FITLINE: Pediatric Practice-based Obesity Intervention to Support Families

University of Massachusetts, Worcester

Status: Completed

Conditions: Obesity, Childhood

Treatments: Behavioral: Coaching; Behavioral: Materials

Study type: Interventional

Funder types: Other

Identifiers

NCT03143660

R01HL130505

Details and patient eligibility

About

The goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.

Full description

The proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and twelve parents and their children ages 8-12 with a body mass index (BMI) of > 85th percentile (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month follow-up.

Enrollment: 501 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. child BMI >= 85th percentile for age/sex,
2. participating parent and child English speaking,
3. parent has access to a telephone and is available to participate in telephone counseling sessions, and
4. referred by the child's primary care provider.

Exclusion criteria

1. planning to move out of the area during the period of study participation,
2. medical condition that precludes adherence to AAP dietary and physical activity recommendations,
3. genetic or endocrine causes of obesity,
4. prescribed medications associated with weight gain,
5. child on psychiatric medications, and/or
6. morbidly obese (> 300 pounds). -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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501 participants in 2 patient groups

Coaching

Active Comparator group

Description:

A parent support component consisting of eight weekly telephone counseling calls by centrally located nutritionists to provide parents coaching tailored to their family's unique needs to help them set goals and make targeted lifestyle changes recommended by the American Academy of Pediatrics (AAP) for Stage 1, Prevention Plus, accompanied by a parent booklet

Treatment:

Behavioral: Coaching

Materials

Active Comparator group

Description:

Parents will receive the same educational materials provided in the Fitline family workbook mailed over 8 weeks to control for weekly contact and educational curriculum, but no Fitline counseling.

Treatment:

Behavioral: Materials