Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatment lifestyle counseling
Phase phase 3
Sponsor Michigan State University
Start date September 2011
End date October 2015
Trial size 620 participants
Trial identifier NCT01839708, 1R18DK083934-01A2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(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.
lifestyle counseling 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.
(Other)
Comparison group: usual WIC care; read printed materials at home
lifestyle counseling 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.

Primary Outcomes

Measure
T3 body weight
time frame: 3 months after the 16-week intervention

Secondary Outcomes

Measure
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: immediatly after the 16-week intervention
T3 fat intake
time frame: 3-month after the 16-week intervention
T2 fruit and vegetable intake
time frame: immediatly 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
T2 body weight
time frame: immediatly after the 16-week intervention
T1 body weight
time frame: baseline

Eligibility Criteria

Female participants from 18 years up to 39 years old.

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.

Additional Information

Official title Mothers in Motion Program to Prevent Weight Gain in Overweight/Obese WIC Mothers (MIM)
Principal investigator Mei-Wei Chang, Ph.D
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 factilitation. 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Michigan State University.