Clinical trial NCT01625910: For the Health of Our Children--Clinic Based Treatment of Childhood Obesity
Official title: For the Health of Our Children--Clinic Based Treatment of Childhood Obesity: The Feasibility of Recruitment and the Effectiveness of a Low-intensity Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Childhood obesity treatment
Motivational interviewing
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index Z-score Change
timeFrame: Three months
Secondary outcomes:
measure: Sugar Sweetened Beverages
timeFrame: Three months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Fairview Children's Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Steven D Stovitz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: