The Blossom Project: "Be-Well" Behavioral Wellness Study in Pregnancy (Be-Well)
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|ClinicalTrials.gov Identifier: NCT02168647|
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Excessive Weight Gain in Pregnancy With Baby Delivered||Behavioral: Behavioral Lifestyle counseling Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Blossom Project: "Be Well" Behavioral Wellness Study in Pregnancy to Prevent Excessive Gestational Weight Gain|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Behavioral Lifestyle counseling
Intervention group participants will take part in behavioral lifestyle counseling provided by a Registered Dietitian Nutritionist from week 14 of gestation through childbirth.
Behavioral: Behavioral Lifestyle counseling
Participants in the intervention group will take part in one-on-one visits with a registered dietitian nutritionist (RDN) from no later than week 14 to child birth at the OBGYN clinic where the participant receives her routine prenatal care or the Nutrition Wellness Research Center in the Iowa State Research Park. These visits will be coordinated with her routine prenatal appointment; therefore a minimum of 6 face-to-face meetings will occur. The counseling sessions will focus on appropriate weight gain during pregnancy through the use of an individualized meal plan, physical activity goals, and behavioral modification. Weight gain will be plotted on an IOM weight gain chart and discussed with study RDN.
Active Comparator: Control
Participants in the control arm will receive no form of lifestyle intervention.
Participants in the control arm will receive no form of lifestyle intervention. Women will be provided with usual care by their physician. Participants in the control arm will have their weight gain plotted on an IOM growth chart and sent electronically by research staff after each routine prenatal appointment. No other feedback on weight gain or behavior modification will be provided by the study RDN.
- Maternal Body Weight Change [ Time Frame: From 14 weeks of gestation through 2 months post partum ]
Gestational weight gain as measured by last pre-delivery weight minus self-reported pre-pregnancy weight.
Maternal weight will be measured at each routine prenatal appointment and plotted on the IOM pregnancy weight gain chart.
Body composition changes measured by BodPod at baseline and 2 months postpartum.
- Maternal Postpartum Depression and Perceived Quality of Life [ Time Frame: Baseline through 2 months post partum ]
World Health Organization Quality of Life questionnaire that measure physical health, psychological health, social relationships and environment.
The Edinburg Postnatal Depression Scale
- Maternal Insulin Resistance [ Time Frame: Maternal 26th-28th week of gestation ]Plasma glucose concentrations and insulin resistance as measured from a oral glucose tolerance test.
- Postpartum Weight Retention [ Time Frame: From 14 weeks of gestation through 2 months post partum ]The difference between the weight at 2 months postpartum and the pre-pregnancy weight.
- Infant Outcomes [ Time Frame: 2 months post partum ]
Characteristics at birth including Apgar score, gestational age.
Body composition (i.e. length, percent lean and fat mass) 2 months postpartum.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168647
|United States, Iowa|
|Iowa State University|
|Ames, Iowa, United States, 50011|
|Principal Investigator:||Christina Campbell, Ph.D.||Iowa State University|