Get Active and Eat Right: Moms at Work (GEM)

This study is currently recruiting participants.
Verified August 2012 by University of North Carolina, Greensboro
Sponsor:
Information provided by (Responsible Party):
Cheryl A Lovelady, PhD RD, University of North Carolina, Greensboro
ClinicalTrials.gov Identifier:
NCT01668316
First received: August 3, 2012
Last updated: August 14, 2012
Last verified: August 2012

August 3, 2012
August 14, 2012
July 2012
October 2013   (final data collection date for primary outcome measure)
Weight loss and change in body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01668316 on ClinicalTrials.gov Archive Site
Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.
Same as current
Not Provided
Not Provided
 
Get Active and Eat Right: Moms at Work
Get Active and Eat Right: Moms at Work

The purpose of this study is to determine the effectiveness of a worksite diet and exercise program on weight loss in postpartum women.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Obesity
Behavioral: Weight loss
  1. 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.
  2. 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.
  3. Participants will meet with the research staff every other week to measure weight, waist and hip circumference, and record the steps from the pedometer.
  4. Participants will be encouraged to breastfeed their baby and provided with resources for pumping breast milk at work.
  • Experimental: Weight loss
    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.
    Intervention: Behavioral: Weight loss
  • No Intervention: Control
    Participants asked to not change dietary and physical activity habits.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
Not Provided
October 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Elyse Shearer, MS 336-256-1090 e_sheare@uncg.edu
United States
 
NCT01668316
GEM-12-0059
Not Provided
Cheryl A Lovelady, PhD RD, University of North Carolina, Greensboro
University of North Carolina, Greensboro
Not Provided
Principal Investigator: Cheryl Lovelady, PhD University of North Carolina, Greensboro
University of North Carolina, Greensboro
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP