Childhood Obesity Treatment Targeting Specific Behaviors

NCT00259324 | Completed

• 1 other identifier: 1-R21-DK07491901
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The US is in the midst of an obesity epidemic, affecting young children. The pediatric primary care setting is an ideal place to address this problem since most families have frequent contact with their pediatrician and a child's health status is regularly assessed in this setting. Recommendations for treating children with a body mass index (BMI) over the 85th percentile in the primary care setting have been developed by an Expert Committee on childhood. Programs are needed that meet the recommendations from the Committee, which include: 1) beginning treatment as young as possible; 2) focusing on the family, with the parent being the primary change agent for treatment; 3) using behavior modification techniques to change eating and activity behaviors; and 4) making 2 or 3 very specific changes in diet and activity at one time. Thus, the aim of this R21 application is to develop, implement, and evaluate a 6-month behavioral childhood obesity intervention that meets the Committee's recommendations and can be implemented in a primary care setting. A second aim of this project is to determine which eating and activity behaviors should be targeted in the intervention. One hundred thirty-five children, aged 4 to 9 years with a BMI \> 85th percentile, assessed and referred by their pediatricians, will be randomized to one of three conditions: 1) a newsletter condition; 2) a Behavioral Parenting Program that increases physical activity (60 min/day) and decreases sweetened drink consumption (\< 3 servings/week) (Traditional); or 3) a Behavioral Parenting Program that reduces TV watching (\< 2 hours/day) and increases low-fat milk consumption (2 servings/day) (Substitutes). Follow-up assessments on weight, height, and standardized BMI (z-BMI), the primary dependent variable, will be conducted at 3, 6, 9, and 12 months. Pediatricians will provide follow-up letters to families, regarding weight and height status, following the assessments. This pilot study allows us to determine the feasibility and efficacy of a pediatric obesity intervention that optimizes the role of the pediatrician and meets the Committee's recommendations for treatment in a primary care setting. Moreover, by comparing the effects of targeting the traditional or substitute behaviors, data will be obtained for a power analysis for a full-scale trial of the effects of these two approaches on long-term weight loss.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• Z-BMI in children

  12 months

Secondary Outcomes (1)

• Eating and activity behaviors

  12 months

Study Arms (3)

1

EXPERIMENTAL

Diet and Activity

Behavioral: Diet and Activity

2

EXPERIMENTAL

Diet and Activity

Behavioral: Diet and Activity

3

PLACEBO COMPARATOR

Education

Behavioral: Diet and Activity

Interventions

Diet and Activity BEHAVIORAL

Diet and Activity

1; 2; 3

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \) Age between 4 and 9 years. We propose to use this age group since parents are in control of the eating and exercise choices of such children, and thus a program that focuses on parenting behaviors (i.e., positive reinforcement, stimulus control, parental modeling) should be developmentally appropriate. This age group also meets the Expert Committee's goal of intervening early5; moreover children aged 4 to 8 years have similar nutritional needs.
• \) Body mass index (BMI) \> 85th percentile BMI. Based upon the Expert Committee recommendations,5 children \> 2 years of age who are identified as being at risk for overweight (85th to 94th percentile BMI) or overweight (\> 95th percentile BMI) should focus on weight maintenance as height continues to increase. These recommendations are aimed at reducing z-BMI.
• \) Tanner stage 1 (prepubertal) sexual maturation status. 4) Self-report at least one of the following problematic behaviors:
• Consume \> 1 serving of sweetened drink per day.
• Consume \< 2 servings of low-fat milk per day.
• Watch \> 2 hours of TV per day.
• Engage in physical activity that makes them sweat or breath hard \< 5 days per week.
• These behaviors have been selected because each has been associated with childhood obesity.
• \) A parent willing to attend treatment meetings. 6) Parent and child speak English.

You may not qualify if:

• Participants will be excluded if they:
• Report a family member participating in another weight loss program.
• Report that the child or parent planning to attend the treatment meetings has a major psychiatric disease or organic brain syndrome.
• Report that the child or parent planning to attend the treatment meetings has dietary or physical activity restrictions.
• Intend to move outside of the metropolitan area within the time frame of the investigation.

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institutes of Health (NIH): collaborator
• University of Tennessee: collaborator

Study Sites (1)

The Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

• Hart CN, Raynor HA, Osterholt KM, Jelalian E, Wing RR. Eating and activity habits of overweight children on weekdays and weekends. Int J Pediatr Obes. 2011 Oct;6(5-6):467-72. doi: 10.3109/17477166.2011.590204. Epub 2011 Jul 20.

  PMID: 21774578 DERIVED

• Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Evaluation of active and passive recruitment methods used in randomized controlled trials targeting pediatric obesity. Int J Pediatr Obes. 2009;4(4):224-32. doi: 10.3109/17477160802596189.

  PMID: 19922036 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hollie A Raynor

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: November 29, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 20, 2012

Record last verified: 2007-12

Locations

US (1)