Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)

NCT01344278 | Completed DMC

• 1 other identifier: R01HS019367-01
• Study Type: interventional
• Target: 2,480
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to examine the comparative effectiveness of diabetes prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the following conditions: obesity, hyperglycemia, hypertension and depression. This randomized lifestyle intervention study will be conducted at Kaiser Permanente Northern California. Women in the intervention will receive a letter on gestational weight gain during pregnancy and in the postpartum period, a curriculum of individualized lifestyle counseling via telephone, augmented with e-mail and an interactive Web site. Patients randomized to the usual care arm will receive the standard-care telephone calls from the Perinatal Center during pregnancy and the Center's printed educational materials postpartum. Outcomes will be assessed through the electronic medical record and patient surveys conducted during pregnancy and at 6-weeks, 6- months and 1-year postpartum.

Conditions

Gestational Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Primary outcome: meeting the postpartum weight goal

  Will be the proportion of women who reach their postpartum weight goal (based on their pre-pregnancy weight) and the total amount of weight change (in kilograms). Weight goals: a) reaching pre-pregnancy weight if women had a normal pre-pregnancy weight; or b) achieving a 5% reduction from pre-pregnancy weight if overweight or obese prior to pregnancy.

  through 12 months postpartum

Secondary Outcomes (5)

• Blood pressure

  through 12 months postpartum

• Depression

  through 12 months postpartum

• Glycemia

  through 12 months postpartum

• percent of calories from fat

  through 12 months postpartum

• physical activity

  through 12 months postpartum

Study Arms (2)

Lifestyle Counseling

EXPERIMENTAL

Behavioral: Lifestyle Counseling

Control

NO INTERVENTION

Interventions

Lifestyle Counseling BEHAVIORAL

A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.

Lifestyle Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women, 18 years of age or older, receiving medical care at Kaiser Permanente Northern California with a pregnancy complicated by gestational diabetes between March 2011 and May 2012 that have a telephone or cellular phone will be eligible.

You may not qualify if:

• Women with overt diabetes not recognized prior to pregnancy (any women with fasting plasma glucose \> 126 mg/dl, or any plasma glucose level over 200 mg/dl on more than 1 occasion during pregnancy) will be excluded from the analyses but will be eligible for the lifestyle intervention.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Division of Research Northern California

Oakland, California, 94612, United States

Location

Related Publications (4)

• Gadgil MD, Ehrlich SF, Zhu Y, Brown SD, Hedderson MM, Crites Y, Ferrara A. Dietary Quality and Glycemic Control Among Women with Gestational Diabetes Mellitus. J Womens Health (Larchmt). 2019 Feb;28(2):178-184. doi: 10.1089/jwh.2017.6788. Epub 2018 Oct 30.

  PMID: 30376391 DERIVED

• Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Zhu Y, Quesenberry CP, Crites Y, Ferrara A. A Tailored Letter Based on Electronic Health Record Data Improves Gestational Weight Gain Among Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster-Randomized Controlled Trial. Diabetes Care. 2018 Jul;41(7):1370-1377. doi: 10.2337/dc17-1133. Epub 2018 Apr 18.

  PMID: 29669736 DERIVED

• Ferrara A, Hedderson MM, Brown SD, Albright CL, Ehrlich SF, Tsai AL, Caan BJ, Sternfeld B, Gordon NP, Schmittdiel JA, Gunderson EP, Mevi AA, Herman WH, Ching J, Crites Y, Quesenberry CP Jr. The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial. Diabetes Care. 2016 Jan;39(1):65-74. doi: 10.2337/dc15-1254. Epub 2015 Dec 9.

  PMID: 26657945 DERIVED

• Ferrara A, Hedderson MM, Albright CL, Brown SD, Ehrlich SF, Caan BJ, Sternfeld B, Gordon NP, Schmittdiel JA, Gunderson EP, Mevi AA, Tsai AL, Ching J, Crites Y, Quesenberry CP Jr. A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study. BMC Pregnancy Childbirth. 2014 Jan 15;14:21. doi: 10.1186/1471-2393-14-21.

  PMID: 24423410 DERIVED

Related Links

• GEM Trial Publication

MeSH Terms

Conditions

Diabetes, Gestational; Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Assiamira Ferrara, MD, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2015
• Last Updated: April 25, 2016

Record last verified: 2016-04

Locations

US (1)