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- Ensaio Clínico NCT01839708
Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM) (MIM)
27 de abril de 2018 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
569
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Michigan
-
East Lansing, Michigan, Estados Unidos, 48824
- Michigan State University
-
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 39 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
Outros nomes:
|
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Sem intervenção: No Lifestyle Counseling
Comparison group: usual WIC care; read printed materials at home
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measured Body Weight
Prazo: 3 months after the 16-week intervention (T3)
|
measured body weight in person at WIC office
|
3 months after the 16-week intervention (T3)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
T1 Fat Intake
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Immediatly after the 16-week intervention (T2)
|
measured body weight in person at WIC office
|
Immediatly after the 16-week intervention (T2)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mei-Wei Chang, Ph.D, Michigan State University College of Nursing
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2011
Conclusão Primária (Real)
1 de setembro de 2015
Conclusão do estudo (Real)
31 de março de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
28 de fevereiro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de abril de 2013
Primeira postagem (Estimativa)
25 de abril de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de maio de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de abril de 2018
Última verificação
1 de abril de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R18DK083934-01A2 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .