Childhood Obesity
Conditions
Keywords
Pediatric Obesity, Motivational Interviewing, Overweight, Behavior Change
Brief summary
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.
Detailed description
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.
Interventions
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
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
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
Sponsors
Study design
Eligibility
Inclusion criteria
* 85th - 97th percentile BMI * parent/care giver ability to converse in English * working telephone
Exclusion criteria
* child under current subspecialty care for overweight/obesity * child currently taking weight-altering medication (at enrollment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child BMI Percentile | 2 years after recruitment |
Secondary
| Measure | Time frame |
|---|---|
| Fruit/Vegetable Consumption | 2 years after enrollment |
| Sweetened Beverage Consumption | 2 years after enrollment |
| Change in Physical Activity | 2 years after enrollment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 198 |
| 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 | 212 |
| 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 | 235 |
| Total | 645 |
Baseline characteristics
| Characteristic | Standard Care With Education Materials | Moderate Dose Motivational Interviewing | Higher Dose Motivational Interviewing | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 198 Participants | 212 Participants | 235 Participants | 645 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.7 YEARS STANDARD_DEVIATION 1.7 | 5.1 YEARS STANDARD_DEVIATION 1.9 | 5.3 YEARS STANDARD_DEVIATION 1.8 | 5.1 YEARS STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 64 Participants | 49 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 152 Participants | 139 Participants | 180 Participants | 471 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 9 Participants | 6 Participants | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 3 Participants | 21 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 23 Participants | 14 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 8 Participants | 12 Participants | 39 Participants |
| Race (NIH/OMB) White | 160 Participants | 178 Participants | 188 Participants | 526 Participants |
| Region of Enrollment United States | 198 participants | 212 participants | 235 participants | 645 participants |
| Sex: Female, Male Female | 105 Participants | 121 Participants | 141 Participants | 367 Participants |
| Sex: Female, Male Male | 93 Participants | 91 Participants | 94 Participants | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 198 | 0 / 212 | 0 / 235 |
| serious Total, serious adverse events | 0 / 198 | 0 / 212 | 0 / 235 |
Outcome results
Child BMI Percentile
Time frame: 2 years after recruitment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care With Education Materials | Child BMI Percentile | 90.31 BMI Percentile | Standard Error 0.94 |
| Moderate Dose Motivational Interviewing | Child BMI Percentile | 88.1 BMI Percentile | Standard Error 0.94 |
| Higher Dose Motivational Interviewing | Child BMI Percentile | 87.1 BMI Percentile | Standard Error 0.92 |
Change in Physical Activity
Time frame: 2 years after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care With Education Materials | Change in Physical Activity | 2.1 Adjusted posttest hours per day | Standard Error 0.05 |
| Moderate Dose Motivational Interviewing | Change in Physical Activity | 1.9 Adjusted posttest hours per day | Standard Error 0.06 |
| Higher Dose Motivational Interviewing | Change in Physical Activity | 2.1 Adjusted posttest hours per day | Standard Error 0.06 |
Fruit/Vegetable Consumption
Time frame: 2 years after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care With Education Materials | Fruit/Vegetable Consumption | 3.8 Post test adjuste, servings per day | Standard Error 0.12 |
| Moderate Dose Motivational Interviewing | Fruit/Vegetable Consumption | 4.1 Post test adjuste, servings per day | Standard Error 0.14 |
| Higher Dose Motivational Interviewing | Fruit/Vegetable Consumption | 4.3 Post test adjuste, servings per day | Standard Error 0.13 |
Sweetened Beverage Consumption
Time frame: 2 years after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care With Education Materials | Sweetened Beverage Consumption | 1.3 Adjusted posted test servings per day | Standard Error 0.11 |
| Moderate Dose Motivational Interviewing | Sweetened Beverage Consumption | 1.3 Adjusted posted test servings per day | Standard Error 0.11 |
| Higher Dose Motivational Interviewing | Sweetened Beverage Consumption | 1.0 Adjusted posted test servings per day | Standard Error 0.12 |