Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM) (MIM)
2018年4月27日 更新者：Mei-Wei Chang、Ohio State University
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
569
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Michigan
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East Lansing、Michigan、アメリカ、48824
- Michigan State University
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Ohio
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Columbus、Ohio、アメリカ、43210
- The Ohio State University
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～39年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Lifestyle Counseling
Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.
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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.
他の名前：
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介入なし：No Lifestyle Counseling
Comparison group: usual WIC care; read printed materials at home
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measured Body Weight
時間枠：3 months after the 16-week intervention (T3)
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measured body weight in person at WIC office
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3 months after the 16-week intervention (T3)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
T1 Fat Intake
時間枠：baseline
|
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
|
|
T1 Fruit and Vegetable Intake
時間枠：baseline
|
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
|
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T1 Physical Activity
時間枠：baseline
|
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
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T1 Stress
時間枠：baseline
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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
|
|
T2 Fat Intake
時間枠：immediately after the 16-week intervention
|
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
|
|
T3 Fat Intake
時間枠：3-month after the 16-week intervention
|
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
|
|
T2 Fruit and Vegetable Intake
時間枠：immediately after the 16-week intervention
|
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
|
|
T3 Fruit and Vegetable Intake
時間枠：3-month after the 16-week intervention
|
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
|
|
T2 Physical Activity
時間枠：immediatly after the 16-week intervention
|
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
|
|
T3 Physical Activity
時間枠：3-month after the 16-week intervention
|
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
|
|
T2 Stress
時間枠：immediatly after the 16-week intervention
|
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
|
|
T3 Stress
時間枠：3-month after the 16-week intervention
|
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
|
|
Measured Body Weight
時間枠：Immediatly after the 16-week intervention (T2)
|
measured body weight in person at WIC office
|
Immediatly after the 16-week intervention (T2)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Mei-Wei Chang, Ph.D、Michigan State University College of Nursing
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2011年9月1日
一次修了 (実際)
2015年9月1日
研究の完了 (実際)
2017年3月31日
試験登録日
最初に提出
2013年2月28日
QC基準を満たした最初の提出物
2013年4月22日
最初の投稿 (見積もり)
2013年4月25日
学習記録の更新
投稿された最後の更新 (実際)
2018年5月24日
QC基準を満たした最後の更新が送信されました
2018年4月27日
最終確認日
2018年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Lifestyle Counselingの臨床試験
-
Oxford Biomedical Technologies, Inc.募集
-
Universiti Sultan Zainal Abidin募集
-
University of Alabama at Birmingham積極的、募集していない