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

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ClinicalTrials.gov Identifier: NCT01146314
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : May 1, 2013
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Amanda Lochrie, Nemours Children's Clinic

Tracking Information
First Submitted Date  ICMJE June 16, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date May 1, 2013
Study Start Date  ICMJE September 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01146314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
Official Title  ICMJE A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pediatric Obesity
  • Type 2 Diabetes
  • Metabolic Syndrome
Intervention  ICMJE 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.
Study Arms 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.
Intervention: Behavioral: Family Focused Lifestyle Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2010)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date March 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 11 Years   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01146314
Other Study ID Numbers  ICMJE 18-06038-001
1-06-JF-33 ( Other Grant/Funding Number: American Diabetes Association )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Amanda Lochrie, Nemours Children's Clinic
Study Sponsor  ICMJE Nemours Children's Clinic
Collaborators  ICMJE American Diabetes Association
Investigators  ICMJE
Principal Investigator: Amanda S Lochrie, PhD Nemours Children's Clinic
PRS Account Nemours Children's Clinic
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP