Trials / Completed
CompletedNCT01335308
Brief Motivational Interviewing to Reduce Child Body Mass Index
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 645 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 2 Years – 10 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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 |
| BEHAVIORAL | 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 |
| BEHAVIORAL | 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 |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2013-07-01
- Completion
- 2013-12-01
- First posted
- 2011-04-14
- Last updated
- 2023-10-13
- Results posted
- 2017-06-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01335308. Inclusion in this directory is not an endorsement.