- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01839708
Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM) (MIM)
27 april 2018 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
569
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Michigan
-
East Lansing, Michigan, Förenta staterna, 48824
- Michigan State University
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 39 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
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.
Andra namn:
|
Inget ingripande: No Lifestyle Counseling
Comparison group: usual WIC care; read printed materials at home
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Measured Body Weight
Tidsram: 3 months after the 16-week intervention (T3)
|
measured body weight in person at WIC office
|
3 months after the 16-week intervention (T3)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
T1 Fat Intake
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Immediatly after the 16-week intervention (T2)
|
measured body weight in person at WIC office
|
Immediatly after the 16-week intervention (T2)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mei-Wei Chang, Ph.D, Michigan State University College of Nursing
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2011
Primärt slutförande (Faktisk)
1 september 2015
Avslutad studie (Faktisk)
31 mars 2017
Studieregistreringsdatum
Först inskickad
28 februari 2013
Först inskickad som uppfyllde QC-kriterierna
22 april 2013
Första postat (Uppskatta)
25 april 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 april 2018
Senast verifierad
1 april 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1R18DK083934-01A2 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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