Clinical trial NCT01839708: Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM)
Official title: Mothers in Motion Program to Prevent Weight Gain in Overweight/Obese WIC Mothers (MIM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Intervention
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 569
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Measured Body Weight
timeFrame: 3 months after the 16-week intervention (T3)
Secondary outcomes:
measure: T1 Fat Intake
timeFrame: baseline
measure: T1 Fruit and Vegetable Intake
timeFrame: baseline
measure: T1 Physical Activity
timeFrame: baseline
measure: T1 Stress
timeFrame: baseline
measure: T2 Fat Intake
timeFrame: immediately after the 16-week intervention
measure: T3 Fat Intake
timeFrame: 3-month after the 16-week intervention
measure: T2 Fruit and Vegetable Intake
timeFrame: immediately after the 16-week intervention
measure: T3 Fruit and Vegetable Intake
timeFrame: 3-month after the 16-week intervention
measure: T2 Physical Activity
timeFrame: immediatly after the 16-week intervention
measure: T3 Physical Activity
timeFrame: 3-month after the 16-week intervention
measure: T2 Stress
timeFrame: immediatly after the 16-week intervention
measure: T3 Stress
timeFrame: 3-month after the 16-week intervention
measure: Measured Body Weight
timeFrame: Immediatly after the 16-week intervention (T2)
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Michigan State University College of Nursing
name: Mei-Wei Chang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.