eMOMS of Rochester

NCT01331564 | Completed Phase 3 DMC

• 1 other identifier: HL096760
• Study Type: interventional
• Target: 1,641
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Weight Gain; Postpartum Weight Retention

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

  40 weeks

• 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.

  1.5 years

Secondary Outcomes (3)

• Caloric Intake in Kilocalories

  2 years

• Physical activity as an average weekly energy expenditure (METS)

  2 years

• Postpartum weight retention at 18 months

  2 years

Study Arms (3)

electronic intervention group 2

EXPERIMENTAL

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

Behavioral: electronic intervention during pregnancy and postpartum

electronic intervention group 1

EXPERIMENTAL

(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

Behavioral: electronic intervention during pregnancy

Control

PLACEBO COMPARATOR

Behavioral: Control

Interventions

electronic intervention during pregnancy and postpartum BEHAVIORAL

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

Also known as: 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

electronic intervention group 2

electronic intervention during pregnancy BEHAVIORAL

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

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

electronic intervention group 1

Control BEHAVIORAL

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

Also known as: Control group

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Cornell University: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (6)

• 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.

  PMID: 34088249 DERIVED

• 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.

  PMID: 29743026 DERIVED

• 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.

  PMID: 28573669 DERIVED

• 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.

  PMID: 28069560 DERIVED

• 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.

  PMID: 25957183 DERIVED

• 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.

  PMID: 25143156 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain; Weight Gain; Behavior

Interventions

Postpartum Period; Pregnancy; Control Groups

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Reproduction; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Isabel D Fernandez, MD, MPH, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Christine M Olson, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public Health Sciences

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 8, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)