Pregnancy Clinical Trial
Official title:
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.
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.
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Completed |
NCT02520687 -
Effects of Dietary Nitrate in Hypertensive Pregnant Women
|
Phase 1 |