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OpenTrials
Completed

NCT Number: NCT02502383

ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity

Using a previously created weight management program for adolescents, the intervention will be implemented through school-based health centers (SBHC) and will be delivered by SBHC providers trained in Motivational Interviewing. Students at intervention school sites will be compared to students at control school sites. All students will have baseline, 1 year, and 2 year follow-up to assess if students in the intervention school sites will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students at control school sites.

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Key information

Conditions

Overweight Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta S Kong, MD, MPH

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • enrolled in 9th or 10th grade at participating schools

Exclusion criteria

  • blood pressure in the range of stage 2 hypertension
  • previously diagnosed type 1 or type 2 diabetes
  • use of corticosteroids, antipsychotics, metformin, antihypertensive medications, and medications used for dyslipidemia
  • inability to perform moderate to vigorous physical activity
  • not ambulatory
  • a score of 20 or more on Eating Attitudes Test (EAT)-26 screening measure
  • developmental disorders that affect weight or ability to understand the study procedures or counseling

Treatment and study plan

ACTION PAC

Behavioral

School-based health center providers will use motivational interviewing to assist students with adopting strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI and other health results discussion with clinical providers. Adolescents with overweight/obesity will meet with providers for 16 sessions over 2 years.

Communication with parents

Behavioral

A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians.

Primary outcomes

  1. Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study

    Time frame: Baseline to two years

    Number and percentage of students who had a baseline BMI <85th percentile who had a BMI>= 85th percentile (overweight or obese) at endline

  2. Change in Physical Activity

    Time frame: Baseline to two years

    Change in minutes of moderate-to-vigorous physical activity as measured by accelerometer for participants who had a baseline BMI <85th percentile and endline data

  3. Change in Reported Added Sugar Intake

    Time frame: Baseline to two years

    Reported change in added sugar intake as measured by the Block Kids Food Screener-Last Week for Ages 2-17 for students who had a baseline BMI <85th percentile and endline data

  4. Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes)

    Time frame: Baseline to two years

    Change in reported fruit, vegetables, and legume intake (not including potatoes) for students who had a baseline BMI <85th percentile and endline data

  5. Change in BMI Z-score

    Time frame: Baseline to two years

    Change in body-mass index (BMI; weight in kilograms divided by the square of the body height in meters) Z-score for students who had a baseline BMI >= 85th percentile (overweight or obese) and endline data. A Z-score of 0 represents the population mean. A Z-score above 2 indicates obesity (BMI >2 standard deviations above the mean) in children and teens. A decline in BMI Z-score would be a positive outcome in this weight management study.

  6. Change in HOMA-IR

    Time frame: Baseline to two years

    Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR; insulin resistance index) for students who had a baseline BMI >= 85th percentile (overweight or obese) and endline data. HOMA-IR is calculated using the formula: (fasting glucose [mg/dL] x fasting insulin [microU/mL])/405. HOMA-IR values >2 indicate insulin resistance. A decrease in HOMA-IR would be a positive outcome.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Acronym: ACTION PAC

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2015
Registry last updated
Jun 26, 2024

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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