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Brief Motivational Interviewing to Reduce Child Body Mass Index

Brief Motivational Interviewing to Reduce Child Body Mass Index

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01335308
Acronym
BMi2
Enrollment
645
Registered
2011-04-14
Start date
2009-10-31
Completion date
2013-12-31
Last updated
2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

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

BEHAVIORALStandard 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

BEHAVIORALModerate 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

BEHAVIORALHigher 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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
American Academy of Pediatrics
CollaboratorOTHER
Academy of Nutrition and Dietetics
CollaboratorOTHER
University of Iowa
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes

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

MeasureTime frame
Child BMI Percentile2 years after recruitment

Secondary

MeasureTime frame
Fruit/Vegetable Consumption2 years after enrollment
Sweetened Beverage Consumption2 years after enrollment
Change in Physical Activity2 years after enrollment

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total645

Baseline characteristics

CharacteristicStandard Care With Education MaterialsModerate Dose Motivational InterviewingHigher Dose Motivational InterviewingTotal
Age, Categorical
<=18 years
198 Participants212 Participants235 Participants645 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous4.7 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 Participants64 Participants49 Participants139 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
152 Participants139 Participants180 Participants471 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
20 Participants9 Participants6 Participants35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
14 Participants3 Participants21 Participants38 Participants
Race (NIH/OMB)
Black or African American
5 Participants23 Participants14 Participants42 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
19 Participants8 Participants12 Participants39 Participants
Race (NIH/OMB)
White
160 Participants178 Participants188 Participants526 Participants
Region of Enrollment
United States
198 participants212 participants235 participants645 participants
Sex: Female, Male
Female
105 Participants121 Participants141 Participants367 Participants
Sex: Female, Male
Male
93 Participants91 Participants94 Participants278 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 1980 / 2120 / 235
serious
Total, serious adverse events
0 / 1980 / 2120 / 235

Outcome results

Primary

Child BMI Percentile

Time frame: 2 years after recruitment

ArmMeasureValue (MEAN)Dispersion
Standard Care With Education MaterialsChild BMI Percentile90.31 BMI PercentileStandard Error 0.94
Moderate Dose Motivational InterviewingChild BMI Percentile88.1 BMI PercentileStandard Error 0.94
Higher Dose Motivational InterviewingChild BMI Percentile87.1 BMI PercentileStandard Error 0.92
Secondary

Change in Physical Activity

Time frame: 2 years after enrollment

ArmMeasureValue (MEAN)Dispersion
Standard Care With Education MaterialsChange in Physical Activity2.1 Adjusted posttest hours per dayStandard Error 0.05
Moderate Dose Motivational InterviewingChange in Physical Activity1.9 Adjusted posttest hours per dayStandard Error 0.06
Higher Dose Motivational InterviewingChange in Physical Activity2.1 Adjusted posttest hours per dayStandard Error 0.06
Secondary

Fruit/Vegetable Consumption

Time frame: 2 years after enrollment

ArmMeasureValue (MEAN)Dispersion
Standard Care With Education MaterialsFruit/Vegetable Consumption3.8 Post test adjuste, servings per dayStandard Error 0.12
Moderate Dose Motivational InterviewingFruit/Vegetable Consumption4.1 Post test adjuste, servings per dayStandard Error 0.14
Higher Dose Motivational InterviewingFruit/Vegetable Consumption4.3 Post test adjuste, servings per dayStandard Error 0.13
Secondary

Sweetened Beverage Consumption

Time frame: 2 years after enrollment

ArmMeasureValue (MEAN)Dispersion
Standard Care With Education MaterialsSweetened Beverage Consumption1.3 Adjusted posted test servings per dayStandard Error 0.11
Moderate Dose Motivational InterviewingSweetened Beverage Consumption1.3 Adjusted posted test servings per dayStandard Error 0.11
Higher Dose Motivational InterviewingSweetened Beverage Consumption1.0 Adjusted posted test servings per dayStandard Error 0.12

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026