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

Primary Purpose

Pediatric Obesity, Type 2 Diabetes, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Focused Lifestyle Intervention
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring family-focused intervention, pediatric obesity, diabetes prevention

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nemours Children's Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement of health status of overweight children
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 Outcome Measures

Improvement of health behaviors and psychosocial adjustment
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).

Full Information

First Posted
June 16, 2010
Last Updated
April 30, 2013
Sponsor
Nemours Children's Clinic
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT01146314
Brief Title
A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
Acronym
FBI
Official Title
A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
American Diabetes Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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). 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). 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Type 2 Diabetes, Metabolic Syndrome
Keywords
family-focused intervention, pediatric obesity, diabetes prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Focused Lifestyle Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of health status of overweight children
Description
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.
Time Frame
Measured at 6 and 12 months
Secondary Outcome Measure Information:
Title
Improvement of health behaviors and psychosocial adjustment
Description
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).
Time Frame
Measured at 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda S Lochrie, PhD
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33650888
Citation
Kahhan N, Hossain MJ, Lang J, Harrison C, Canas J, Wysocki T, Lochrie A, Balagopal PB. Durability of Changes in Biomarkers of Cardiometabolic Disease: 1-Year Family-Based Intervention in Children with Obesity. Metab Syndr Relat Disord. 2021 Jun;19(5):264-271. doi: 10.1089/met.2020.0097. Epub 2021 Mar 1.
Results Reference
derived

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

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