OverweightMIMNCT01839708
Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM)
A study testing Lifestyle Counseling in people with Overweight and Obesity, run by Ohio State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 569 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University
Columbus, Ohio, 43210
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: Mothers in Motion Program to Prevent Weight Gain in Overweight/Obese WIC Mothers (MIM)
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Lifestyle Counseling
- Keywords
- Intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingBehavioural
Also called Motivational Interviewing
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Counseling | Experimental | Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions. Receives: Behavioral: Lifestyle Counseling |
| No Lifestyle Counseling | No intervention | Comparison group: usual WIC care; read printed materials at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured Body Weight
measured body weight in person at WIC office
Measured: 3 months after the 16-week intervention (T3)
Secondary outcomes (13)
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: immediately after the 16-week intervention
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.
Measured: 3-month after the 16-week intervention
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.
Measured: immediately after the 16-week intervention
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.
Measured: 3-month after the 16-week intervention
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.
Measured: immediatly after the 16-week intervention
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.
Measured: 3-month after the 16-week intervention
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.
Measured: immediatly after the 16-week intervention
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.
Measured: 3-month after the 16-week intervention
Measured Body Weight
measured body weight in person at WIC office
Measured: Immediatly after the 16-week intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2015
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Wei Chang, Ohio State University
- Investigators
- Mei-Wei Chang, Ph.D, Principal investigator, Michigan State University College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839708
- Sponsor's protocol ID
- 1R18DK083934-01A2
- Acronym
- MIM
- Status last verified
- Apr 2018
- First submitted
- 28 Feb 2013
- Last updated
- 24 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 28187726Chang 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.
PubMed 33407305Chang 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.
PubMed 31749377Chang 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.
PubMed 31580130Chang 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.
PubMed 30984405Chang 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.
PubMed 30642311Chang 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.
PubMed 29086490Chang 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.
PubMed 25885482Chang 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.
PubMed 24666633
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers in Motion Program to Prevent Weight Gain in Overweight/Obese WIC Mothers (MIM)
- ClinicalTrials.gov ID
- NCT01839708
- Acronym / sponsor ID
- MIM / 1R18DK083934-01A2
- Conditions
- Overweight, Obesity
- Keywords
- Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Posted 24 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Counseling | Experimental | Behavioral: Lifestyle CounselingIntervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions. |
| No Lifestyle Counseling | No intervention | –Comparison group: usual WIC care; read printed materials at home |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle CounselingAlso: Motivational InterviewingThe 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. | Behavioural | Lifestyle Counseling |
Primary outcome
Measured Body Weight
Time frame: 3 months after the 16-week intervention (T3)
measured body weight in person at WIC office
13 secondary outcomes
T1 Fat Intake
Time frame: baseline
T1 Fruit and Vegetable Intake
Time frame: baseline
T1 Physical Activity
Time frame: baseline
T1 Stress
Time frame: baseline
T2 Fat Intake
Time frame: immediately after the 16-week intervention
T3 Fat Intake
Time frame: 3-month after the 16-week intervention
T2 Fruit and Vegetable Intake
Time frame: immediately after the 16-week intervention
T3 Fruit and Vegetable Intake
Time frame: 3-month after the 16-week intervention
T2 Physical Activity
Time frame: immediatly after the 16-week intervention
T3 Physical Activity
Time frame: 3-month after the 16-week intervention
T2 Stress
Time frame: immediatly after the 16-week intervention
T3 Stress
Time frame: 3-month after the 16-week intervention
Measured Body Weight
Time frame: Immediatly after the 16-week intervention (T2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28187726Chang 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.
- Derived from this study: PubMed 33407305Chang 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.
- Derived from this study: PubMed 31749377Chang 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.
- Derived from this study: PubMed 31580130Chang 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.
- Derived from this study: PubMed 30984405Chang 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.
- Derived from this study: PubMed 30642311Chang 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.
- Derived from this study: PubMed 29086490Chang 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.
- Derived from this study: PubMed 25885482Chang 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.
- Derived from this study: PubMed 24666633Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Wei Chang, Ph.D principal investigator
Michigan State University College of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Counseling in people with Overweight and Obesity, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured Body Weight (time frame: 3 months after the 16-week intervention (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839708, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.