Skip to main content
Clinical Trials/NCT01146314
NCT01146314
Completed
N/A

A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children

Nemours Children's Clinic1 site in 1 country150 target enrollmentSeptember 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
Nemours Children's Clinic
Enrollment
150
Locations
1
Primary Endpoint
Improvement of health status of overweight children
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study was to determine if a family-focused lifestyle intervention helps to improve the health status, behaviors, and adjustment of overweight children.

Detailed Description

Type 2 diabetes (DM2), and obesity is increasing dramatically in the United States and worldwide among children. Even before children are diagnosed with DM2, they often show signs such as being overweight, having high blood pressure, abnormal lipid metabolism, and impaired glucose tolerance that put them at risk for other diseases, such as heart disease. In addition, children who are at risk for DM2 also face elevated risks of other major medical complications along with psychological and social consequences (e.g., depression, teasing, discrimination, school problems), which can often be just as damaging as the medical problems. Since obesity plays an important role in the progression to DM2, the need to prevent children from progressing to a diagnosis of DM2 is critical. The proposed study was a randomized controlled trial comparing an education group for families of children at high risk for progression to metabolic syndrome and type 2 diabetes with a family-focused multi-component lifestyle intervention. The study addressed these specific aims: 1. Evaluated the effects of a family-focused lifestyle intervention on the health status of children at risk of metabolic syndrome (BMI, blood pressure, cholesterol, impaired glucose tolerance, waist circumference). 2. Evaluated the effects of a family focused psychosocial treatment on the health behaviors of children at risk for developing metabolic syndrome (eating behaviors, physical activity). 3. Evaluated the effects of a family focused psychosocial treatment on psychological outcomes of children at risk of developing metabolic syndrome (overall behavioral functioning, perception, self esteem, depression, quality of life). 4. Analyzed variables that are predictive of maintenance or termination of engagement in the family-focused lifestyle intervention. It was hypothesized that this intervention approach will result in: a) improved health status and a reduction of risk for developing metabolic syndrome (BMI, waist circumference, blood pressure, cholesterol, and glucose levels), b) improved health behaviors (physical activity, diet), and c) generalize to more optimal psychosocial functioning (depression, self-perception, quality of life, school attendance) at short and long-term follow-up of the children in the intervention group compared with children in the education group.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
March 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amanda Lochrie

Principal Investigator

Nemours Children's Clinic

Eligibility Criteria

Inclusion Criteria

  • BMI 85th percentile and above, otherwise healthy
  • Age between 8-11 years old

Exclusion Criteria

  • Diagnosis of metabolic syndrome
  • Diagnosis of type 2 diabetes
  • Diagnosis of Mental Retardation

Outcomes

Primary Outcomes

Improvement of health status of overweight children

Time Frame: Measured at 6 and 12 months

Evaluated the effects of the intervention on improving BMI, blood pressure, waist circumference, and reducing the risk of the development of type 2 diabetes and metabolic syndrome.

Secondary Outcomes

  • Improvement of health behaviors and psychosocial adjustment(Measured at 6 and 12 months)

Study Sites (1)

Loading locations...

Similar Trials