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

27. April 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

569

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Michigan
      • East Lansing, Michigan, Vereinigte Staaten, 48824
        • Michigan State University
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • The Ohio State University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 39 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Lifestyle Counseling
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.
Andere Namen:
  • Motivierende Gesprächsführung
Kein Eingriff: No Lifestyle Counseling
Comparison group: usual WIC care; read printed materials at home

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Measured Body Weight
Zeitfenster: 3 months after the 16-week intervention (T3)
measured body weight in person at WIC office
3 months after the 16-week intervention (T3)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
T1 Fat Intake
Zeitfenster: 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
Zeitfenster: 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
T1 Physical Activity
Zeitfenster: 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
T1 Stress
Zeitfenster: baseline
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Immediatly after the 16-week intervention (T2)
measured body weight in person at WIC office
Immediatly after the 16-week intervention (T2)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ohio State University

Ermittler

  • Hauptermittler: Mei-Wei Chang, Ph.D, Michigan State University College of Nursing

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. September 2011

Primärer Abschluss (Tatsächlich)

1. September 2015

Studienabschluss (Tatsächlich)

31. März 2017

Studienanmeldedaten

Zuerst eingereicht

28. Februar 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. April 2013

Zuerst gepostet (Schätzen)

25. April 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Mai 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2018

Zuletzt verifiziert

1. April 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1R18DK083934-01A2 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

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