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View Clinical Trial (Medical Research Study)
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PACE-PC: Primary Care Management of Adolescent Obesity - NCT00415974-92037 (Clinical Trial 159472)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy159472.aspx
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| City: |
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La Jolla |
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State:
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CA |
| Zip Code: |
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92037 |
| Conditions: |
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Obesity - Overweight - Weight Loss - Weight Maintenance |
| Purpose: |
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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.
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| Study summary: |
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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:
- 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 (e.g.,
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. |
| Criteria: |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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. |
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| Study is available at: |
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UCSD La Jolla Building
La Jolla, CA 92037
United States
Primary Contact:
Jill Rybar, MPH
Phone: 858-457-7280 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
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