For the Health of Our Children--Clinic Based Treatment of Childhood Obesity
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 4 - 8 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | August 2012 |
For the Health of Our Children--Clinic Based Treatment of Childhood Obesity: The Feasibility of Recruitment and the Effectiveness of a Low-intensity Stage
Childhood obesity is a major public health problem in the U.S. Currently approximately one
in three children is considered overweight or obese. Most overweight children grow to become
overweight adults. It is unclear how effective pediatricians and other primary care
physicians can be in assisting overweight children to normalize their body weight. Expert
guidelines have been established, but are currently untested.
This study will randomize overweight and obese children between the ages of 4 and 8 years
old to either the recommended treatment guidelines or a control (non-intervention) group.
The purpose of this study is to evaluate the ability (a) to recruit overweight children
between the ages of 4 and 8 years old (b) to remeasure the children three months after
enrollment and (c) to reduce childhood obesity via implementation of the recommended
treatment guidelines.
in three children is considered overweight or obese. Most overweight children grow to become
overweight adults. It is unclear how effective pediatricians and other primary care
physicians can be in assisting overweight children to normalize their body weight. Expert
guidelines have been established, but are currently untested.
This study will randomize overweight and obese children between the ages of 4 and 8 years
old to either the recommended treatment guidelines or a control (non-intervention) group.
The purpose of this study is to evaluate the ability (a) to recruit overweight children
between the ages of 4 and 8 years old (b) to remeasure the children three months after
enrollment and (c) to reduce childhood obesity via implementation of the recommended
treatment guidelines.
3. Research Plan:
a. Specific Aims and Hypothesis: In 2007, an expert committee, composed of representatives
from 16 major clinical organizations (including the PI of this proposal), published
recommendations for primary care office-based treatment of childhood obesity. Seeking both
clinical and cost-effectiveness, the recommendations call for staged treatment that starts
with low intensity, and then, if unsuccessful, increases to a higher frequency of visits.
The committee acknowledged that this staged approach "has not been evaluated." Recent
reviews conclude that treatment of childhood obesity can be efficacious. However, most
studies were conducted in highly controlled tertiary care research settings and involved a
large number of direct contact hours (e.g. many with ≥ 35 contact hours). Research
evaluating the translation of these encouraging findings into more real-world clinical
settings has been lacking. Specifically, there is little research assessing (1) the
feasibility of recruitment from primary care clinics or (2) whether low intensity treatment
(i.e. the initial phase of the staged approach recommended by the expert committee) has any
benefit on weight loss.
- Aim #1: To assess the feasibility of recruiting overweight and obese children, ages 4-8
years, from a large, urban pediatric primary care clinic, randomizing them to either
low-intensity treatment or a control group, and then re-measuring them at approximately
3-months from the date of recruitment.
o Our hypothesis is that we will be able to recruit approximately 70 parent/child dyads
and re-measure 80% at 3-months.
- Aim #2: To evaluate whether the proportion of children who decrease their BMI z-score
over a 3-month period is higher in those randomly assigned to the intervention group
compared with those in the control group.
- Our hypothesis is that the intervention will result in a larger proportion of
children decreasing BMI z-score over a 3-month period.
Results from Aims 1 and 2 will be used to plan for an NIH proposal. If the low intensity
treatment of this proposal shows a trend toward improvement over usual care, this will
justify a full scale, R01 trial testing the complete recommendations of the expert
committee. If few subjects in the intervention group have decreasing BMI z-scores, then a
smaller NIH trial would be needed to test an amended low-intensity treatment stage with more
parent/child contact (e.g. emails, home visits, phone calls).
a. Specific Aims and Hypothesis: In 2007, an expert committee, composed of representatives
from 16 major clinical organizations (including the PI of this proposal), published
recommendations for primary care office-based treatment of childhood obesity. Seeking both
clinical and cost-effectiveness, the recommendations call for staged treatment that starts
with low intensity, and then, if unsuccessful, increases to a higher frequency of visits.
The committee acknowledged that this staged approach "has not been evaluated." Recent
reviews conclude that treatment of childhood obesity can be efficacious. However, most
studies were conducted in highly controlled tertiary care research settings and involved a
large number of direct contact hours (e.g. many with ≥ 35 contact hours). Research
evaluating the translation of these encouraging findings into more real-world clinical
settings has been lacking. Specifically, there is little research assessing (1) the
feasibility of recruitment from primary care clinics or (2) whether low intensity treatment
(i.e. the initial phase of the staged approach recommended by the expert committee) has any
benefit on weight loss.
- Aim #1: To assess the feasibility of recruiting overweight and obese children, ages 4-8
years, from a large, urban pediatric primary care clinic, randomizing them to either
low-intensity treatment or a control group, and then re-measuring them at approximately
3-months from the date of recruitment.
o Our hypothesis is that we will be able to recruit approximately 70 parent/child dyads
and re-measure 80% at 3-months.
- Aim #2: To evaluate whether the proportion of children who decrease their BMI z-score
over a 3-month period is higher in those randomly assigned to the intervention group
compared with those in the control group.
- Our hypothesis is that the intervention will result in a larger proportion of
children decreasing BMI z-score over a 3-month period.
Results from Aims 1 and 2 will be used to plan for an NIH proposal. If the low intensity
treatment of this proposal shows a trend toward improvement over usual care, this will
justify a full scale, R01 trial testing the complete recommendations of the expert
committee. If few subjects in the intervention group have decreasing BMI z-scores, then a
smaller NIH trial would be needed to test an amended low-intensity treatment stage with more
parent/child contact (e.g. emails, home visits, phone calls).
Inclusion Criteria:
- any patient at the participating clinic between the ages of 4-8 years who have a BMI
≥ the 85th percentile
Exclusion Criteria:
- emergent health concern
- serious chronic health concern or recent gastrointestinal illness which may have
resulted in weight loss
- on medications known to affect weight
We found this trial at
2
sites
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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