School Nurse-directed Secondary Obesity Prevention for Elementary School Children

Temple University

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together); Behavioral: Mailed monthly newsletters

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02029976

1R01NR013473-01A1 (U.S. NIH Grant/Contract)

00029947

Details and patient eligibility

About

Primary Aim: To test the efficacy of an elementary school-based, school nurse-led weight management program to reduce excess weight gain among children, 8 to 12 years old who are overweight and at risk of overweight by increasing healthy dietary practices and physical activity levels and decreasing sedentary practices.

Primary Hypothesis: Relative to the control condition, the children receiving the intervention will have a significantly lower body mass index (BMI), following implementation of the 9-month intervention, controlling for baseline values.

Full description

Primary Hypothesis: Relative to the control condition, the children receiving the intervention will have a significantly lower body mass index (BMI), following implementation of the 9-month intervention, controlling for baseline values.

Enrollment: 264 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for child participants:

• 3rd 4th and 5th grade student the year the intervention is implemented,
• ≥ 8 and ≤ 12 years old,
• age- and gender-adjusted BMI ≥ 75th percentile,
• child must live in a primary residence with the participating parent

Exclusion Criteria for child participants:

• plans to move outside the school district within the next 12 months,
• food allergies,
• physical limitations,
• medical conditions that prohibit participation in the intervention program or measurement,
• does not speak and write in English.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

attention control condition

Active Comparator group

Description:

Child and parent participants randomized to the attention control condition will receive a Newsletter Program or mailed monthly newsletter with general family-focused health information.

Treatment:

Behavioral: Mailed monthly newsletters

after school weight management program

Experimental group

Description:

The 9-month after school weight management program called SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together), with a focus on healthy food and activity practices will be directed by a school nurse and will include: 1) quarterly parent/child coaching sessions with the school nurse held in the participant's home; 2) 14 child group sessions led by the school nurse, held in a school setting 1-2 times a month; 3) 5 parent group sessions led by a school nurse held in a school setting.

Treatment:

Behavioral: SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)