Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415974
Status:
COMPLETED
Last Update Posted:
2012-08-16
First Post:
2006-12-26
Brief Title:
PACE-PC Primary Care Management of Adolescent Obesity
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
PACE-PC Primary Care Management of Adolescent Obesity
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 12-month randomized controlled trial sponsored by NIHNCI 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
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
Detailed Description:
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 overweightobese 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 173 - 36 depending upon school attended Overall childhood obesity is increasingly recognized as one of the nations 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 13 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 US 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 nations 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
How to enable primary care pediatricians family physicians and others in front line clinical settings to successfully intervene with their obese adolescent patients In many geographical areas alternative interventions for adolescent obesity eg specialist care or community-based programs might either be non-existent or difficult to access Thus the role of primary care clinicians may be even more important
Obesity interventions of any type for individuals under the age of 18 years The increase in the prevalence of this health problem is far outstripping medical knowledge regarding treatment in this population
The impact of an intervention like PACE-PC on anthropometric metabolic physiological and behavioral measures and outcomes in obese adolescents Understanding how interventions do-and do not-alter key health related factors associated with obesity is critical to the overall field of pediatric obesity
Whether adherence to and outcomes associated with obesity treatment can be improved through a multi-channel stepped care program like PACE-PC There are no reports in the literature of stepped care approaches to pediatric obesity especially those that incorporate elements of the chronic care model
Whether weight change brought about by one year of a multimodal intervention can be sustained for an additional year through a less intensive maintenance intervention Maintenance of weight status following weight loss is very difficult Exploring methods to accomplish this is important
The cost-effectiveness of interventions such as PACE-PC for obese adolescents If this intervention is to become generalized someone must be willing to pay for it either employers or other entities at risk for healthcare expenses or consumers themselves Increased knowledge about the cost effectiveness of PACE-PC will inform decisions made by these parties
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 13 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 US 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 nations 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
How to enable primary care pediatricians family physicians and others in front line clinical settings to successfully intervene with their obese adolescent patients In many geographical areas alternative interventions for adolescent obesity eg specialist care or community-based programs might either be non-existent or difficult to access Thus the role of primary care clinicians may be even more important
Obesity interventions of any type for individuals under the age of 18 years The increase in the prevalence of this health problem is far outstripping medical knowledge regarding treatment in this population
The impact of an intervention like PACE-PC on anthropometric metabolic physiological and behavioral measures and outcomes in obese adolescents Understanding how interventions do-and do not-alter key health related factors associated with obesity is critical to the overall field of pediatric obesity
Whether adherence to and outcomes associated with obesity treatment can be improved through a multi-channel stepped care program like PACE-PC There are no reports in the literature of stepped care approaches to pediatric obesity especially those that incorporate elements of the chronic care model
Whether weight change brought about by one year of a multimodal intervention can be sustained for an additional year through a less intensive maintenance intervention Maintenance of weight status following weight loss is very difficult Exploring methods to accomplish this is important
The cost-effectiveness of interventions such as PACE-PC for obese adolescents If this intervention is to become generalized someone must be willing to pay for it either employers or other entities at risk for healthcare expenses or consumers themselves Increased knowledge about the cost effectiveness of PACE-PC will inform decisions made by these parties
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None