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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

569 participants

Primary outcome timeframe

3 months after the 16-week intervention (T3)

Results posted on

2018-05-24

Participant Flow

Participant milestones

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

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

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: baseline

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.

Outcome measures

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: baseline

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.

Outcome measures

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: baseline

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.

Outcome measures

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: baseline

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.

Outcome measures

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 intervention

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.

Outcome measures

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 intervention

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.

Outcome measures

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 intervention

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.

Outcome measures

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 intervention

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.

Outcome measures

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 intervention

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.

Outcome measures

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 intervention

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.

Outcome measures

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 intervention

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.

Outcome measures

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 intervention

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.

Outcome measures

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Lifestyle Counseling

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mei-Wei Chang

Ohio State University

Phone: (614) 292-4041

Results disclosure agreements

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