OverweightGEMNCT01668316
Get Active and Eat Right: Moms at Work
A study testing Weight loss in people with Overweight and Obesity, run by University of North Carolina, Greensboro at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 21 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smoking, chronic disease, BMI >35
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Greensboro
Greensboro, North Carolina, 27402
About this study
The purpose of this study is to determine the effectiveness of a worksite diet and exercise program on weight loss in postpartum women.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Weight loss
- Keywords
- Overweight, Obese, Postpartum, Weight loss, Inflammation, Obesity, Cardiovascular
- Medical subject headings
- Overweight, Obesity, Weight Loss, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossBehavioural
- 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 group | Role | What they receive |
|---|---|---|
| Weight loss | Experimental | 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. Receives: Behavioral: Weight loss |
| Control | No intervention | Participants asked to not change dietary and physical activity habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Cholesterol
We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startJul 2012
- Primary completion21 Dec 2015
- Study completion21 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl A Lovelady, PhD RD, University of North Carolina, Greensboro
- Investigators
- Cheryl Lovelady, PhD, Principal investigator, University of North Carolina, Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668316
- Sponsor's protocol ID
- GEM-12-0059
- Acronym
- GEM
- Status last verified
- Apr 2019
- First submitted
- 3 Aug 2012
- Last updated
- 3 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Active and Eat Right: Moms at Work
- ClinicalTrials.gov ID
- NCT01668316
- Acronym / sponsor ID
- GEM / GEM-12-0059
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obese, Postpartum, Weight loss, Inflammation, Obesity, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- 21 Dec 2015 (actual)
- Study completion
- 21 Dec 2015 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss | Experimental | Behavioral: Weight loss12 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. |
| Control | No intervention | –Participants asked to not change dietary and physical activity habits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Smoking, chronic disease, BMI >35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss1. 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. | Behavioural | Weight loss |
Primary outcome
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.
1 secondary outcome
Cholesterol
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Lovelady, PhD principal investigator
University of North Carolina, Greensboro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss in people with Overweight and Obesity, run by University of North Carolina, Greensboro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss and change in body composition (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.