For the Health of Our Children--Clinic Based Treatment of Childhood Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01625910
First received: April 10, 2012
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Behavioral counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Body Mass Index Z-score Change [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Change in body mass index z-score change over the three month time period


Secondary Outcome Measures:
  • Sugar Sweetened Beverages [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Change in reported intake of sugar sweetened beverages


Enrollment: 72
Study Start Date: September 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: behavioral counseling
Receive counseling via motivational interviewing seeking to encourage health eating habits and increased physical activity
Behavioral: Behavioral counseling
Counseling of parents to improve their child's diet and physical activity
Other Names:
  • Motivational Interviewing
  • Pediatric obesity treatment
Placebo Comparator: Control
Parents receive instructions in school readiness and performance

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

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625910

Locations
United States, Minnesota
Fairview Children's Clinic
Minneapolis, Minnesota, United States, 55414
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Steven D Stovitz, MD, MS University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01625910     History of Changes
Other Study ID Numbers: 1107M02462
Study First Received: April 10, 2012
Results First Received: April 9, 2013
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Childhood obesity treatment
Motivational interviewing

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014