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Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM) (MIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01839708
Recruitment Status : Completed
First Posted : April 25, 2013
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mei-Wei Chang, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Overweight
Obesity
Intervention Behavioral: Lifestyle Counseling
Enrollment 569
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Period Title: Overall Study
Started 387 182
Completed 311 115
Not Completed 76 67
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling Total
Hide Arm/Group Description

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Total of all reporting groups
Overall Number of Baseline Participants 387 182 569
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 387 participants 182 participants 569 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
387
 100.0%
182
 100.0%
569
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 387 participants 182 participants 569 participants
Female
387
 100.0%
182
 100.0%
569
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 387 participants 182 participants 569 participants
387 182 569
1.Primary Outcome
Title Measured Body Weight
Hide Description measured body weight in person at WIC office
Time Frame 3 months after the 16-week intervention (T3)
Hide Outcome Measure Data
Hide Analysis Population Description
The inconsistent number of participants that were reported because we conducted general linear mixed model for repeated measures, which is a partial intention-to-treat analysis (ITT), adjusting baseline assessment. We chose to perform this method without any ad hoc imputation as our approach to ITT because the overall high dropout was high
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 196 115
Mean (Standard Error)
Unit of Measure: lbs
188.3  (10.6) 187.7  (10.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title T1 Fat Intake
Hide Description self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 387 182
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.59  (8.81) 21.75  (8.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title T1 Fruit and Vegetable Intake
Hide Description self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 387 182
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.3  (4.67) 10.89  (4.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title T1 Physical Activity
Hide Description Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 387 182
Mean (Standard Deviation)
Unit of Measure: hours
14.720  (54.949) 7.757  (19.723)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title T1 Stress
Hide Description Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 387 182
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.28  (0.56) 3.24  (0.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title T2 Fat Intake
Hide Description self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.
Time Frame immediately after the 16-week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 212 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.16  (7.43) 18.99  (10.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title T3 Fat Intake
Hide Description self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.
Time Frame 3-month after the 16-week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 196 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.42  (8.96) 17.22  (10.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
8.Secondary Outcome
Title T2 Fruit and Vegetable Intake
Hide Description self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.
Time Frame immediately after the 16-week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 212 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.11  (4.08) 10.90  (4.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title T3 Fruit and Vegetable Intake
Hide Description self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.
Time Frame 3-month after the 16-week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 196 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.77  (4.90) 10.97  (6.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title T2 Physical Activity
Hide Description Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.
Time Frame immediatly after the 16-week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 213 127
Mean (Standard Deviation)
Unit of Measure: Hours
5.389  (25.953) 4.967  (12.290)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title T3 Physical Activity
Hide Description Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.
Time Frame 3-month after the 16-week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 198 116
Mean (Standard Deviation)
Unit of Measure: Hours
4.417  (16.273) 3.666  (12.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
12.Secondary Outcome
Title T2 Stress
Hide Description Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
Time Frame immediatly after the 16-week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 212 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.56  (0.358) 2.44  (0.356)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
13.Secondary Outcome
Title T3 Stress
Hide Description Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
Time Frame 3-month after the 16-week intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 196 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.55  (0.35) 2.51  (0.356)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
14.Secondary Outcome
Title Measured Body Weight
Hide Description measured body weight in person at WIC office
Time Frame Immediatly after the 16-week intervention (T2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description:

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Overall Number of Participants Analyzed 219 124
Mean (Standard Deviation)
Unit of Measure: lbs
188.45  (10.84) 188.52  (10.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Counseling, No Lifestyle Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Immediately after the 16-week intervention (T2) and 3 months after the 16-week intervention (T3)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lifestyle Counseling No Lifestyle Counseling
Hide Arm/Group Description

Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

Comparison group: usual WIC care; read printed materials at home

Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.

All-Cause Mortality
Lifestyle Counseling No Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/387 (0.00%)   0/182 (0.00%) 
Hide Serious Adverse Events
Lifestyle Counseling No Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/387 (0.00%)   0/182 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lifestyle Counseling No Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/387 (0.00%)   0/182 (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: Mei-Wei Chang
Organization: Ohio State University
Phone: (614) 292-4041
EMail: chang.1572@osu.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mei-Wei Chang, Ohio State University
ClinicalTrials.gov Identifier: NCT01839708    
Other Study ID Numbers: 1R18DK083934-01A2 ( U.S. NIH Grant/Contract )
First Submitted: February 28, 2013
First Posted: April 25, 2013
Results First Submitted: November 22, 2017
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018