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
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obesity Type 2 Diabetes Metabolic Syndrome||Behavioral: Family Focused Lifestyle Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||March 2010|
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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146314
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32207|
|Principal Investigator:||Amanda S Lochrie, PhD||Nemours Children's Clinic|