GEM: Get Active and Eat Right: Moms at Work

Sponsor

University of North Carolina, Greensboro (Other)

Overall Status

Completed

CT.gov ID

NCT01668316

Collaborator

(none)

Enrollment

Location

Arms

41.7

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Behavioral: Weight loss	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Get Active and Eat Right: Moms at Work

Actual Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Dec 21, 2015

Actual Study Completion Date :

Dec 21, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 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.
No Intervention: Control Participants asked to not change dietary and physical activity habits.

Arm

Intervention/Treatment

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

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.

No Intervention: Control

Participants asked to not change dietary and physical activity habits.

Outcome Measures

Primary Outcome Measures

Weight loss and change in body composition [12 weeks]
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 [12 weeks]
We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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