Treatment of Early Childhood Overweight in Primary Care: Pilot Study

NCT01662557 | Completed

• 2 other identifiers: 807610R34DK080473
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Child's Overweight Percentage

  Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)

  Baseline and Month 5

• Body Mass Index z-score (BMI-z)

  Change in BMI-z score will be measured from baseline to end of treatment (month 5)

  Baseline and Month 5

• Waist Circumference

  Change in child's waist circumference will be measured from baseline to end of treatment (month 5).

  Baseline and Month 5

• Body Mass Index (BMI)

  Change in BMI will be measured from baseline to end of treatment (month 5).

  Baseline and Month 5

Secondary Outcomes (7)

• Dietary Intake

  Baseline and Month 5

• Activity Level

  Baseline to Month 5

• Insulin (uUnits/ml)

  Baseline and Month 5

• Glucose (mg/dl)

  Baseline and Month 5

• Triglycerides (mg/dl)

  Baseline and Month 5

Study Arms (2)

Family Behavior Modification

ACTIVE COMPARATOR

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

Behavioral: Family Behavior Modification

Minimal Nutrition Information

OTHER

Weekly mailings emphasizing healthy eating guidelines for families.

Other: Minimal Nutrition Information

Interventions

Family Behavior Modification 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.

Also known as: FBM

Family Behavior Modification

Minimal Nutrition Information 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.

Also known as: MNI

Minimal Nutrition Information

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Geisinger Center for Health Research: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pennsylvania Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Myles S Faith, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 10, 2012
• Study Start: February 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 15, 2012

Record last verified: 2011-01

Locations

US (1)