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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL085400 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| American Academy of Pediatrics | OTHER |
| Academy of Nutrition and Dietetics | OTHER |
| University of Iowa |
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BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children. Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three groups. The first group continued with standard care; in group 2, each practitioner delivered four study Motivational Interviewing visits with the parent/caregiver, and in group 3 in addition to the practitioner, a registered dietitian delivered 6 Motivational Interviewing visits. The primary outcome will be the child's percentile BMI change between the baseline and 2-year follow-up. Secondary outcomes will include behavior change around fruits and vegetables, sweetened beverages and exercise. Our hypothesis is that there will be a larger decrease in BMI percentile for children in group 3 than in group 2, and that children in group 2 will have a decrease in BMI percentile when compared to group one.
The study is a cluster-randomized intervention trial with clinical practices serving as the unit of randomization and analysis. The investigators are testing two increasingly intensive interventions compared to a minimal intensity/Usual Care Group. Group 1 (Usual Care) includes determination of BMI percentile at baseline, 1-year, and 2-year follow-up. Usual Care (UC) practitioners provide parents with educational materials and routine care. UC pediatricians and their study staff received a ½ day study orientation session which included a brief CME-type workshop addressing obesity treatment.. Group 2 (Pediatric Practitioner only) includes the same assessment points as UC. In addition, Group 2 Pediatric Practitioners (PPs) received 2 days of in-person training in Motivational Interviewing (MI) and Behavior Therapy (BT) as well as an interactive DVD MI booster training system focusing on pediatric obesity. PPs in Group 2 are asked to schedule 3 proactive counseling sessions with a parent of the index child in Year 1 and one additional "booster" visit in year 2. To guide their counseling they are provided with a food and activity screening tool. In addition, Group 2 practices are provided with educational materials written in a style consistent with Motivational Interviewing and Self Determination Theory. Unlike in Group 1, where all of the educational materials are provided proactively to each parent, in Groups 2 and 3, materials are distributed on a more selective tailored basis depending on parent needs. Group 3 (PP+RD) includes the same intervention components as Group 2, but adds MI-based counseling from a trained and registered dietitian (RD) who is linked to that practice. RDs deliver 6 MI-based counseling sessions over 2 years. The intervention is front loaded with 4 sessions in Year 1 and the remaining 2 in Year 2. The RD sessions are delivered both in-person (required for visit 1) and optionally by telephone or in-person, subsequently. Similar to MDs, RDs received 2.0 days of in-person MI and BT training, and the interactive DVD MI booster training system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care with Education Materials | Active Comparator | Measure height and weight only. usual care |
|
| Moderate Dose Motivational Interviewing | Experimental | MI delivered by PCP, 4 sessions |
|
| Higher Dose Motivational Interviewing | Experimental | MI delivered by PCP, 4 sessions plus MI delivered by RD, 6 sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Behavioral | Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Child BMI Percentile | 2 years after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Fruit/Vegetable Consumption | 2 years after enrollment | |
| Sweetened Beverage Consumption | 2 years after enrollment | |
| Change in Physical Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Resnicow, PhD | University of Michigan | Principal Investigator |
| Richard Wasserman, MD, MPH | University of Vermont, American Academy of Pediatrics | Principal Investigator |
| Erica Slora, PhD | American Academy of Pediatrics | Principal Investigator |
| Linda G Snetselaar, PhD | University of Iowa | Principal Investigator |
| Esther Myers, PhD | Academy of Nutrition and Dietetics | Principal Investigator |
| Fiona McMaster, MA, MPH | University of Michigan | Study Director |
| Alison Bocian, MSc | American Academy of Pediatrics | Study Director |
| Donna Harris, MA | American Academy of Pediatrics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Research in Office Settings | Elk Grove Village | Illinois | 60007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36321279 | Derived | Woolford SJ, Resnicow K, Davis MM, Nichols LP, Wasserman RC, Harris D, Gebremariam A, Shone L, Fiks AG, Chang T. Cost-effectiveness of a motivational interviewing obesity intervention versus usual care in pediatric primary care offices. Obesity (Silver Spring). 2022 Nov;30(11):2265-2274. doi: 10.1002/oby.23560. | |
| 27261549 | Derived | Resnicow K, Harris D, Wasserman R, Schwartz RP, Perez-Rosas V, Mihalcea R, Snetselaar L. Advances in Motivational Interviewing for Pediatric Obesity: Results of the Brief Motivational Interviewing to Reduce Body Mass Index Trial and Future Directions. Pediatr Clin North Am. 2016 Jun;63(3):539-62. doi: 10.1016/j.pcl.2016.02.008. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care With Education Materials | Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment |
| FG001 | Moderate Dose Motivational Interviewing | Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment |
| FG002 | Higher Dose Motivational Interviewing | Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care With Education Materials | Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment |
| BG001 | Moderate Dose Motivational Interviewing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Child BMI Percentile | Posted | Mean | Standard Error | BMI Percentile | 2 years after recruitment |
|
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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 | Standard Care With Education Materials | Standard Care: Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ken Resnicow | University of Michigan | 734 647 0212 | kresnic@umich.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
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| Moderate Dose Motivational Interviewing | Behavioral | Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment |
|
| Higher Dose Motivational Interviewing | Behavioral | Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment |
|
| 2 years after enrollment |
| 25825539 | Derived | Resnicow K, McMaster F, Bocian A, Harris D, Zhou Y, Snetselaar L, Schwartz R, Myers E, Gotlieb J, Foster J, Hollinger D, Smith K, Woolford S, Mueller D, Wasserman RC. Motivational interviewing and dietary counseling for obesity in primary care: an RCT. Pediatrics. 2015 Apr;135(4):649-57. doi: 10.1542/peds.2014-1880. |
| 22434735 | Derived | Resnicow K, McMaster F, Woolford S, Slora E, Bocian A, Harris D, Drehmer J, Wasserman R, Schwartz R, Myers E, Foster J, Snetselaar L, Hollinger D, Smith K. Study design and baseline description of the BMI2 trial: reducing paediatric obesity in primary care practices. Pediatr Obes. 2012 Feb;7(1):3-15. doi: 10.1111/j.2047-6310.2011.00001.x. Epub 2011 Dec 13. |
Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment |
| BG002 | Higher Dose Motivational Interviewing | Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Higher Dose Motivational Interviewing | Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment |
|
|
| Secondary | Fruit/Vegetable Consumption | Posted | Mean | Standard Error | Post test adjuste, servings per day | 2 years after enrollment |
|
|
|
| Secondary | Sweetened Beverage Consumption | Posted | Mean | Standard Error | Adjusted posted test servings per day | 2 years after enrollment |
|
|
|
| Secondary | Change in Physical Activity | Posted | Mean | Standard Error | Adjusted posttest hours per day | 2 years after enrollment |
|
|
|
| 0 |
| 198 |
| 0 |
| 198 |
| EG001 | Moderate Dose Motivational Interviewing | Moderate Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment | 0 | 212 | 0 | 212 |
| EG002 | Higher Dose Motivational Interviewing | Higher Dose Motivational Interviewing: Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment | 0 | 235 | 0 | 235 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |