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 Description

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.

Condition or disease	Intervention/treatment	Phase
Overweight; Obesity	Behavioral: Lifestyle Counseling	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 569 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Mothers in Motion Program to Prevent Weight Gain in Overweight/Obese WIC Mothers (MIM)
• Actual Study Start Date: September 2011
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: March 31, 2017

Arms and Interventions

Arm	Intervention/treatment
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.	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
No Intervention: No Lifestyle Counseling; Comparison group: usual WIC care; read printed materials at home

Outcome Measures

Primary Outcome Measures :

1. Measured Body Weight [ Time Frame: 3 months after the 16-week intervention (T3) ]
   measured body weight in person at WIC office

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Measured Body Weight [ Time Frame: Immediatly after the 16-week intervention (T2) ]
    measured body weight in person at WIC office

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 39 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Michigan

Michigan State University

East Lansing, Michigan, United States, 48824

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

Investigators

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

More Information

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, Robbins LB, Ling J, Brown R, Wegener DT. Mediators affecting the association between a lifestyle behavior intervention and stress in low-income overweight or obese mothers of young children. J Health Psychol. 2021 Sep;26(10):1625-1636. doi: 10.1177/1359105319887780. Epub 2019 Nov 21.

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, Associate Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT01839708
• Other Study ID Numbers: 1R18DK083934-01A2 ( U.S. NIH Grant/Contract )
• First Posted: April 25, 2013
• Results First Posted: May 24, 2018
• Last Update Posted: May 24, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Mei-Wei Chang, Ohio State University:

Intervention

Additional relevant MeSH terms:

Overweight; Weight Gain; Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes