NCT00863083

Brief Summary

The purpose of the study is to examine the extent to which two different reward systems implemented in the context of a multi-family pediatric weight management group differentially promote adoption of healthy eating and activity habits among overweight and obese 8-17 year old youth. Participants will be randomly assigned to one of two reward conditions: rewards for attendance only or rewards for attendance and goal attainment. We hypothesize that all participants will demonstrate significant increases in healthy nutritional choices and physical activity and significant reductions in sedentary activity from pre-intervention to post intervention. We expect that participants in attendance plus goal attainment reward condition will demonstrate significantly greater improvements than participants in the attendance only condition.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

5 months

First QC Date

March 16, 2009

Last Update Submit

June 17, 2010

Conditions

Keywords

pediatric obesitypediatric overweightmulti-family group weight management interventionfinancial rewards

Outcome Measures

Primary Outcomes (2)

  • dietary habits

    pre, post, quarterly follow ups

  • physical and sedentary activity

    pre, post, quarterly follow ups

Secondary Outcomes (2)

  • body mass index

    pre, post, quarterly follow ups

  • participant satisfaction

    post intevention

Study Arms (2)

1

ACTIVE COMPARATOR

Multifamily group weight management intervention plus rewards for program attendance

Behavioral: Multifamily weight management intervention

2

ACTIVE COMPARATOR

Multifamily group weight management intervention plus rewards for attendance and goal attainment

Behavioral: Multifamily weight management intervention

Interventions

8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines.

12

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patient age 8-17 years
  • patient with public insurance managed by Children's Community Health Network
  • English speaking patient and parent
  • patient body mass index at or above the 85th percentile for age and sex
  • parent or legal guardian willing to participate

You may not qualify if:

  • significant patient developmental or cognitive delay
  • concurrent involvement in another formal weight management program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin/Children's Hosptial of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rachel Neff Greenley, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations