Trial Outcomes & Findings for Brief Motivational Interviewing to Reduce Child Body Mass Index (NCT NCT01335308)

NCT ID: NCT01335308

Last Updated: 2023-10-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 645 participants
• Primary outcome timeframe: 2 years after recruitment
• Results posted on: 2023-10-13

Participant Flow

Participant milestones

Measure	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	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	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
Overall Study STARTED	198	212	235
Overall Study COMPLETED	158	145	154
Overall Study NOT COMPLETED	40	67	81

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brief Motivational Interviewing to Reduce Child Body Mass Index

Baseline characteristics by cohort

Measure	Standard Care With Education Materials n=198 Participants 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	Moderate Dose Motivational Interviewing n=212 Participants 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	Higher Dose Motivational Interviewing n=235 Participants 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	Total n=645 Participants Total of all reporting groups
Age, Categorical <=18 years	198 Participants n=5 Participants	212 Participants n=7 Participants	235 Participants n=5 Participants	645 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	4.7 YEARS STANDARD_DEVIATION 1.7 • n=5 Participants	5.1 YEARS STANDARD_DEVIATION 1.9 • n=7 Participants	5.3 YEARS STANDARD_DEVIATION 1.8 • n=5 Participants	5.1 YEARS STANDARD_DEVIATION 1.8 • n=4 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	121 Participants n=7 Participants	141 Participants n=5 Participants	367 Participants n=4 Participants
Sex: Female, Male Male	93 Participants n=5 Participants	91 Participants n=7 Participants	94 Participants n=5 Participants	278 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	64 Participants n=7 Participants	49 Participants n=5 Participants	139 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	152 Participants n=5 Participants	139 Participants n=7 Participants	180 Participants n=5 Participants	471 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	3 Participants n=7 Participants	21 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	23 Participants n=7 Participants	14 Participants n=5 Participants	42 Participants n=4 Participants
Race (NIH/OMB) White	160 Participants n=5 Participants	178 Participants n=7 Participants	188 Participants n=5 Participants	526 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	39 Participants n=4 Participants
Region of Enrollment United States	198 participants n=5 Participants	212 participants n=7 Participants	235 participants n=5 Participants	645 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 years after recruitment

Outcome measures

Measure	Standard Care With Education Materials n=158 Participants 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	Moderate Dose Motivational Interviewing n=145 Participants 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	Higher Dose Motivational Interviewing n=154 Participants 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
Child BMI Percentile	90.31 BMI Percentile Standard Error .94	88.1 BMI Percentile Standard Error .94	87.1 BMI Percentile Standard Error .92

SECONDARY outcome

Timeframe: 2 years after enrollment

Outcome measures

Measure	Standard Care With Education Materials n=158 Participants 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	Moderate Dose Motivational Interviewing n=145 Participants 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	Higher Dose Motivational Interviewing n=154 Participants 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
Fruit/Vegetable Consumption	3.8 Post test adjuste, servings per day Standard Error .12	4.1 Post test adjuste, servings per day Standard Error .14	4.3 Post test adjuste, servings per day Standard Error .13

SECONDARY outcome

Timeframe: 2 years after enrollment

Outcome measures

Measure	Standard Care With Education Materials n=158 Participants 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	Moderate Dose Motivational Interviewing n=145 Participants 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	Higher Dose Motivational Interviewing n=154 Participants 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
Sweetened Beverage Consumption	1.3 Adjusted posted test servings per day Standard Error .11	1.3 Adjusted posted test servings per day Standard Error .11	1.0 Adjusted posted test servings per day Standard Error .12

SECONDARY outcome

Timeframe: 2 years after enrollment

Outcome measures

Measure	Standard Care With Education Materials n=158 Participants 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	Moderate Dose Motivational Interviewing n=145 Participants 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	Higher Dose Motivational Interviewing n=154 Participants 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
Change in Physical Activity	2.1 Adjusted posttest hours per day Standard Error .05	1.9 Adjusted posttest hours per day Standard Error .06	2.1 Adjusted posttest hours per day Standard Error .06

Adverse Events

Standard Care With Education Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate Dose Motivational Interviewing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Higher Dose Motivational Interviewing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ken Resnicow

University of Michigan

Phone: 734 647 0212

Email: kresnic@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place