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Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial (WIP)

Primary Purpose

Obesity, Pregnancy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary and lifestyle counseling
Sponsored by
Carolinas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Pregnancy, Exercise, Nutrition, obesity in pregnancy

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Establish prenatal care at 6 - 16 weeks gestation
  2. 18-49 years of age
  3. Receive their entire prenatal care at the Resident Obstetrics Clinic
  4. English and/or Spanish speaking
  5. Singleton gestation.

Exclusion Criteria:

  1. Establish prenatal care >16 weeks gestation
  2. Non-English or non-Spanish speaking
  3. Multiple gestation pregnancy
  4. BMI > 40
  5. Preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight
  6. Delivery at institution other than CMC-Main
  7. Pregnancy ending in a premature delivery (< 37 weeks)
  8. Limited prenatal care (<4 visits)

Sites / Locations

  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intensive Counseling Group

Routine care group

Arm Description

The routine care group took part in an initial physical exam and history, routine labs, and routine visits per American College of Obstetrics & Gynecology (ACOG) standards. The only counseling on diet and exercise during pregnancy was that included in our standard prenatal booklet "What to do When You're Having a Baby" by Gloria Mayer (Institute for Health Advancement, 2003, La Habra, CA). At each routine obstetric appointment, the participant's weight was measured recorded in the medical chart. The healthcare provider did not counsel the participant regarding any changes in diet or lifestyle.

Outcomes

Primary Outcome Measures

The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.

Secondary Outcome Measures

The investigators secondary outcomes will include the effect of weight gain on mode of delivery, rate of operative vaginal delivery, infant weight, and the incidence of preeclampsia, GDM, vaginal/perineal lacerations, and shoulder dystocia.

Full Information

First Posted
November 14, 2008
Last Updated
November 17, 2008
Sponsor
Carolinas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00792480
Brief Title
Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial
Acronym
WIP
Official Title
Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Terminated
Why Stopped
Resident research project limited by restrictions of residency program.
Study Start Date
October 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Carolinas Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if an organized, consistent program of dietary and lifestyle counseling will prevent excessive gestational weight gain.
Detailed Description
Excessive gestational weight gain is common with about one third of women gaining more weight in pregnancy than is recommended. Unfortunately, the prevalence of excessive gestational weight gain is increasing. Gestational weight gain greater than that recommended by the Institute of Medicine (IOM) is associated with increased risk of gestational complications (hypertension, diabetes, and preeclampsia), infant macrosomia, and complications in delivery including increased risk of cesarean delivery. Currently, there is no evidence-based prenatal counseling protocol available to prevent excessive gestational weight gain. We hypothesize that consistent counseling on appropriate pregnancy diet, weight gain, and the potential complications of excessive gestational weight gain will result in fewer women gaining above the IOM recommendations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pregnancy
Keywords
Obesity, Pregnancy, Exercise, Nutrition, obesity in pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Counseling Group
Arm Type
Experimental
Arm Title
Routine care group
Arm Type
No Intervention
Arm Description
The routine care group took part in an initial physical exam and history, routine labs, and routine visits per American College of Obstetrics & Gynecology (ACOG) standards. The only counseling on diet and exercise during pregnancy was that included in our standard prenatal booklet "What to do When You're Having a Baby" by Gloria Mayer (Institute for Health Advancement, 2003, La Habra, CA). At each routine obstetric appointment, the participant's weight was measured recorded in the medical chart. The healthcare provider did not counsel the participant regarding any changes in diet or lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
Dietary and lifestyle counseling
Intervention Description
The intervention group will undergo a complete history and physical with attention to prepregnancy weight, current weight, height, and BMI. At the initial visit, they will meet with a registered dietician to receive a standardized counseling session, including information on pregnancy-specific dietary and lifestyle choices. The patient will be instructed to engage in moderate intensity exercise at least 3 times per week and preferably 5 times per week. They will also receive information on the appropriate weight gain during pregnancy using the IOM guidelines. Each subject will meet with the dietician only at the time of enrollment. At each routine obstetric appointment, the participant's weight will be measured and charted on an IOM Gestational Weight Gain Grid in front of the participant. The healthcare provider will inform the participant if her weight gain was at the appropriate level and counsel her accordingly regarding increasing or decreasing her intake and exercise.
Primary Outcome Measure Information:
Title
The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.
Time Frame
3 - 6 months
Secondary Outcome Measure Information:
Title
The investigators secondary outcomes will include the effect of weight gain on mode of delivery, rate of operative vaginal delivery, infant weight, and the incidence of preeclampsia, GDM, vaginal/perineal lacerations, and shoulder dystocia.
Time Frame
3 - 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Establish prenatal care at 6 - 16 weeks gestation 18-49 years of age Receive their entire prenatal care at the Resident Obstetrics Clinic English and/or Spanish speaking Singleton gestation. Exclusion Criteria: Establish prenatal care >16 weeks gestation Non-English or non-Spanish speaking Multiple gestation pregnancy BMI > 40 Preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight Delivery at institution other than CMC-Main Pregnancy ending in a premature delivery (< 37 weeks) Limited prenatal care (<4 visits)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelly M Asbee, M.D.
Organizational Affiliation
Lake Norman Ob/Gyn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States

12. IPD Sharing Statement

Citations:
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
derived

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Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial

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