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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
History of Changes
  Purpose

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


Condition Intervention
Overweight
Obesity
 Behavioral: Weight loss

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Get Active and Eat Right: Moms at Work

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Greensboro:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 78
Study Start Date: July 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
No Intervention: Control
Participants asked to not change dietary and physical activity habits.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668316

Contacts
Contact: Elyse Shearer, MS 336-256-1090 e_sheare@uncg.edu

Locations
United States, North Carolina
University of North Carolina at Greensboro Recruiting
Greensboro, North Carolina, United States, 27402
Contact: Cheryl Lovelady, PhD     336-256-0310     calovela@uncg.edu    
Sponsors and Collaborators
University of North Carolina, Greensboro
Investigators
Principal Investigator: Cheryl Lovelady, PhD University of North Carolina, Greensboro
  More Information

No publications provided

Responsible Party: Cheryl A Lovelady, PhD RD, Professor, University of North Carolina, Greensboro
ClinicalTrials.gov Identifier: NCT01668316     History of Changes
Other Study ID Numbers: GEM-12-0059
Study First Received: August 3, 2012
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Greensboro:
Overweight
Obese
Postpartum
Weight loss
 Inflammation
Obesity
Cardiovascular

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013