home of each participating child. Assessments will be completed at baseline, intervention end (3 months), and follow-up (6 months), comprising biomedical and psychosocial measures.

We hypothesize that the research project will be successful in recruiting and retaining participating families, training research assistants to deliver the intervention components, and that both of the coaching conditions will be well received and appreciated by participating families. We hypothesize that the healthful eating and physical activity skills coaching intervention will be more effective than the support coaching condition in preventing increases in blood pressure, airway dysfunction and adiposity. We expect that both intervention conditions will show improvements to pediatric quality of life measures, but that the healthful eating and physical activity skills coaching intervention will be more effective than general health education coaching condition in increasing physical activity, physical activity enjoyment and self efficacy, fruit and vegetable consumption, and fruit and vegetable enjoyment and self-efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Being a female aged 8 to 13 years with consenting parent or guardian
  • Family willing to participate in home-based behavioral intervention

排除标准

  • Having developmental delay or psychiatric problems.
  • Having any illness, injury, condition, or disease that would prevent participation in moderate-to-vigorous physical activity.
  • Not living within 40 miles of Kansas State University campus in Manhattan, KS.
  • Taking weight-altering medications, or participating in any other weight control program.

结局指标

主要结局

body mass index Z-score

时间窗: change from baseline BMIz at 6 months

CDC age- and sex-referenced body mass index standardized score

次要结局

  • Quality of life(change from baseline at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard R. Rosenkranz

Associate Professor

Kansas State University

研究点 (2)

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