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Study of the Validity of Using the MEQ to Measure Mindful Eating in Pregnant Women (MEQ)

22. juni 2017 opdateret af: Corby K. Martin, Pennington Biomedical Research Center

Qualitative Evaluation of the Mindful Eating Questionnaire (MEQ) in Pregnant Women

The Specific Aim of this supplemental project is to evaluate the Mindful Eating Questionnaire (MEQ) to determine if it is a valid instrument for pregnant women. During this project, the MEQ will be qualitatively evaluated in a sample of pregnant women who are similar in age, ethnicity, education, and marital status to the women targeted for recruitment in the parent study. The qualitative evaluation will include a focus group with 10 participants followed by 30 individual cognitive interviews. Comments from the interviews will be summarized and analyzed systematically for each of the 28 questions of the MEQ and the interviewer will use findings from initial interviews to inform subsequent interviews. Content validity will be evaluated based on responses from the focus group and cognitive interviews, and MEQ items will be evaluated for comprehension, retrieval, judgment, and response. Strengths, weaknesses, relevance, comprehensiveness, and interpretations will be reported for each of the MEQ questions. We will also have some of the more traditional validation parameters (the inclusion of other questionnaires) in the study to collect data on convergent and discriminant validity. The resulting publication will provide readers with a thorough report on the utility and appropriateness of using the MEQ to quantify mindful eating in pregnant women.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Pre-pregnancy maternal overweight/obesity and excess weight gain during pregnancy are associated with metabolic abnormalities in mothers and their offspring. Despite guidelines developed by the Institute of Medicine (IOM) for appropriate levels of gestational weight gain, more than 50% of overweight and obese pregnant women exceed the recommended amount of weight gain during pregnancy (CDC 2009). Updated guidelines from the Institute of Medicine (IOM) in 2009 suggest that individualized dietary counseling and regular physical activity are necessary for pregnant women to achieve appropriate levels of gestational weight gain (IOM and NRC 2009), yet few studies have examined weight management in overweight pregnant women and none were successful at increasing adherence to the IOM guidelines (Polley, Wing et al. 2002; Olson, Strawderman et al. 2004; Asbee, Jenkins et al. 2009; Shirazian, Monteith et al. 2010; Phelan, Phipps et al. 2011).

This project is a supplement to a parent study called Expecting Success: Personalized management of body weight during pregnancy (U01 DK094418-01 PIs: Leanne M. Redman, Ph.D. & Corby K. Martin, Ph.D.). The parent study will test the efficacy of two interventions at promoting appropriate levels of weight gain during pregnancy compared to each other and to a usual care control group. Appropriate levels of weight gain during pregnancy will be defined by the 2009 IOM gestational weight gain guidelines (CDC 2009). The two interventions include training on mindfulness surrounding eating, hunger, and satiety; hence, it is logical to test if changes in mindfulness differ between the two intervention groups and the usual care group. Moreover, it is possible that change in mindfulness will be associated with the study's outcome or different levels of gestational weight gain between the usual care group and the two intervention groups. Finally, changes in mindfulness could mediate the effect of the two interventions on gestational weight gain.

Despite the possible importance of mindfulness to the eating behavior and weight management of pregnant women, no measure has been validated to measure mindfulness in pregnant women. The Mindful Eating Questionnaire (MEQ) is a 28-item self-report instrument that measures five domains of mindful eating: disinhibition, awareness, external cues, emotional response, and distraction. Mindful eating refers to an unbiased awareness of sensations surrounding eating and although a preliminary study found the MEQ to be a valid measure of mindful eating in healthy adults, it has not been validated in pregnant women. A valid measure of mindful eating is required when an intervention is used to increase mindful eating in pregnant women and evaluate if the increase results in healthier eating habits and effective weight management. Indeed, effectively measuring mindful eating is central to evaluating: 1) if an intervention had the anticipated effect on mindful eating, 2) if increasing mindful eating resulted in changes to eating habits and body mass, and 3) if changes in mindful eating mediated treatment effects.

Relationship of the supplement to the parent grant: Mindfulness training is effective at helping people manage their eating habits, making mindfulness training a viable strategy to use with special populations who struggle with eating and weight management, including pregnant women. During the parent study, two personal weight-management interventions designed to meet the unique needs of pregnant women will be deployed and mindful eating techniques are part of these interventions. Although a preliminary study found the Mindful Eating Questionnaire (MEQ) to be valid in a convenience sample of generally healthy adults, it is not known if the MEQ is an appropriate and valid instrument for use with pregnant women, and the proposed project will answer this question. If the MEQ is valid for use with pregnant women, it can be used in the parent study, as well as other studies, to determine if the interventions are effectively at training participant to mindfully eat and if changes in mindful eating mediate intervention effects.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

40

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Pennington Biomedical Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Forty pregnant women (11 will participate in the focus group and 29 will complete individual cognitive interviews) will be recruited who are similar in age, ethnicity, education, and marital status to the women who will be recruited for the parent study.

Beskrivelse

Inclusion Criteria:

  • 18-40 years of age, inclusive
  • Overweight or obese at time of conception based on self-report (BMI ≥25 and <40 kg/m2)
  • Willingness to participate in either the focus group or the individual interview
  • Establish prenatal care by 12 weeks of gestation
  • Fluent in the English language; AND
  • Singleton pregnancy

Exclusion Criteria:

  • Current multiple gestation
  • Type I diabetes
  • Self-reported gestational diabetes mellitus
  • History or current psychotic disorder
  • Current major depressive episode, bipolar disorder, or eating disorder
  • HIV
  • Current smoking, alcohol or drug use
  • History of ≥ 3 miscarriages
  • Current enrollment in Expecting Success (IRB#11024)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
All Participants
Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)
Tidsramme: SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits
Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.
SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits
To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a
Tidsramme: V1
Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a "high" value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency).
V1
Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
Tidsramme: V1
The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.
V1
Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
Tidsramme: V1
The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.
V1
Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
Tidsramme: V1
The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.
V1
Correlation of the MEQ Subscales to the MAAS
Tidsramme: V1
The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level
V1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

20. november 2012

Først indsendt, der opfyldte QC-kriterier

27. november 2012

Først opslået (Skøn)

28. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PBRC 12013
  • U01DK094418 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Graviditet

  • King's College Hospital NHS Trust
    European Association for the Study of the Liver
    Rekruttering
    Cirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of Pregnancy
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