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

Tracking Information

• First Submitted Date: February 28, 2013
• First Posted Date: April 25, 2013
• Results First Submitted Date: November 22, 2017
• Results First Posted Date: May 24, 2018
• Last Update Posted Date: May 24, 2018
• Actual Study Start Date: September 2011
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2018)

Measured Body Weight [ Time Frame: 3 months after the 16-week intervention (T3) ]

measured body weight in person at WIC office

Original Primary Outcome Measures (submitted: April 22, 2013)

• body weight [ Time Frame: Baseline ]
• body weight [ Time Frame: immediatly after the 16-week intervention ]
• body weight [ Time Frame: 3 months after the 16-week intervention ]

Current Secondary Outcome Measures (submitted: April 27, 2018)

• T1 Fat Intake [ Time Frame: 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.
• T1 Fruit and Vegetable Intake [ Time Frame: 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.
• T1 Physical Activity [ Time Frame: 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.
• T1 Stress [ Time Frame: 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.
• T2 Fat Intake [ Time Frame: 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.
• T3 Fat Intake [ Time Frame: 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.
• T2 Fruit and Vegetable Intake [ Time Frame: 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.
• T3 Fruit and Vegetable Intake [ Time Frame: 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.
• T2 Physical Activity [ Time Frame: 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.
• T3 Physical Activity [ Time Frame: 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.
• T2 Stress [ Time Frame: 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.
• T3 Stress [ Time Frame: 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.
• Measured Body Weight [ Time Frame: Immediatly after the 16-week intervention (T2) ]
  measured body weight in person at WIC office

Original Secondary Outcome Measures (submitted: April 22, 2013)

• Fat intake [ Time Frame: baseline ]
• fruit and vegetable intake [ Time Frame: baseline ]
• physical activity [ Time Frame: baseline ]
• stress [ Time Frame: baseline ]
• fat intake [ Time Frame: immediatly after the 16-week intervention ]
• fat intake [ Time Frame: 3-month after the 16-week intervention ]
• fruit and vegetable intake [ Time Frame: immediatly after the 16-week intervention ]
• fruit and vegetable intake [ Time Frame: 3-month after the 16-week intervention ]
• physical activity [ Time Frame: immediatly after the 16-week intervention ]
• physical activity [ Time Frame: 3-month after the 16-week intervention ]
• stress [ Time Frame: immediatly after the 16-week intervention ]
• stress [ Time Frame: 3-month after the 16-week intervention ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM)
• Official Title: Mothers in Motion Program to Prevent Weight Gain in Overweight/Obese WIC Mothers (MIM)
• Brief Summary: Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children. The intervention group's weight change (difference between the initial enrollment and 3 months post intervention) will differ from the control group's weight change by an average of at least 2.8 pounds.
• Detailed Description: Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children. Both treatment groups will receive usual WIC care (nutrition counseling and similar services). The control group will receive generic printed health and nutrition materials to read at their own pace if they wish. The intervention group will watch the culturally sensitive DVD chapters according to a study calendar, complete action plan worksheets, and call in to peer support group teleconferences to discuss the DVD chapter contents. The teleconferences will be led by moderators trained in motivational interviewing (MI) and group facilitation. Participants will complete phone interviews and provide body weight measurements at baseline (T1), immediately after (T2) and 3 months after (T3) the intervention time period. T3 body weight will be the primary outcome.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Overweight
• Obesity

Intervention

Behavioral: 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.

Other Name: Motivational Interviewing

Study Arms

• Experimental: 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.
  Intervention: Behavioral: Lifestyle Counseling
• No Intervention: No Lifestyle Counseling
  Comparison group: usual WIC care; read printed materials at home

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2018): 569
• Original Estimated Enrollment (submitted: April 22, 2013): 525
• Actual Study Completion Date: March 31, 2017
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• African American or White
• Fluent in English
• 18-39 years old
• At least 6 weeks postpartum
• Body Mass Index (BMI) between 25.0 and 39.9
• Willing to provide address and up to 3 working phone numbers
• Willing to update their contact information monthly
• Willing to participate in the project for 9 months
• Willing to make 3 additional trips to WIC clinics for weight measures
• Working DVD player at home and access to a working phone.

Exclusion Criteria:

• Pregnant
• MIM Pilot study participation
• Plan to become pregnant or relocate to a location outside of study area during the trial
• Self-reported type 1 or 2 Diabetes
• Unable to walk more than 1 block without resting or shortness of breath.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 39 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01839708
• Other Study ID Numbers: 1R18DK083934-01A2( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Mei-Wei Chang, Ohio State University
• Study Sponsor: Ohio State University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mei-Wei Chang, Ph.D; Michigan State University College of Nursing

• PRS Account: Ohio State University
• Verification Date: April 2018