Get Active and Eat Right: Moms at Work

Obesity Clinical Trial

— GEM  

Official title:

Get Active and Eat Right: Moms at Work

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668316
• Other study ID #: GEM-12-0059
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 21, 2015

Study information

• Verified date: April 2019
• Source: University of North Carolina, Greensboro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 21, 2015
• Est. primary completion date: December 21, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina at Greensboro	Greensboro	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	Cholesterol	We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.	12 weeks