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Completed

NCT Number: NCT02029976

School Nurse-directed Secondary Obesity Prevention for Elementary School Children

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Amherst, Amherst, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

attention control condition after school weight management program

Mailed monthly newsletters

Behavioral

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Primary outcomes

  1. Child Body Mass Index (BMI)

    Time frame: Measurement data will be collected at baseline prior to randomization and 12 (YR-1 post intervention), and 24 (YR-2 follow up) months post randomization

    Body Mass Index (primary outcome) is the recommended method of assessing overweight among children and was calculated with the formula: weight (kg)/height (m) 2. To determine child BMI percentile, we calculated age- and gender-adjusted BMI with Centers for Disease Control and Prevention (CDC) growth charts.. The primary outcome measure is BMI Z-Score, which indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A higher Z-score is a less favorable outcome when assessing overweight/obesity across conditions in a healthy weight management intervention..

Secondary outcomes

  1. Dietary: Healthy Eating Index

    Time frame: The measure was collected at 12 months (YR-1 post intervention) following randomization with result adjusted for baseline value, percent body fat, sex and economic assistance

    The Healthy Eating Index-2015 (HEI-2015) will be assessed with multiple 24-hour dietary recall interviews. A score on the HEI-2015 ranges from 0 to 100, with 100 meeting the recommendations for all 13 components of the HEI-2015. The higher the score the better.

  2. Activity

    Time frame: The measure was collected at 12 months (YR-1 post intervention), following randomization with result adjusted for baseline value, percent body fat, sex and age

    Activity will be assessed with the MTI ActiGraph uniaxial accelerometer worn for a 7-day period. Time spent in each category of sedentary or moderate-vigorous physical activity was calculated as a percent of total wear time, with higher numbers indicating more time spent in the category.

  3. Total Quality of Life

    Time frame: Measurement data will be collected at baseline prior to randomization and 12 (YR-1 post intervention) , and 24 (YR-2 follow up) months following randomization

    The 23-item Pediatric Quality of Life (QOL) child inventory or PedsQL 4.0 was used to assess physical, emotional, social and school functioning. Responses are reversed scored and transformed to a 0 to 100 scale which is used to calculate a total health-related quality of life summary score (mean of 23 items) which includes a physical health summary score (mean of 8 physical functioning items) and psycho-social health summary score (mean of 15 emotional, social and school functioning items). A higher score indicates better child-reported health-related quality of life.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2014
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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