NCT01734655

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 3, 2016

Completed
Last Updated

July 25, 2017

Status Verified

June 1, 2017

Enrollment Period

2.1 years

First QC Date

November 20, 2012

Results QC Date

July 20, 2015

Last Update Submit

June 22, 2017

Conditions

Outcome Measures

Primary Outcomes (6)

  • Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)

    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

    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

    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

    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

    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

    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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Apolzan JW, Myers CA, Cowley AD, Brady H, Hsia DS, Stewart TM, Redman LM, Martin CK. Examination of the reliability and validity of the Mindful Eating Questionnaire in pregnant women. Appetite. 2016 May 1;100:142-51. doi: 10.1016/j.appet.2016.02.025. Epub 2016 Feb 12.

Related Links

Results Point of Contact

Title
Dr. Corby K. Martin
Organization
Pennington Biomedical Research Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director Ingestive Behavior Laboratory

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 28, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 25, 2017

Results First Posted

March 3, 2016

Record last verified: 2017-06

Locations