Behavioral Treatment for Obese Preschoolers
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 2 - 5 |
Updated: | 12/29/2016 |
Start Date: | March 2012 |
End Date: | December 2016 |
Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers
This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic
and home family behavioral intervention (LAUNCH) against 1) motivational interviewing
(attention control; MI) and 2) standard of care (true standard of care control; STC) with
168 children ages 2 to 5 years who meet the criteria for obesity (>95th percentile for body
mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH,
MI) or standard of care. The primary end-point will be change in BMI z-score at the end of
treatment. The investigators will also assess maintenance of treatment gains at 6 and 12
months after treatment, and changes in factors thought to be mechanisms for change in weight
(food intake and activity level), changes in the obesiogenic environment (parent weight,
food intake and activity, and changes in the home food environment) and factors that could
be negatively impacted (parent and child eating and feeding interactions).
and home family behavioral intervention (LAUNCH) against 1) motivational interviewing
(attention control; MI) and 2) standard of care (true standard of care control; STC) with
168 children ages 2 to 5 years who meet the criteria for obesity (>95th percentile for body
mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH,
MI) or standard of care. The primary end-point will be change in BMI z-score at the end of
treatment. The investigators will also assess maintenance of treatment gains at 6 and 12
months after treatment, and changes in factors thought to be mechanisms for change in weight
(food intake and activity level), changes in the obesiogenic environment (parent weight,
food intake and activity, and changes in the home food environment) and factors that could
be negatively impacted (parent and child eating and feeding interactions).
Obesity now affects an estimated 2.8 million children between the ages of 2 and 5 years, as
the prevalence of obesity among preschool school age children has almost tripled from 5% of
the population in 1971-1980 to 13.9% by 2004. Being obese at age 5 confers a 47 times
greater risk of being overweight or obese at age 12. In fact being obese any time between 2
and 5 year increases the risk of remaining overweight or obese as an adult by four times the
risk of nonobese preschoolers. Being obese as a preschooler also increases the risk of a
number of serious health conditions, including a 2.6 times greater risk of developing type 2
diabetes by age 21 years. In fact, the obesity rate among preschoolers is thought to impose
such a cumulative health risk across the life span that children born today, for the first
time in history, are expected to have a shorter life expectancy than their parents by to 2
to 5 years. Early effective treatments for establish obesity during the preschool years have
the potential to change the trajectory of obesity and related co-morbid health condition
across the life-span by reducing obesity and changing the development of lifestyle habits of
diet and exercise at a time when these are being formed. Yet research on interventions to
reduce obesity in preschool children is severely limited and none exist that addresses
established obesity in this age group. Therefore the current study has the potential to have
a significant impact on public health by providing evidence-based treatment for obesity in
preschoolers, a developmental period in which eating and activity patterns are being formed,
that could significantly impact the trajectory of obesity thereby decreasing the population
obesity rates and associated healthcare costs at across the life span. Fortunately,
investigators are on their way to addressing the problem of obesity reduction in already
obese preschoolers. The investigators have developed and conducted a pilot randomized
clinical trial of a treatment program aimed at reducing obesity in already obese preschool
children. The program (Learning about Activity and Understanding Nutrition for Child Health:
LAUNCH) is tailored to the developmental stage of preschool children and produced promising
preliminary results. In the proposed trial a 3 arm, randomized, parallel group design will
test LAUNCH against 1) motivational interviewing (attention control; MI) and 2) standard of
care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the
criteria for obesity (>95th percentile for body mass index; BMI). Participants will be
randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary
end-point will be change in BMI z-score at the end of treatment. The investigators will also
assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in
factors thought to be mechanisms for change in weight (food intake and activity level),
changes in the obesiogenic environment (parent weight, food intake and activity, and changes
in the home food environment) and factors that could be negatively impacted (parent and
child eating and feeding interactions).
the prevalence of obesity among preschool school age children has almost tripled from 5% of
the population in 1971-1980 to 13.9% by 2004. Being obese at age 5 confers a 47 times
greater risk of being overweight or obese at age 12. In fact being obese any time between 2
and 5 year increases the risk of remaining overweight or obese as an adult by four times the
risk of nonobese preschoolers. Being obese as a preschooler also increases the risk of a
number of serious health conditions, including a 2.6 times greater risk of developing type 2
diabetes by age 21 years. In fact, the obesity rate among preschoolers is thought to impose
such a cumulative health risk across the life span that children born today, for the first
time in history, are expected to have a shorter life expectancy than their parents by to 2
to 5 years. Early effective treatments for establish obesity during the preschool years have
the potential to change the trajectory of obesity and related co-morbid health condition
across the life-span by reducing obesity and changing the development of lifestyle habits of
diet and exercise at a time when these are being formed. Yet research on interventions to
reduce obesity in preschool children is severely limited and none exist that addresses
established obesity in this age group. Therefore the current study has the potential to have
a significant impact on public health by providing evidence-based treatment for obesity in
preschoolers, a developmental period in which eating and activity patterns are being formed,
that could significantly impact the trajectory of obesity thereby decreasing the population
obesity rates and associated healthcare costs at across the life span. Fortunately,
investigators are on their way to addressing the problem of obesity reduction in already
obese preschoolers. The investigators have developed and conducted a pilot randomized
clinical trial of a treatment program aimed at reducing obesity in already obese preschool
children. The program (Learning about Activity and Understanding Nutrition for Child Health:
LAUNCH) is tailored to the developmental stage of preschool children and produced promising
preliminary results. In the proposed trial a 3 arm, randomized, parallel group design will
test LAUNCH against 1) motivational interviewing (attention control; MI) and 2) standard of
care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the
criteria for obesity (>95th percentile for body mass index; BMI). Participants will be
randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary
end-point will be change in BMI z-score at the end of treatment. The investigators will also
assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in
factors thought to be mechanisms for change in weight (food intake and activity level),
changes in the obesiogenic environment (parent weight, food intake and activity, and changes
in the home food environment) and factors that could be negatively impacted (parent and
child eating and feeding interactions).
Inclusion Criteria:
- Children ages 2 years 0 months to 5 years 11 months
- BMI percentile at or above the 95th percentile for age- and gender, but no more than
100% above the median BMI for age and gender.
- English-speaking
- Live within 50 miles of Cincinnati Children's Hospital Medical Center (CCHMC)
- Medical clearance from the child's pediatrician to participate.
Exclusion Criteria:
- Medical conditions known to promote obesity (e.g., Prader-Willi syndrome, Cushing's
syndrome)
- Already involved with another weight control program
- Taking weight-affecting medications (e.g., steroids).
- A disability or illness that would preclude them from engaging in at least moderate
intensity physical activity
- Developmental disability
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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