A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
NCT ID: NCT01146314
Last Updated: 2013-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2006-09-30
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age between 8-11 years old
Exclusion Criteria
* Diagnosis of type 2 diabetes
* Diagnosis of Mental Retardation
8 Years
11 Years
ALL
No
Sponsors
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American Diabetes Association
OTHER
Nemours Children's Clinic
OTHER
Responsible Party
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Amanda Lochrie
Principal Investigator
Principal Investigators
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Amanda S Lochrie, PhD
Role: PRINCIPAL_INVESTIGATOR
Nemours Children's Clinic
Locations
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Nemours Children's Clinic
Jacksonville, Florida, United States
Countries
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References
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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.
Other Identifiers
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1-06-JF-33
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
18-06038-001
Identifier Type: -
Identifier Source: org_study_id
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