Get Active and Eat Right: Moms at Work (GEM)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight, Obese, Postpartum, Weight loss, Inflammation, Obesity, Cardiovascular
Eligibility Criteria
Inclusion Criteria:
- 18 years and older, 10 to 14 weeks postpartum, University faculty, staff, and students, BMI 25-35 or at least 4.5 kilograms heavier than prepregnancy weight, English speaking
Exclusion Criteria:
- Smoking, chronic disease, BMI >35
Sites / Locations
- University of North Carolina at Greensboro
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Weight loss
Control
Arm Description
12 week weight loss program with biweekly meetings with a Registered Dietitian. Participants will be given a nutrition prescription and asked to record dietary intake online. Participants will be given a pedometer and record daily physical activity.
Participants asked to not change dietary and physical activity habits.
Outcomes
Primary Outcome Measures
Weight loss and change in body composition
We will be measuring change in weight, waist and hip circumference, and body fat percentage to assess the degree of weight loss and change in body composition at baseline and after the 12 week intervention.
Secondary Outcome Measures
Cholesterol
We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.
Full Information
NCT ID
NCT01668316
First Posted
August 3, 2012
Last Updated
April 30, 2019
Sponsor
University of North Carolina, Greensboro
1. Study Identification
Unique Protocol Identification Number
NCT01668316
Brief Title
Get Active and Eat Right: Moms at Work
Acronym
GEM
Official Title
Get Active and Eat Right: Moms at Work
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
December 21, 2015 (Actual)
Study Completion Date
December 21, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Greensboro
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of a worksite diet and exercise program on weight loss in postpartum women.
Detailed Description
This project is a research study investigating the effects of a worksite diet and exercise intervention on weight loss in overweight postpartum women. Weight loss programs have been shown to be effective in reducing postpartum weight retention. However, high attrition rates in these studies suggest that the added responsibility of a new infant at home and returning to work may limit a woman's ability to follow a diet plan and exercise regularly. We hope that by offering a weight loss program at the workplace, we can increase participant retention and maximize weight loss in this population. Our primary aim is to promote weight loss while preserving lean body mass during the 12 week intervention. Secondary aims include increasing cardiovascular fitness from baseline and improving cardiovascular biomarkers, including total, LDL, and HDL cholesterol, triglycerides, glucose, insulin, and markers of inflammation and metabolism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obese, Postpartum, Weight loss, Inflammation, Obesity, Cardiovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight loss
Arm Type
Experimental
Arm Description
12 week weight loss program with biweekly meetings with a Registered Dietitian. Participants will be given a nutrition prescription and asked to record dietary intake online. Participants will be given a pedometer and record daily physical activity.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants asked to not change dietary and physical activity habits.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss
Intervention Description
Participants will be prescribed a reduced calorie diet and asked to track their diet three days per week using the online USDA MyPlate SuperTracker. This record will be accessed by the RD in order to provide diet recommendations sent by email.
Participants will be given an exercise prescription, and encouraged to walk briskly with a provided pedometer or exercise at the campus Recreation Center every day. Participants will be asked to record the number of steps and other physical activity in a log book.
Participants will meet with the research staff every other week to measure weight, waist and hip circumference, and record the steps from the pedometer.
Participants will be encouraged to breastfeed their baby and provided with resources for pumping breast milk at work.
Primary Outcome Measure Information:
Title
Weight loss and change in body composition
Description
We will be measuring change in weight, waist and hip circumference, and body fat percentage to assess the degree of weight loss and change in body composition at baseline and after the 12 week intervention.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cholesterol
Description
We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years and older, 10 to 14 weeks postpartum, University faculty, staff, and students, BMI 25-35 or at least 4.5 kilograms heavier than prepregnancy weight, English speaking
Exclusion Criteria:
Smoking, chronic disease, BMI >35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Lovelady, PhD
Organizational Affiliation
University of North Carolina, Greensboro
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27402
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Get Active and Eat Right: Moms at Work
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