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

Nemours Children's Health

Status: Completed

Conditions: Type 2 Diabetes; Pediatric Obesity; Metabolic Syndrome

Treatments: Behavioral: Family Focused Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01146314

18-06038-001

1-06-JF-33 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 8 to 11 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Lifestyle intervention

Experimental group

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.

Treatment:

Behavioral: Family Focused Lifestyle Intervention