PACE-PC: Primary Care Management of Adolescent Obesity
|First Received Date ICMJE||December 26, 2006|
|Last Updated Date||August 15, 2012|
|Start Date ICMJE||February 2008|
|Primary Completion Date||February 2011 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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. [ Time Frame: baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE
||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.|
|Change History||Complete list of historical versions of study NCT00415974 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 [ Time Frame: baseline, 4 mos, 8 mos, 12 mos ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE
||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|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||PACE-PC: Primary Care Management of Adolescent Obesity|
|Official Title ICMJE||PACE-PC: Primary Care Management of Adolescent Obesity|
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.
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.
Although children and adolescents visit physicians less often than other age groups, the amount of contact is extensive. Overweight youth may be even more likely to visit their primary care physician as compared to non-overweight children (Gauthier et al., 2000). In addition, adolescents have indicated a willingness and desire to discuss weight issues with their healthcare provider (Hodgson et al., 1986; Marks et al., 1983).
The American Heart Association and the American Diabetes Association advocate primary care counseling for modifiable coronary artery disease risk factors, including obesity, during preventive health examinations (ADA, 2001; Grundy et al., 1997). In a recent study conducted in two primary care practices in Louisiana (Huang et al., 2004), primary care practitioner counseling on weight loss was well-received by patients and effective in increasing patients' understanding of the negative health impact of obesity. However, also identified in this study was the lack of sufficient guidance on weight management strategies for primary care practitioners. Potential reasons for this deficiency include: insufficient physician confidence, knowledge and counseling skills, as well as lack of time, resources and under use of dietitians contribute to inadequate counseling on diet, physical activity, and weight loss (Yeager et al., 1996) The extent and content of physician counseling about diet, exercise, and weight loss are inadequate (Galuska et al., 1999; Nawaz et al., 2000). This is discouraging given the fact that physician-patient interactions regarding healthy diet habits have been shown to effect change resulting in improved eating habits (USPSTF, 2002) and weight loss (Nawaz, 2000).
Given its potential, it is surprising how little research has been conducted on primary care interventions for obesity in childhood. To our knowledge, a study by Saelens et al., 200 is the only study to date evaluating a primary care-based behavioral therapy program for weight control management in adolescents. One pilot study evaluates the feasibility of introducing a low glycemic index diet at the primary care setting as a primary-care-based therapy (Young et al., 2004). While preliminary data are promising, this treatment only addresses nutritional issues associated with obesity.
The stepped care treatment scheme for chronic disease has been advocated for some time (Black et al., 1984; Brownell, 1992). Usually this strategy is a step-up one with the least intensive, least expensive, and least dangerous approach used first with all individuals. Only non-responders progress to the next most intensive step, followed by additional increases in intervention intensity if subjects fail to respond.
While most stepped care approaches are modeled after the above-described step-up method, the current model advocated by the United States Preventive Services Task Force (USPSTF) and the NHLBI adheres to a step-down approach where all patients begin with the most intensive step followed by less intensive interactions as patients gain self-efficacy and self-management skills. In the USPSTF review of 17 randomized controlled trials of high-intensity (more than monthly face-to-face contact), medium-intensity (monthly face-to-face contact), and low-intensity (less than monthly interpersonal contact) interventions for obesity (McTigue et al., 2003), the most effective treatment methods were of high intensity which combined two to three components (nutrition education, diet and exercise counseling, and behavioral strategies) within the first 3 months of therapy. These methods were able to achieve weight loss ranges from 3 to 5 kilograms at the one year follow-up visit. In addition, the NHLBI obesity management recommendations (NHLBI, 2000) encourage regular and frequent medical follow-up in the first 6 months of therapy followed by a tapered visit frequency schedule. Weight management is an important principle emphasized by the NHLBI, which encourages continued therapeutic modalities during this "maintenance period" (which may continue indefinitely) to prevent regain of weight lost. Structured treatment programs with regular follow-up improve long-term weight loss and maintenance (Perri et al., 1993; Lantz et al., 2003).
Research to date suggests that a primary care-based "stepped-down" care model is palatable and may be efficacious in promoting weight loss on a population scale.
In sum, the proposed study will help fill several gaps in the literature: There is very little known about:
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Study Arm (s)||
|Publications *||Kolodziejczyk JK, Gutzmer K, Wright SM, Arredondo EM, Hill L, Patrick K, Huang JS, Gottschalk M, Norman GJ. Influence of specific individual and environmental variables on the relationship between body mass index and health-related quality of life in overweight and obese adolescents. Qual Life Res. 2015 Jan;24(1):251-61. doi: 10.1007/s11136-014-0745-1. Epub 2014 Jul 1.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2011|
|Primary Completion Date||February 2011 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||11 Years to 13 Years (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00415974|
|Other Study ID Numbers ICMJE||1R01CA121300-01|
|Has Data Monitoring Committee||Yes|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Kevin Patrick, MD, MS, University of California, San Diego|
|Study Sponsor ICMJE||University of California, San Diego|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of California, San Diego|
|Verification Date||August 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP