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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Mei-Wei Chang, Ohio State University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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



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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839708


Locations
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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
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Principal Investigator: Mei-Wei Chang, Ph.D Michigan State University College of Nursing
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Overweight
Weight Gain
Body Weight
Body Weight Changes