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

Obesity Clinical Trial

— MIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839708
• Other study ID #: 1R18DK083934-01A2
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: March 31, 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Gain

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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured Body Weight	measured body weight in person at WIC office	3 months after the 16-week intervention (T3)
Secondary	T1 Fat Intake	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.	baseline
Secondary	T1 Fruit and Vegetable Intake	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.	baseline
Secondary	T1 Physical Activity	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.	baseline
Secondary	T1 Stress	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.	baseline
Secondary	T2 Fat Intake	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.	immediately after the 16-week intervention
Secondary	T3 Fat Intake	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.	3-month after the 16-week intervention
Secondary	T2 Fruit and Vegetable Intake	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.	immediately after the 16-week intervention
Secondary	T3 Fruit and Vegetable Intake	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-month after the 16-week intervention
Secondary	T2 Physical Activity	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.	immediatly after the 16-week intervention
Secondary	T3 Physical Activity	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.	3-month after the 16-week intervention
Secondary	T2 Stress	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.	immediatly after the 16-week intervention
Secondary	T3 Stress	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.	3-month after the 16-week intervention
Secondary	Measured Body Weight	measured body weight in person at WIC office	Immediatly after the 16-week intervention (T2)