Clinical trial NCT01146314: A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
Official title: A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Type 2 Diabetes
Metabolic Syndrome
Keywords: family-focused intervention
pediatric obesity
diabetes prevention
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2010-06-17
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement of health status of overweight children
timeFrame: Measured at 6 and 12 months
Secondary outcomes:
measure: Improvement of health behaviors and psychosocial adjustment
timeFrame: Measured at 6 and 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Amanda S Lochrie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.