Treatment of Early Childhood Overweight in Primary Care: Pilot Study

NCT ID: NCT01662557

Last Updated: 2012-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-03-31

Brief Summary

Childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. The primary care setting provides an attractive option for families wishing to receive treatment, yet little is known about the feasibility, acceptance or efficacy of this intervention setting. The purpose of this study was to test two different primary care treatments that were intended to increase fruit and vegetable intake, increase physical activity, and reduce sedentary activity in children ages 4-8, who are overweight or at risk for becoming overweight. Both treatments involved the child and a parent/caregiver and both were conducted over a four month period. The parent/child dyads were selected from the pool of families who receive their primary care within the Geisinger Medical Center geographic area and who have been identified by their pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile for age). One group received weekly mailings which focused on healthy eating, promotion of fruit and vegetable intake and physical activity, and methods to reduce TV viewing time. The second group received a group-based intervention at one of the Geisinger Pediatric Clinic sites using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as treatment satisfaction and acceptance. The investigators hypothesized that children who receive Family Behavior Modification (FBM) in the primary care setting will show greater reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference, and that children receiving FBM will show greater improvements in dietary intake, increased physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.

Conditions

Obesity

Keywords

Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Family Behavior Modification

Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities.

Group Type: ACTIVE_COMPARATOR

Family Behavior Modification

Intervention Type: BEHAVIORAL

5-month intervention for parents and children providing 15 sessions in behavioral skills training in self monitoring, Traffic Light Diet, goal setting, reinforcement and tasting sessions. Of the 15 sessions, 3 were structured as phone sessions.

Minimal Nutrition Information

Weekly mailings emphasizing healthy eating guidelines for families.

Group Type: OTHER

Minimal Nutrition Information

Intervention Type: OTHER

Families assigned to MNI received a series of 15 mailings on topics related identifying a healthy body weight for children; energy balance and calorie requirements for children; MyPyramid for Kids; portion control; the benefits of physical activity and screen-time reduction; encouraging fruit and vegetable consumption; healthy snacks and smart shopping; and encouraging family meals.

Interventions

Family Behavior Modification

5-month intervention for parents and children providing 15 sessions in behavioral skills training in self monitoring, Traffic Light Diet, goal setting, reinforcement and tasting sessions. Of the 15 sessions, 3 were structured as phone sessions.

Intervention Type: BEHAVIORAL

Minimal Nutrition Information

Families assigned to MNI received a series of 15 mailings on topics related identifying a healthy body weight for children; energy balance and calorie requirements for children; MyPyramid for Kids; portion control; the benefits of physical activity and screen-time reduction; encouraging fruit and vegetable consumption; healthy snacks and smart shopping; and encouraging family meals.

Intervention Type: OTHER

Other Intervention Names

FBM; MNI

Eligibility Criteria

Inclusion Criteria

• 4-8 year old children
• overweight or obese (BMI≥85th percentile, based on age and sex)
• Parent/primary caregiver willing to attend sessions with child

Exclusion Criteria

• Failure to meet BMI criteria
• Child with elevated internalizing or externalizing behavioral problems, as assessed through Child Behavior Checklist (CBCL)
• Elevated parent distress, as measured by Symptom Checklist-90 (SCL-90)
• Child on medications with any weight-altering effect
• Inability to participate in moderate physical activity or attend study visits
• Residing >1 hour from study site

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geisinger Center for Health Research

UNKNOWN

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myles S Faith, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R34DK080473

Identifier Type: NIH

Identifier Source: secondary_id

View Link

807610

Identifier Type: -

Identifier Source: org_study_id