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Brief Motivational Interviewing to Reduce Child Body Mass Index (BMi2)

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ClinicalTrials.gov Identifier: NCT01335308
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Academy of Pediatrics
Academy of Nutrition and Dietetics
University of Iowa
Information provided by (Responsible Party):
Ken Resnicow, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Childhood Obesity
Interventions Behavioral: Standard Care
Behavioral: Moderate Dose Motivational Interviewing
Behavioral: Higher Dose Motivational Interviewing
Enrollment 645
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Hide Arm/Group Description 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: 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: 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
Period Title: Overall Study
Started 198 212 235
Completed 158 145 154
Not Completed 40 67 81
Arm/Group Title Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing Total
Hide Arm/Group Description 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: 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: 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 of all reporting groups
Overall Number of Baseline Participants 198 212 235 645
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 212 participants 235 participants 645 participants
<=18 years
198
 100.0%
212
 100.0%
235
 100.0%
645
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  YEARS
Number Analyzed 198 participants 212 participants 235 participants 645 participants
4.7  (1.7) 5.1  (1.9) 5.3  (1.8) 5.1  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 212 participants 235 participants 645 participants
Female
105
  53.0%
121
  57.1%
141
  60.0%
367
  56.9%
Male
93
  47.0%
91
  42.9%
94
  40.0%
278
  43.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 212 participants 235 participants 645 participants
Hispanic or Latino
26
  13.1%
64
  30.2%
49
  20.9%
139
  21.6%
Not Hispanic or Latino
152
  76.8%
139
  65.6%
180
  76.6%
471
  73.0%
Unknown or Not Reported
20
  10.1%
9
   4.2%
6
   2.6%
35
   5.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 212 participants 235 participants 645 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
14
   7.1%
3
   1.4%
21
   8.9%
38
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   2.5%
23
  10.8%
14
   6.0%
42
   6.5%
White
160
  80.8%
178
  84.0%
188
  80.0%
526
  81.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
19
   9.6%
8
   3.8%
12
   5.1%
39
   6.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 198 participants 212 participants 235 participants 645 participants
198 212 235 645
1.Primary Outcome
Title Child BMI Percentile
Hide Description [Not Specified]
Time Frame 2 years after recruitment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Hide Arm/Group Description:
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: 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: 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 Number of Participants Analyzed 158 145 154
Mean (Standard Error)
Unit of Measure: BMI Percentile
90.31  (.94) 88.1  (.94) 87.1  (.92)
2.Secondary Outcome
Title Fruit/Vegetable Consumption
Hide Description [Not Specified]
Time Frame 2 years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Hide Arm/Group Description:
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: 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: 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 Number of Participants Analyzed 158 145 154
Mean (Standard Error)
Unit of Measure: Post test adjuste, servings per day
3.8  (.12) 4.1  (.14) 4.3  (.13)
3.Secondary Outcome
Title Sweetened Beverage Consumption
Hide Description [Not Specified]
Time Frame 2 years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Hide Arm/Group Description:
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: 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: 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 Number of Participants Analyzed 158 145 154
Mean (Standard Error)
Unit of Measure: Adjusted posted test servings per day
1.3  (.11) 1.3  (.11) 1.0  (.12)
4.Secondary Outcome
Title Change in Physical Activity
Hide Description [Not Specified]
Time Frame 2 years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Hide Arm/Group Description:
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: 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: 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 Number of Participants Analyzed 158 145 154
Mean (Standard Error)
Unit of Measure: Adjusted posttest hours per day
2.1  (.05) 1.9  (.06) 2.1  (.06)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Hide Arm/Group Description 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: 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: 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
All-Cause Mortality
Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/198 (0.00%)   0/212 (0.00%)   0/235 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Care With Education Materials Moderate Dose Motivational Interviewing Higher Dose Motivational Interviewing
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/198 (0.00%)   0/212 (0.00%)   0/235 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ken Resnicow
Organization: University of Michigan
Phone: 734 647 0212
EMail: kresnic@umich.edu
Layout table for additonal information
Responsible Party: Ken Resnicow, University of Michigan
ClinicalTrials.gov Identifier: NCT01335308    
Other Study ID Numbers: HL085400
5R01HL085400 ( U.S. NIH Grant/Contract )
First Submitted: April 12, 2011
First Posted: April 14, 2011
Results First Submitted: October 28, 2016
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017