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Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy Trial (WEIGHT)

Primary Purpose

Obesity, Pregnancy, Weight Gain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Longitudinal Nutritional Counseling
Standard Care
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Pregnancy, Weight Gain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnancy identified less than 15 week 0 days gestational age
  • Body mass index greater then or equal to 18

Exclusion Criteria:

  • Multiple gestation
  • Pre-pregnancy diabetes mellitus
  • HIV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Longitudinal Nutritional Counseling

    Standard Care Counseling

    Arm Description

    The intervention group will be contacted every 2 weeks by medical students over the phone to provide nutrition counseling and complete a verbal survey. During the phone calls, participants will be asked a series of questions regarding their dietary intake over the course of the last 2 weeks. If any deficiencies are identified, participants will be counseled on those topics

    Participants in the control group will receive standard counseling, which includes weights at every visit, and counseling on weight gain goals as perceived necessary by the provider.

    Outcomes

    Primary Outcome Measures

    Incidence of excessive weight gain
    To compare the effect of a medical student assisted program of nutritional counseling and web based nutrition tracking to standard of care on the incidence of excessive weight gain in pregnancy based on the Institute of Medicine's guidelines.

    Secondary Outcome Measures

    Healthy Eating Habits
    To characterize how a medical student assisted program of nutritional counselling and web based nutrition tracking affects perception of healthy eating habits (e.g servings of dairy, vegetables, protein, healthy meals)
    Pregnancy Comorbidity
    To compare the incidence of maternal outcomes including gestational diabetes, gestational hypertension and preeclampsia for patients receiving nutrition counselling and web based nutrition tracking compared to standard of care controls

    Full Information

    First Posted
    October 10, 2016
    Last Updated
    May 31, 2017
    Sponsor
    Loyola University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02932202
    Brief Title
    Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy Trial
    Acronym
    WEIGHT
    Official Title
    Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy (WEIGHT) Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The trial was stopped due to no recruitment
    Study Start Date
    July 8, 2016 (Actual)
    Primary Completion Date
    May 17, 2017 (Actual)
    Study Completion Date
    May 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Loyola University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counseling. The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.
    Detailed Description
    Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The rates of obesity in American adults is 34.9% and the rates of excessive weight gain in pregnancy for all women range from 20-40% with even higher rates seen in the obese. Such high rates are putting mothers and infants at significant risk.· In 2009, the Institute of Medicine outlined clear guidelines for suggested weight gain goals based on pre-pregnancy BMI. Currently only 30-40% of pregnant women are meeting the suggested weight gain goals and the great majority not meeting the goals are gaining excessive weight. However, despite the high prevalence of excessive weight gain, there is little access to insurance covered nutrition counselling. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counselling. This can be challenging due to limited time and resources. However, there is good evidence that diet intervention reduces the risk of excessive weight gain by up to 20%. If appropriate nutritional counselling were available to all patients, the rates of excessive weight gain could be significantly impacted and have widespread improvement in pregnancy outcomes. The CDC has made important progress in providing free nutrition resources online to all patients. This study aims to incorporate this free resource with a sustainable ongoing nutrition counselling to impact the rates of excessive weight gain in pregnancy. The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Pregnancy, Weight Gain
    Keywords
    Obesity, Pregnancy, Weight Gain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants are randomized to either a medical student assisted program comprising nutritional counselling and web based nutrition tracking methods (i.e., longitudinal nutritional counseling program) or routine follow-up with their primary healthcare specialist (standard of care) using a 1:1 random numbers block allocation
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Longitudinal Nutritional Counseling
    Arm Type
    Experimental
    Arm Description
    The intervention group will be contacted every 2 weeks by medical students over the phone to provide nutrition counseling and complete a verbal survey. During the phone calls, participants will be asked a series of questions regarding their dietary intake over the course of the last 2 weeks. If any deficiencies are identified, participants will be counseled on those topics
    Arm Title
    Standard Care Counseling
    Arm Type
    Placebo Comparator
    Arm Description
    Participants in the control group will receive standard counseling, which includes weights at every visit, and counseling on weight gain goals as perceived necessary by the provider.
    Intervention Type
    Other
    Intervention Name(s)
    Longitudinal Nutritional Counseling
    Intervention Type
    Other
    Intervention Name(s)
    Standard Care
    Primary Outcome Measure Information:
    Title
    Incidence of excessive weight gain
    Description
    To compare the effect of a medical student assisted program of nutritional counseling and web based nutrition tracking to standard of care on the incidence of excessive weight gain in pregnancy based on the Institute of Medicine's guidelines.
    Time Frame
    At time of delivery
    Secondary Outcome Measure Information:
    Title
    Healthy Eating Habits
    Description
    To characterize how a medical student assisted program of nutritional counselling and web based nutrition tracking affects perception of healthy eating habits (e.g servings of dairy, vegetables, protein, healthy meals)
    Time Frame
    At time of delivery
    Title
    Pregnancy Comorbidity
    Description
    To compare the incidence of maternal outcomes including gestational diabetes, gestational hypertension and preeclampsia for patients receiving nutrition counselling and web based nutrition tracking compared to standard of care controls
    Time Frame
    At time of delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pregnancy identified less than 15 week 0 days gestational age Body mass index greater then or equal to 18 Exclusion Criteria: Multiple gestation Pre-pregnancy diabetes mellitus HIV
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Scott Graziano, MD
    Organizational Affiliation
    Loyola University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no individual participant data.
    Citations:
    PubMed Identifier
    24570244
    Citation
    Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
    Results Reference
    background
    PubMed Identifier
    19155899
    Citation
    Asbee SM, Jenkins TR, Butler JR, White J, Elliot M, Rutledge A. Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):305-12. doi: 10.1097/AOG.0b013e318195baef.
    Results Reference
    background

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    Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy Trial

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