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OpenTrials
Completed

NCT Number: NCT01668316

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.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Greensboro

Greensboro, North Carolina, 27402, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss

Behavioral
  • 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.

Primary outcomes

  1. Weight loss and change in body composition

    Time frame: 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 outcomes

  1. Cholesterol

    Time frame: 12 weeks

    We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Greensboro

Other

Registry information

Acronym: GEM

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2012
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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