Clinical trial NCT01734655: Study of the Validity of Using the MEQ to Measure Mindful Eating in Pregnant Women
Official title: Qualitative Evaluation of the Mindful Eating Questionnaire (MEQ) in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-11-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)
timeFrame: SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits
measure: To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a
timeFrame: V1
measure: Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
timeFrame: V1
measure: Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
timeFrame: V1
measure: Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
timeFrame: V1
measure: Correlation of the MEQ Subscales to the MAAS
timeFrame: V1
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: 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.