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The Blossom Project: "Be-Well" Behavioral Wellness Study in Pregnancy (Be-Well)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168647
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
LBuckingham, Iowa State University

Brief Summary:
Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. The aim of this study is to provide a lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent excessive gestational weight gain, decrease postpartum weight retention, and improve mental well-being compared to "usual care" using a randomized controlled design in pregnant women. Participants in the intervention group will receive behavioral lifestyle counseling and take part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week 14 of their pregnancy to child birth. Participants in the "usual care" group (control) will not receive any lifestyle counseling. Data collected from this group will be used to compare the effectiveness of the lifestyle intervention. Unlike many studies examining diet and physical activity factors alone, this study evaluates additional psychosocial factors such as psychological health, self-efficacy, competence, motivation and barriers that may influence excessive gestational weight gain. In addition, the Self-Determination Theory framework will be used to measure how motivation and motivational interviewing strategies can help explain changes in volitional behavior.

Condition or disease Intervention/treatment Phase
Excessive Weight Gain in Pregnancy With Baby Delivered Behavioral: Behavioral Lifestyle counseling Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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.
Other: Control
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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


  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women between the ages of 18-45 with a pre-pregnancy BMI between 18.5-35.0 kg/m2 will be recruited for this study.
  • Qualified pregnant women include those participating in a low-active or sedentary lifestyle defined as <3 30-minute exercise sessions per week and therefore, are not currently meeting physical activity guidelines during pregnancy.
  • Participants will need to have qualification criteria confirmed by their medical provider prior to beginning the first data collection period.

Exclusion Criteria:

  • Pregnant beyond 14 weeks gestation
  • Multiple fetuses
  • History of smoking during pregnancy
  • History of gestational diabetes mellitus, pre-eclampsia, or chronic disease (e.g. Type 1 diabetes, Type 2 diabetes, heart disease, renal disease, or untreated thyroid conditions)
  • Inability to comprehend the information shared during the informed consent process
  • Any adverse reactions to armband monitors (e.g. metal allergies, electromagnetic devices)

Information from the National Library of Medicine

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


Locations
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United States, Iowa
Iowa State University
Ames, Iowa, United States, 50011
Sponsors and Collaborators
Iowa State University
Investigators
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Principal Investigator: Christina Campbell, Ph.D. Iowa State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LBuckingham, Dr. Christina Campbell, Associate Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT02168647    
Other Study ID Numbers: 14-199
14-199 ( Other Identifier: Iowa State University Institutional Review Board )
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Keywords provided by LBuckingham, Iowa State University:
Excessive gestational weight gain
Insulin resistance
Physical activity
Behavioral prenatal lifestyle intervention
Reduced carbohydrate intake
Self-determination theory
Motivational interviewing
Additional relevant MeSH terms:
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Weight Gain
Gestational Weight Gain
Body Weight
Body Weight Changes