Trial Outcomes & Findings for Study of the Validity of Using the MEQ to Measure Mindful Eating in Pregnant Women (NCT NCT01734655)
NCT ID: NCT01734655
Last Updated: 2017-07-25
Results Overview
Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits
Results posted on
2017-07-25
Participant Flow
Participant milestones
| Measure |
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 in either a focus group format (the first 11 participants) or cognitive interview format (the last 29 participants).
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Validity of Using the MEQ to Measure Mindful Eating in Pregnant Women
Baseline characteristics by cohort
| Measure |
All Participants
n=40 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.
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Age, Continuous
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30 years
STANDARD_DEVIATION 4 • n=93 Participants
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Sex: Female, Male
Female
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40 Participants
n=93 Participants
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Sex: Female, Male
Male
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0 Participants
n=93 Participants
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Region of Enrollment
United States
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40 participants
n=93 Participants
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Pre-pregnancy BMI
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30.0 kg/m2
STANDARD_DEVIATION 4.1 • n=93 Participants
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Pre-pregnancy Body Weight
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83.5 kg
STANDARD_DEVIATION 17.6 • n=93 Participants
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Gestational Age
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19.9 weeks
STANDARD_DEVIATION 8.3 • n=93 Participants
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Current BMI
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31.8 kg/m2
STANDARD_DEVIATION 4.7 • n=93 Participants
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Current Body Weight
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86.5 kg
STANDARD_DEVIATION 14.9 • n=93 Participants
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PRIMARY outcome
Timeframe: SV and V1; minimum of 24 hours between visits, maximum of 5 months between visitsParticipants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.
Outcome measures
| Measure |
Participants
n=40 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.
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Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)
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.85 test-retest coefficent
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PRIMARY outcome
Timeframe: V1Population: Pregnant women who were overweight or obese and 18-40 yrs of age.
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).
Outcome measures
| Measure |
Participants
n=40 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.
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To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a
Disinhibition
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.63 Ratio of Variance
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To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a
Awareness
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.59 Ratio of Variance
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To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a
External Cues
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.31 Ratio of Variance
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To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a
Emotional Response
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.59 Ratio of Variance
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To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a
Distraction
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.68 Ratio of Variance
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PRIMARY outcome
Timeframe: V1Population: Pregnant women who were overweight or obese and 18-40 yrs of age.
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.
Outcome measures
| Measure |
Participants
n=40 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.
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Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
Disinhibition**
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.46 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
Awareness
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.07 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
External Cues
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-.07 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
Emotional Response**
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.48 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
Distraction
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.26 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
Total Score (w ECS)
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.40 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
Total Score (w/o ECS)**
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.46 correlation coefficients
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PRIMARY outcome
Timeframe: V1The 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.
Outcome measures
| Measure |
Participants
n=40 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.
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Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
Disinhibition**
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-.64 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
Awareness
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-.30 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
External Cues
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-.04 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
Emotional Response**
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-.68 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
Distraction
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-.33 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
Total Score (w ECS)**
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-.65 correlation coefficients
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Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
Total Score (w/o ECS)**
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-.70 correlation coefficients
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PRIMARY outcome
Timeframe: V1The 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.
Outcome measures
| Measure |
Participants
n=40 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.
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Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
Disinhibition**
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-.54 correlation coefficients
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Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
Awareness
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-.04 correlation coefficients
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Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
External Cues
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-.01 correlation coefficients
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Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
Emotional Response**
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-.41 correlation coefficients
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Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
Distraction
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-.40 correlation coefficients
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Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
Total Score (w ECS)**
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-.46 correlation coefficients
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Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
Total Score (w/o ECS)**
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-.51 correlation coefficients
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PRIMARY outcome
Timeframe: V1The 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
Outcome measures
| Measure |
Participants
n=40 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.
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Correlation of the MEQ Subscales to the MAAS
Disinhibition**
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.40 correlation coefficients
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Correlation of the MEQ Subscales to the MAAS
Awareness
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.245 correlation coefficients
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Correlation of the MEQ Subscales to the MAAS
External Cues
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.01 correlation coefficients
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Correlation of the MEQ Subscales to the MAAS
Emotional Response**
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.44 correlation coefficients
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Correlation of the MEQ Subscales to the MAAS
Distraction**
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.64 correlation coefficients
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Correlation of the MEQ Subscales to the MAAS
Total Score (w ECS)**
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.58 correlation coefficients
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Correlation of the MEQ Subscales to the MAAS
Total Score (w/o ECS)**
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.63 correlation coefficients
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Adverse Events
All Participants
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=40 participants at risk
Pregnant women who were overweight or obese and 18-40 yrs of age.
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Gastrointestinal disorders
Abdominal Pain
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2.5%
1/40 • Number of events 1
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Pregnancy, puerperium and perinatal conditions
Vaginal Spotting
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2.5%
1/40 • Number of events 1
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Additional Information
Dr. Corby K. Martin
Pennington Biomedical Research Center
Phone: 225-763-2585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place