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

April 30, 2013 updated by: Amanda Lochrie, Nemours Children's Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle intervention
A 6-month 14 session lifestyle intervention led by a psychologist and a dietitian for 90 minutes group sessions. Intervention sessions were help weekly, biweekly, and monthly over the course of 6 months.
Behavioral: Family Focused Lifestyle Intervention
The lifestyle intervention is a 6-month intervention study lasting 6 months. The intervention is 14 sessions and conducted by a dietician and psychologist in a group setting with each intervention session lasting 90 minutes. The sessions are conducted weekly, biweekly, and monthly over the course of 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of health behaviors and psychosocial adjustment
Time Frame: Measured at 6 and 12 months
Evaluated the effects of the intervention on changing health behaviors, such as eating patterns, diet, and eating behavior, and evaluate the effects of maintaining of improving adjustment to psychological stressors associated with being overweight (self esteem, depression, behavior).
Measured at 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Amanda S Lochrie, PhD, Nemours Children's Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-06038-001
  • 1-06-JF-33 (Other Grant/Funding Number: American Diabetes Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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