Trial Outcomes & Findings for Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM) (NCT NCT01839708)
NCT ID: NCT01839708
Last Updated: 2018-05-24
Results Overview
measured body weight in person at WIC office
COMPLETED
NA
569 participants
3 months after the 16-week intervention (T3)
2018-05-24
Participant Flow
Participant milestones
| Measure |
Lifestyle Counseling
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.
|
No Lifestyle Counseling
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 Study
STARTED
|
387
|
182
|
|
Overall Study
COMPLETED
|
311
|
115
|
|
Overall Study
NOT COMPLETED
|
76
|
67
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM)
Baseline characteristics by cohort
| Measure |
Lifestyle Counseling
n=387 Participants
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.
|
No Lifestyle Counseling
n=182 Participants
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
n=569 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
387 Participants
n=99 Participants
|
182 Participants
n=107 Participants
|
569 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
387 Participants
n=99 Participants
|
182 Participants
n=107 Participants
|
569 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
387 participants
n=99 Participants
|
182 participants
n=107 Participants
|
569 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months after the 16-week intervention (T3)Population: 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
measured body weight in person at WIC office
Outcome measures
| Measure |
Lifestyle Counseling
n=196 Participants
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.
|
No Lifestyle Counseling
n=115 Participants
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.
|
|---|---|---|
|
Measured Body Weight
|
188.3 lbs
Standard Error 10.6
|
187.7 lbs
Standard Error 10.6
|
SECONDARY outcome
Timeframe: baselineself-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=387 Participants
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.
|
No Lifestyle Counseling
n=182 Participants
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.
|
|---|---|---|
|
T1 Fat Intake
|
22.59 units on a scale
Standard Deviation 8.81
|
21.75 units on a scale
Standard Deviation 8.89
|
SECONDARY outcome
Timeframe: baselineself-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=387 Participants
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.
|
No Lifestyle Counseling
n=182 Participants
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.
|
|---|---|---|
|
T1 Fruit and Vegetable Intake
|
11.3 units on a scale
Standard Deviation 4.67
|
10.89 units on a scale
Standard Deviation 4.64
|
SECONDARY outcome
Timeframe: baselineSelf-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=387 Participants
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.
|
No Lifestyle Counseling
n=182 Participants
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.
|
|---|---|---|
|
T1 Physical Activity
|
14.720 hours
Standard Deviation 54.949
|
7.757 hours
Standard Deviation 19.723
|
SECONDARY outcome
Timeframe: baselineSelf-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=387 Participants
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.
|
No Lifestyle Counseling
n=182 Participants
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.
|
|---|---|---|
|
T1 Stress
|
3.28 units on a scale
Standard Deviation 0.56
|
3.24 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: immediately after the 16-week interventionself-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=212 Participants
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.
|
No Lifestyle Counseling
n=126 Participants
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.
|
|---|---|---|
|
T2 Fat Intake
|
17.16 units on a scale
Standard Deviation 7.43
|
18.99 units on a scale
Standard Deviation 10.90
|
SECONDARY outcome
Timeframe: 3-month after the 16-week interventionself-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=196 Participants
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.
|
No Lifestyle Counseling
n=115 Participants
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.
|
|---|---|---|
|
T3 Fat Intake
|
18.42 units on a scale
Standard Deviation 8.96
|
17.22 units on a scale
Standard Deviation 10.94
|
SECONDARY outcome
Timeframe: immediately after the 16-week interventionself-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=212 Participants
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.
|
No Lifestyle Counseling
n=126 Participants
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.
|
|---|---|---|
|
T2 Fruit and Vegetable Intake
|
11.11 units on a scale
Standard Deviation 4.08
|
10.90 units on a scale
Standard Deviation 4.15
|
SECONDARY outcome
Timeframe: 3-month after the 16-week interventionself-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=196 Participants
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.
|
No Lifestyle Counseling
n=115 Participants
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.
|
|---|---|---|
|
T3 Fruit and Vegetable Intake
|
11.77 units on a scale
Standard Deviation 4.90
|
10.97 units on a scale
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: immediatly after the 16-week interventionSelf-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=213 Participants
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.
|
No Lifestyle Counseling
n=127 Participants
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.
|
|---|---|---|
|
T2 Physical Activity
|
5.389 Hours
Standard Deviation 25.953
|
4.967 Hours
Standard Deviation 12.290
|
SECONDARY outcome
Timeframe: 3-month after the 16-week interventionSelf-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=198 Participants
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.
|
No Lifestyle Counseling
n=116 Participants
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.
|
|---|---|---|
|
T3 Physical Activity
|
4.417 Hours
Standard Deviation 16.273
|
3.666 Hours
Standard Deviation 12.000
|
SECONDARY outcome
Timeframe: immediatly after the 16-week interventionSelf-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=212 Participants
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.
|
No Lifestyle Counseling
n=126 Participants
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.
|
|---|---|---|
|
T2 Stress
|
2.56 units on a scale
Standard Deviation 0.358
|
2.44 units on a scale
Standard Deviation 0.356
|
SECONDARY outcome
Timeframe: 3-month after the 16-week interventionSelf-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.
Outcome measures
| Measure |
Lifestyle Counseling
n=196 Participants
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.
|
No Lifestyle Counseling
n=115 Participants
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.
|
|---|---|---|
|
T3 Stress
|
2.55 units on a scale
Standard Deviation 0.35
|
2.51 units on a scale
Standard Deviation 0.356
|
SECONDARY outcome
Timeframe: Immediatly after the 16-week intervention (T2)measured body weight in person at WIC office
Outcome measures
| Measure |
Lifestyle Counseling
n=219 Participants
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.
|
No Lifestyle Counseling
n=124 Participants
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.
|
|---|---|---|
|
Measured Body Weight
|
188.45 lbs
Standard Deviation 10.84
|
188.52 lbs
Standard Deviation 10.87
|
Adverse Events
Lifestyle Counseling
No Lifestyle Counseling
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place