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临床试验/NCT01839708
NCT01839708已完成不适用

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

Ohio State University4 个研究点 分布在 1 个国家目标入组 569 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
569
试验地点
4
主要终点
Measured Body Weight

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Lifestyle Counseling (Behavioral)

No Lifestyle Counseling

No Intervention

Comparison group: usual WIC care; read printed materials at home

结局指标

主要结局

Measured Body Weight

时间窗: 3 months after the 16-week intervention (T3)

measured body weight in person at WIC office

次要结局

  • T1 Physical Activity(baseline)
  • T2 Fat Intake(immediately after the 16-week intervention)
  • T3 Fat Intake(3-month after the 16-week intervention)
  • T1 Fat Intake(baseline)
  • T1 Stress(baseline)
  • T3 Fruit and Vegetable Intake(3-month after the 16-week intervention)
  • T2 Physical Activity(immediatly after the 16-week intervention)
  • Measured Body Weight(Immediatly after the 16-week intervention (T2))
  • T2 Fruit and Vegetable Intake(immediately after the 16-week intervention)
  • T1 Fruit and Vegetable Intake(baseline)
  • T3 Physical Activity(3-month after the 16-week intervention)
  • T2 Stress(immediatly after the 16-week intervention)
  • T3 Stress(3-month after the 16-week intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mei-Wei Chang

Associate Professor

Ohio State University

研究点 (4)

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