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

Tracking Information

First Received Date ^ICMJE

August 3, 2012

Last Updated Date

August 14, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01668316 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Get Active and Eat Right: Moms at Work

Official Title ^ICMJE

Get Active and Eat Right: Moms at Work

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Overweight
Obesity

Intervention ^ICMJE

Behavioral: Weight loss

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.

Study Arm (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Elyse Shearer, MS

336-256-1090

e_sheare@uncg.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01668316

Other Study ID Numbers ^ICMJE

GEM-12-0059

Has Data Monitoring Committee

Not Provided

Responsible Party

Cheryl A Lovelady, PhD RD, University of North Carolina, Greensboro

Study Sponsor ^ICMJE

University of North Carolina, Greensboro

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Cheryl Lovelady, PhD

University of North Carolina, Greensboro

Information Provided By

University of North Carolina, Greensboro

Verification Date

August 2012

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

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