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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTION PAC Behavioral Intervention | Experimental | Students attending intervention schools will receive the ACTION PAC intervention and communication of BMI and other health results to parents via a letter. |
|
| Comparison | Active Comparator | Students attending comparison schools will receive communication of BMI and other health results to parents via a letter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study | Number and percentage of students who had a baseline BMI <85th percentile who had a BMI>= 85th percentile (overweight or obese) at endline | Baseline to two years |
| Change in Physical Activity | 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 | Baseline to two years |
| Change in Reported Added Sugar Intake | 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 | Baseline to two years |
| Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes) | Change in reported fruit, vegetables, and legume intake (not including potatoes) for students who had a baseline BMI <85th percentile and endline data | Baseline to two years |
| Change in BMI Z-score | 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. | Baseline to two years |
| Change in HOMA-IR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberta Kong, MD, MPH | UNM Health Sciences Center/Dept of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta S Kong, MD, MPH | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28793946 | Background | Vallabhan MK, Kong AS, Jimenez EY, Summers LC, DeBlieck CJ, Feldstein Ewing SW. Training Primary Care Providers in the Use of Motivational Interviewing for Youth Behavior Change. Res Theory Nurs Pract. 2017 Aug 1;31(3):219-232. doi: 10.1891/1541-6577.31.3.219. | |
| 30348753 | Background | Vallabhan MK, Jimenez EY, Nash JL, Gonzales-Pacheco D, Coakley KE, Noe SR, DeBlieck CJ, Summers LC, Feldstein-Ewing SW, Kong AS. Motivational Interviewing to Treat Adolescents With Obesity: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20180733. doi: 10.1542/peds.2018-0733. Epub 2018 Oct 22. |
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Teens were excluded based on assessments at the baseline visit: blood pressure in the range of stage 2 hypertension or a score of ≥20 on the Eating Attitudes Test.
Participants were enrolled from February 2014 to November 2015. Participants were recruited during general school registration events, the classes or practices of interested teachers, and lunch time.
| ID | Title | Description |
|---|---|---|
| FG000 | ACTION PAC | 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. A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians. |
| FG001 | Comparison | A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACTION PAC | 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. A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study | Number and percentage of students who had a baseline BMI <85th percentile who had a BMI>= 85th percentile (overweight or obese) at endline | Students that had a baseline BMI <85th percentile and who had endline data | Posted | Count of Participants | Participants | Baseline to two years |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACTION PAC | ACTION PAC: Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberta Kong | University of New Mexico Health Sciences | 505-272-5551 | AKong@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2016 | Mar 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Communication with parents | Behavioral | A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians. |
|
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.
| Baseline to two years |
| 30605423 | Background | Euler R, Jimenez EY, Sanders S, Kuhlemeier A, Van Horn ML, Cohen D, Gonzales-Pacheco D, Kong AS. Rural-Urban Differences in Baseline Dietary Intake and Physical Activity Levels of Adolescents. Prev Chronic Dis. 2019 Jan 3;16:E01. doi: 10.5888/pcd16.180200. |
| 31310994 | Background | Sanders SG, Jimenez EY, Cole NH, Kuhlemeier A, McCauley GL, Van Horn ML, Kong AS. Estimated Physical Activity in Adolescents by Wrist-Worn GENEActiv Accelerometers. J Phys Act Health. 2019 Sep 1;16(9):792-798. doi: 10.1123/jpah.2018-0344. Epub 2019 Jul 17. |
| 35032253 | Background | Kuhlemeier A, Jaki T, Jimenez EY, Kong AS, Gill H, Chang C, Resnicow K, Wilson DK, Van Horn ML. Individual differences in the effects of the ACTION-PAC intervention: an application of personalized medicine in the prevention and treatment of obesity. J Behav Med. 2022 Apr;45(2):211-226. doi: 10.1007/s10865-021-00274-2. Epub 2022 Jan 15. |
| 36643597 | Background | Hess JM, Jimenez EY, Ozechowski TJ, McCauley G, Sanders SG, Sedillo D, Vallabhan MK, Kong AS. Teen and caregiver perspectives on success, clinician role, and family involvement in ACTION PAC, a weight management intervention trial. PEC Innov. 2022 Dec;1:100060. doi: 10.1016/j.pecinn.2022.100060. Epub 2022 Jun 24. |
| BG001 | Comparison | A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Yearly household income | Count of Participants | Participants |
|
| OG001 | Comparison | Comparison: Annual BMI results will not be discussed with participants in comparison schools; however, a letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians. |
|
|
| Primary | Change in Physical Activity | 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 | Posted | Mean | Standard Deviation | minutes | Baseline to two years |
|
|
|
| Primary | Change in Reported Added Sugar Intake | 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 | Posted | Mean | Standard Deviation | teaspoons | Baseline to two years |
|
|
|
| Primary | Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes) | Change in reported fruit, vegetables, and legume intake (not including potatoes) for students who had a baseline BMI <85th percentile and endline data | Posted | Mean | Standard Deviation | cups | Baseline to two years |
|
|
|
| Primary | Change in BMI Z-score | 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. | Posted | Mean | Standard Deviation | standard deviation units | Baseline to two years |
|
|
|
| Primary | Change in HOMA-IR | 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. | Posted | Mean | Standard Deviation | index score units | Baseline to two years |
|
|
|
| 0 |
| 504 |
| 0 |
| 504 |
| 19 |
| 504 |
| EG001 | Comparison | Comparison: Annual BMI results will not be discussed with participants in comparison schools; however, a letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians. | 0 | 487 | 0 | 487 | 15 | 487 |
| Met criteria for eating disorder (anorexia, bulimia) | Psychiatric disorders | Systematic Assessment |
|
| Development of hypertension | Cardiac disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |