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eMOMS of Rochester (eMOMS)

Primary Purpose

Gestational Weight Gain, Postpartum Weight Retention

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

electronic intervention during pregnancy and postpartum

electronic intervention during pregnancy

Control

About this trial

This is an interventional prevention trial for Gestational Weight Gain focused on measuring Pregnancy, Postpartum, Weight gain, Weight retention, Behavior, Electronic Media, Randomized Clinical Trial

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Age 18 - 35 at the time of delivery
Consented at or before 20 weeks gestation
Intending to be available for a 24 months intervention
Plan to deliver in one of the 4 hospitals in Rochester, NY (the study area)
Plan to carry the pregnancy to term
Plan to keep the baby
Read and understand English

Exclusion Criteria:

BMI < 18.5 kg/m2 and > 35.0 kg/m2.
Multiple gestation. If multiple gestation is diagnosed after enrollment participant will be terminated from the study (reasons for termination will be included in the consent form)
Medical conditions prior to pregnancy which could influence weight loss or gain: cystic fibrosis, hyperthyroidism, renal insufficiency1, proteinuria1, cerebral palsy, lupus erythematosus; rheumatoid arthritis, Crohns disease (severity and other autoimmune diseases evaluated case by case), ulcerative colitis, maternal congenital heart disease (patients are often underweight); hypertension treated with medication2,
Psychiatric medication associated with major weight gain or loss (e.g.; Lithium & Divalproex) Common Criteria
Household member on study staff
Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); currently enrolled or planned to enroll in a weight loss or another weight gain prevention study
Participants will be excluded during screening if they report regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected- insulin, metformin, byetta, TZDs, other). "Regular use" is defined as "taking this medication most days of the week for the previous month"
Current treatment for eating disorder
Positive screening for bulimia
Weight loss of more than 15 pounds in the three months prior to pregnancy
Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 month. Revascularization is defined as bypass surgery or stints
Mental or psychiatric condition that precludes giving informed consent and completing questionnaires
Current treatment for malignancy (other than non-melanoma skin cancer and CIN cervix) or on remission for less than 5 years
Blood pressure criterion

Sites / Locations

University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

electronic intervention group 2

electronic intervention group 1

Control

Arm Description

(e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum

(e-intervention 1) receives a behavioral intervention through a website during pregnancy. During the postpartum period this arm receives the same non-weight-related information as the control arm

Outcomes

Primary Outcome Measures

Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms

Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight).

Postpartum weight retention in kg at 12 months postpartum

The difference between the weight at 12 months postpartum and the pre-pregnancy weight (or early pregnancy weight. Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum.

Secondary Outcome Measures

Caloric Intake in Kilocalories

Caloric intake will be calculated based on the average food intake assessed by 2 24-hour dietary recall.

Physical activity as an average weekly energy expenditure (METS)

Physical activity during pregnancy is measured using the Pregnancy Physical Activity Questionnaire and during postpartum using the Global Physical Activity Questionnaire.

Postpartum weight retention at 18 months

The difference between the weight at 18 months postpartum and the prepregnancy weight (or early pregnancy weight). Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum

Full Information

NCT ID

NCT01331564

First Posted

March 31, 2011

Last Updated

November 30, 2015

Sponsor

University of Rochester

Collaborators

Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT01331564

Brief Title

eMOMS of Rochester

Acronym

eMOMS

Official Title

Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

Cornell University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The project aims to develop, implement and evaluate electronically-mediated behavioral intervention programs for pregnant and postpartum women in order to prevent excessive weight gain during pregnancy and postpartum weight retention.

Detailed Description

This study seeks to expand the understanding of how to slow the accumulation of weight in childbearing women. The intervention goals are to decrease the prevalence of excessive pregnancy weight gain and mean weight retention in the first 18 months postpartum in socio-economically and racially/ethnically diverse sample of 1,641 pregnant women. Women will be randomly assigned to one of three groups: Intervention Group 1 will receive the intervention program only during pregnancy (e-intervention 1). Intervention Group 2 will receive e-intervention 1 plus intervention for 18 months postpartum (e-intervention 2). Control women will receive non-weight related content during both time periods at the project website. The primary hypotheses for the randomized controlled trial are: H1: The proportion of women in Intervention Groups 1 and 2 who gain more weight in pregnancy than is recommended by the IOM will be 33% less than the proportion of the women in the Control Group who gain excessively and H2: The Control Group will have a higher mean weight retention at 12 months postpartum than Intervention Groups 1 and 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Weight Gain, Postpartum Weight Retention

Keywords

Pregnancy, Postpartum, Weight gain, Weight retention, Behavior, Electronic Media, Randomized Clinical Trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1641 (Actual)

8. Arms, Groups, and Interventions

Arm Title

electronic intervention group 2

Arm Type

Experimental

Arm Description

(e-intervention 2) receives a behavioral intervention through a website during pregnancy and until 18 months postpartum

Arm Title

electronic intervention group 1

Arm Type

Experimental

Arm Description

(e-intervention 1) receives a behavioral intervention through a website during pregnancy. During the postpartum period this arm receives the same non-weight-related information as the control arm

Arm Title

Control

Arm Type

Placebo Comparator

Intervention Type

Behavioral

Intervention Name(s)

electronic intervention during pregnancy and postpartum

Other Intervention Name(s)

Behavior modification intervention for pregnancy, Behavior modification intervention for postpartum, Prevention of excessive gestational weight gain, Prevention of postpartum weight retention, Electronically-mediated behavioral interventions

Intervention Description

Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy and to follow a healthy lifestyle postpartum to minimize postpartum weight retention

Intervention Type

Behavioral

Intervention Name(s)

electronic intervention during pregnancy

Other Intervention Name(s)

Behavior modification intervention for pregnancy, Prevention of excessive gestational weight gain, Electronically-mediated behavioral interventions

Intervention Description

Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.

Intervention Type

Behavioral

Intervention Name(s)

Control

Other Intervention Name(s)

Control group

Intervention Description

Control women will receive non-weight related content during both time periods at the project website.

Primary Outcome Measure Information:

Title

Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms

Description

Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight).

Time Frame

40 weeks

Title

Postpartum weight retention in kg at 12 months postpartum

Description

Time Frame

1.5 years

Secondary Outcome Measure Information:

Title

Caloric Intake in Kilocalories

Description

Caloric intake will be calculated based on the average food intake assessed by 2 24-hour dietary recall.

Time Frame

2 years

Title

Physical activity as an average weekly energy expenditure (METS)

Description

Physical activity during pregnancy is measured using the Pregnancy Physical Activity Questionnaire and during postpartum using the Global Physical Activity Questionnaire.

Time Frame

2 years

Title

Postpartum weight retention at 18 months

Description

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 - 35 at the time of delivery Consented at or before 20 weeks gestation Intending to be available for a 24 months intervention Plan to deliver in one of the 4 hospitals in Rochester, NY (the study area) Plan to carry the pregnancy to term Plan to keep the baby Read and understand English Exclusion Criteria: BMI < 18.5 kg/m2 and > 35.0 kg/m2. Multiple gestation. If multiple gestation is diagnosed after enrollment participant will be terminated from the study (reasons for termination will be included in the consent form) Medical conditions prior to pregnancy which could influence weight loss or gain: cystic fibrosis, hyperthyroidism, renal insufficiency1, proteinuria1, cerebral palsy, lupus erythematosus; rheumatoid arthritis, Crohns disease (severity and other autoimmune diseases evaluated case by case), ulcerative colitis, maternal congenital heart disease (patients are often underweight); hypertension treated with medication2, Psychiatric medication associated with major weight gain or loss (e.g.; Lithium & Divalproex) Common Criteria Household member on study staff Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); currently enrolled or planned to enroll in a weight loss or another weight gain prevention study Participants will be excluded during screening if they report regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected- insulin, metformin, byetta, TZDs, other). "Regular use" is defined as "taking this medication most days of the week for the previous month" Current treatment for eating disorder Positive screening for bulimia Weight loss of more than 15 pounds in the three months prior to pregnancy Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 month. Revascularization is defined as bypass surgery or stints Mental or psychiatric condition that precludes giving informed consent and completing questionnaires Current treatment for malignancy (other than non-melanoma skin cancer and CIN cervix) or on remission for less than 5 years Blood pressure criterion

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabel D Fernandez, MD, MPH, PhD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christine M Olson, PhD

Organizational Affiliation

Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34088249

Citation

Yu Y, Ma Q, Fernandez ID, Groth SW. Mental Health, Behavior Change Skills, and Eating Behaviors in Postpartum Women. West J Nurs Res. 2022 Oct;44(10):932-945. doi: 10.1177/01939459211021625. Epub 2021 Jun 4.

Results Reference

derived

PubMed Identifier

29743026

Citation

Olson CM, Groth SW, Graham ML, Reschke JE, Strawderman MS, Fernandez ID. The effectiveness of an online intervention in preventing excessive gestational weight gain: the e-moms roc randomized controlled trial. BMC Pregnancy Childbirth. 2018 May 9;18(1):148. doi: 10.1186/s12884-018-1767-4.

Results Reference

derived

PubMed Identifier

28573669

Citation

Olson CM, Strawderman MS, Graham ML. Association between consistent weight gain tracking and gestational weight gain: Secondary analysis of a randomized trial. Obesity (Silver Spring). 2017 Jul;25(7):1217-1227. doi: 10.1002/oby.21873. Epub 2017 Jun 2.

Results Reference

derived

PubMed Identifier

28069560

Citation

Graham ML, Strawderman MS, Demment M, Olson CM. Does Usage of an eHealth Intervention Reduce the Risk of Excessive Gestational Weight Gain? Secondary Analysis From a Randomized Controlled Trial. J Med Internet Res. 2017 Jan 9;19(1):e6. doi: 10.2196/jmir.6644.

Results Reference

derived

PubMed Identifier

25957183

Citation

Fernandez ID, Groth SW, Reschke JE, Graham ML, Strawderman M, Olson CM. eMoms: Electronically-mediated weight interventions for pregnant and postpartum women. Study design and baseline characteristics. Contemp Clin Trials. 2015 Jul;43:63-74. doi: 10.1016/j.cct.2015.04.013. Epub 2015 May 6.

Results Reference

derived

PubMed Identifier

25143156

Citation

Demment MM, Graham ML, Olson CM. How an online intervention to prevent excessive gestational weight gain is used and by whom: a randomized controlled process evaluation. J Med Internet Res. 2014 Aug 20;16(8):e194. doi: 10.2196/jmir.3483.

Results Reference

derived

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