跳至主要内容
临床试验/NCT00415974
NCT00415974已完成不适用

PACE-PC: Primary Care Management of Adolescent Obesity

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Primary: The primary outcome of this study is to compare at 12 months, the effects of the PACE-PC intervention and enhanced standard care on BMI z-score among obese (> 95 percentile for age) male and female adolescents aged 11 -13.

研究概览

简要总结

This 12-month randomized controlled trial, sponsored by NIH/NCI, aims to reduce BMI in obese adolescents (ages 11 -13) by intervening on physical activity and nutrition behaviors within primary care settings.

PACE-PC is a theory-based stepped care program that enables pediatricians and primary care providers to intervene with obese adolescents to improve their anthropometric, metabolic, physiological, behavioral, and quality of life outcomes over a one-year period. The program integrates clinician counseling, health educator counseling, and phone and mail contact. It supports tailoring to the needs of obese adolescents and family members and promotes improved diet and physical activity behaviors, weight loss, and ultimately weight loss maintenance.

Participants will be randomly assigned to the Enhanced Usual Care or the PACE-PC stepped care condition. The Enhanced Standard Care condition includes an initial visit and counseling by a physician, 3 visits with a health educator, and materials on how to improve weight related behaviors.

The PACE-PC Stepped Care condition includes 3 steps (each lasting 4 months), with the first step being the most intensive:

Step 1 includes: a physician visit, monthly health educator visits, biweekly phone counseling, and weekly dissemination of nutrition and physical activity information

Step 2 includes: a health educator visits every other month, biweekly phone counseling, and weekly dissemination of nutrition and physical activity information

Step 3 includes: monthly phone counseling and weekly dissemination of nutrition and physical activity information

Participants randomized to the PACE-PC condition will be enrolled in Step 1 (the most intensive) for the first 4 months. Depending upon response at the end of Step 1, for the next 4 months adolescents will be triaged to Step 2 (less intensive) or will repeat Step 1. At 8 months, again based upon treatment response, triage will occur to either Step 3 (least intensive) or repetition of the previous step.

详细描述

Obesity in adolescence is becoming increasingly prevalent. Thirty years ago the prevalence of obesity among adolescents aged 12-19 years was approximately 6%. Between 1980 and 1994, the number of children and adolescents meeting criteria for overweight/obese, as defined by a body mass index (BMI) > 95% for children of the same age and gender, increased by 100% in the United States (Ogden, Flegal, Carroll et al., 2002). The increased prevalence of childhood obesity has been universal in all age, gender, and ethnicity classification. As of the year 2002, over 16% of adolescents are obese in the United States (Ogden et al., 2002) and this problem is even more important in selected regions of the country. For example, the California Center for Public Health Advocacy, (2002), reported that the percentage of 5th, 7th, and 9th graders (ages 10 and 15 years) who had a body mass index (BMI) greater than the 95th percentile ranged from 17.3% - 36% depending upon school attended. Overall childhood obesity is increasingly recognized as one of the nation's most important health issues (IOM, 2004).

Obesity affects all parts of the body including the brain, lungs, heart, liver, pancreas, intestines, kidneys, and skeleton. Consequently, children who meet the criteria for obesity are at risk for serious health problems. A lower quality of life has also been shown among children who are overweight (Schwimmer et al., 2003). Adolescent obesity is also a significant predictor of adult obesity (Clark & Lauer, 1993; Mossberg, 1989). Approximately 1/3 of overweight adults are overweight before 20 years of age. An even larger percentage of morbidly obese adults became obese as children (Rimm & Rimm, 1976). Overweight adolescents are the pediatric group carrying the highest risk for childhood obesity persistence into adulthood (Whitaker et al., 1997).

There is strong evidence of the health benefits of physical activity (USDHHS, 1996; Biddle et al., 2004) including improvements in risk of cancer, longevity, cardiovascular diseases, (CVD), CVD risk factors, diabetes, obesity, osteoporosis, immune functioning, and mental health. More recent guidelines from the Dietary Guidelines for Americans (USDHHS, 2005) and the United Kingdom Health Education Authority recommend 60 minutes of daily PA for youth (Biddle et al., 1998; Cavill et al., 2001). Although national survey data in the U.S. indicate that about two-thirds of adolescent boys and about one-half of adolescent girls are meeting an adult-oriented recommendation for vigorous activity (Pate et al., 1994), objective measures suggest less than 40% of teens are meeting the 60 minute guideline (Pate et al., 2002). Females, older adolescents, minorities and disadvantaged youth are even less likely to be meeting this recommendation (USDHHS, 1998).

Poor dietary behaviors are a known risk factor for the development of obesity, as well as for the nation's three leading causes of death: CHD, cancer and stroke. Research supports that a diet rich in fruits and vegetables and low in fat is important in preventing these chronic diseases, and is recommended by the USDA, USDHHS, Surgeon General, NRC, NHLBI, NCI, ACS, and AHA (USDA, 1991; USDA, 1992; National Research Council, 1989; NHLBI, 1990; NHLBI, 1991; NCI, 1991; Weinhouse et al., 1991; AHA, 1988). Although national surveys indicate a decline in the average proportion of calories from total and saturated fat over the past several decades, the CDC estimated in 2000 that only 38% of individuals 2 years and older met the recommendation for total fat intake and 41% of these individuals met the recommendation for saturated fat intake. Simple dietary restriction has not been associated with successful weight control (NAS, 1991) and may even result in a nutritionally inadequate diet. Thus, rather than focusing only on limiting total energy intake, it is important to promote a diet that is nutrient dense: high in vegetables, fruits, grains, and other fiber-rich plant foods, yet low in fat, at a given level of energy intake.

Obesity is a chronic health condition (WHO, 1998). As such, long-term medical management is appropriate, with particular attention to comorbidity development and identification. According to the Institute of Medicine (IOM), primary care is "the provision of integrated, accessible healthcare services by clinicians who are accountable for addressing a large majority of personal healthcare needs, developing a sustained partnership with patients and practicing within the context of family and community" (IOM, 1996)." Various studies have evaluated primary healthcare and found that primary care provides accessible, comprehensive, coordinated, adequately communicated, longitudinal healthcare (Flocke, 1997; Safran et al., 1998; Starfield, 1998). Primary healthcare has been called the "medical home;" and the American Academy of Pediatrics (AAP) (1992, p. 251) describes the "medical home" (with respect to care for infants, children, and adolescents) as: "accessible, continuous, comprehensive, family centered, coordinated, and compassionate"; "delivered or directed by physicians who are able to manage or facilitate essentially all aspects of pediatric care"; and involving physicians who "should be known to the child and family and able to develop a relationship of mutual responsibility and trust." Thus, pediatricians, family physicians and others in primary care have many opportunities to assist with obesity treatment in children.

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
None

入排标准

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

入选标准

  • Males and Females, ages 11-13 who are obese (> 95% Body Mass Index for age and gender). Participants must have:
  • a home telephone and permanent residence with the intent to stay in the San Diego area over the entire study period;
  • willingness to return to the pediatrician for counseling sessions;
  • ability to attend measurement visits at the PACE research office.

排除标准

  • Any prospective participant with any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, obesity hypoventilation syndrome, and orthopedic problems will be excluded from the study.
  • Additionally, participants will also be excluded if they are over 285 pounds (limits of DXA machine), have any pulmonary, cardiovascular or musculoskeletal problem that would limit ability to comply with moderate-level physical activity (e.g. walking), have a history of substance abuse, or other psychiatric disorder that would impair compliance with the study protocol, or are using any medications which alter body weight.
  • Patients in foster care will be ineligible due to difficulty in obtaining follow-up measures should they move from home to home.

结局指标

主要结局

Primary: The primary outcome of this study is to compare at 12 months, the effects of the PACE-PC intervention and enhanced standard care on BMI z-score among obese (> 95 percentile for age) male and female adolescents aged 11 -13.

时间窗: baseline, 4 months, 8 months, 12 months

次要结局

  • Secondary: Secondary outcomes will be: 1) anthropometric measures (BMI, waist circumference, body fat); 2) metabolic and physiological manifestations of obesity (fasting insulin, fasting blood glucose and blood lipid levels); 3) behavioral measurement(baseline, 4 mos, 8 mos, 12 mos)

研究者

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

Kevin Patrick, MD, MS

Professor

University of California, San Diego

研究点 (2)

Loading locations...

相似试验