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

• 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: Ohio State University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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

Baseline Characteristics

Arm/Group Title		Lifestyle Counseling	No Lifestyle Counseling	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Measured Body Weight
Description	measured body weight in person at WIC office
Time Frame	3 months after the 16-week intervention (T3)

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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
Description	measured body weight in person at WIC office
Time Frame	Immediatly after the 16-week intervention (T2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	No Lifestyle Counseling
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)

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]

Adverse Events

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
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%)
Serious Adverse Events
	Lifestyle Counseling	No Lifestyle Counseling
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/387 (0.00%)	0/182 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Mei-Wei Chang
• Organization: Ohio State University
• Phone: (614) 292-4041
• EMail: chang.1572@osu.edu

Publications of Results:

Chang MW, Brown R, Nitzke S. Results and lessons learned from a prevention of weight gain program for low-income overweight and obese young mothers: Mothers In Motion. BMC Public Health. 2017 Feb 10;17(1):182. doi: 10.1186/s12889-017-4109-y.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chang MW, Brown R, Wegener DT. Perceived stress linking psychosocial factors and depressive symptoms in low-income mothers. BMC Public Health. 2021 Jan 6;21(1):62. doi: 10.1186/s12889-020-10118-4.

Chang MW, Brown R, Wegener DT, Brill S, Schaffir J, Hu J. Chaos and psychosocial health in low-income overweight or obese women. Health Psychol. 2019 Dec;38(12):1159-1167. doi: 10.1037/hea0000813. Epub 2019 Oct 3.

Chang MW, Tan A, Schaffir J, Wegener DT. Sleep and weight loss in low-income overweight or obese postpartum women. BMC Obes. 2019 Apr 1;6:12. doi: 10.1186/s40608-019-0236-6. eCollection 2019.

Chang MW, Nitzke S, Brown R. Mothers In Motion intervention effect on psychosocial health in young, low-income women with overweight or obesity. BMC Public Health. 2019 Jan 14;19(1):56. doi: 10.1186/s12889-019-6404-2.

Chang MW, Brown R, Nitzke S. A Community-Based Intervention Program's Effects on Dietary Intake Behaviors. Obesity (Silver Spring). 2017 Dec;25(12):2055-2061. doi: 10.1002/oby.21862. Epub 2017 Oct 31.

Chang MW, Hales D, Brown R, Ward D, Resnicow K, Nitzke S. Validation of PIN 3 physical activity survey in low-income overweight and obese young mothers. BMC Public Health. 2015 Feb 10;15:121. doi: 10.1186/s12889-015-1493-z.

Chang MW, Nitzke S, Brown R, Resnicow K. A community based prevention of weight gain intervention (Mothers In Motion) among young low-income overweight and obese mothers: design and rationale. BMC Public Health. 2014 Mar 25;14:280. doi: 10.1186/1471-2458-14-280.

• 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