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

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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

Tracking Information
First Submitted Date  ICMJE February 28, 2013
First Posted Date  ICMJE April 25, 2013
Results First Submitted Date  ICMJE November 22, 2017
Results First Posted Date  ICMJE May 24, 2018
Last Update Posted Date May 24, 2018
Actual Study Start Date  ICMJE September 2011
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2018)
569
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2013)
525
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01839708
Other Study ID Numbers  ICMJE 1R18DK083934-01A2( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mei-Wei Chang, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mei-Wei Chang, Ph.D Michigan State University College of Nursing
PRS Account Ohio State University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP