NCT01668316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2015

Completed
Last Updated

May 3, 2019

Status Verified

April 1, 2019

Enrollment Period

3.5 years

First QC Date

August 3, 2012

Last Update Submit

April 30, 2019

Conditions

Keywords

OverweightObesePostpartumWeight lossInflammationObesityCardiovascular

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cholesterol

    12 weeks

Study Arms (2)

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.

Behavioral: Weight loss

Control

NO INTERVENTION

Participants asked to not change dietary and physical activity habits.

Interventions

Weight lossBEHAVIORAL

1. 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.

Weight loss

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smoking, chronic disease, BMI \>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Greensboro

Greensboro, North Carolina, 27402, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight LossInflammation

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesPathologic Processes

Study Officials

  • Cheryl Lovelady, PhD

    University of North Carolina, Greensboro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 20, 2012

Study Start

July 1, 2012

Primary Completion

December 21, 2015

Study Completion

December 21, 2015

Last Updated

May 3, 2019

Record last verified: 2019-04

Locations