Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

NCT01809431 | Completed DMC

• 2 other identifiers: 12-04861R21DK092750-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether a 14 week intervention is successful in improving outcomes for women with gestational diabetes mellitus and their infants.

Conditions

Gestational Diabetes

Keywords

gestational diabetes; women; infants; blood glucose; weight; adiposity; health behaviors; self-efficacy

Outcome Measures

Primary Outcomes (2)

• fasting blood glucose

  Change in fasting blood glucose in mothers

  Baseline to 10 months postpartum

• weight (body mass index)

  Change in weight (body mass index)in mothers

  Baseline to 10 months postpartum

Secondary Outcomes (11)

• oral glucose tolerance test

  Baseline to 10 months postpartum

• insulin levels

  Baseline to 10 months postpartum

• homeostasis model assessment

  Baseline to 10 months postpartum

• hemoglobin A1c

  Baseline to 10 months postpartum

• complete lipid panel

  Baseline to 10 months postpartum

Study Arms (2)

intervention

EXPERIMENTAL

Breastfeeding, progression to type 2 diabetes, nutrition, and exercise education, coping skills training, exercise training, a home-based exercise program and educational and motivational text messaging.

Behavioral: Intervention

Wait-listed control group

NO INTERVENTION

Wait-listed control group receive usual care delivered by their health care provider and after completion of their time in the study they are offered the intervention

Interventions

Intervention BEHAVIORAL

Using a two-group, repeated measures experimental design, this proposed study will test a 14-week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise education, coping skills training, and physical activity (Phase I) and 3 months of continued monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy.

Also known as: breastfeeding education, progression to prediabetes and type 2 diabetes education, nutrition education, exercise education, coping skills training, exercise training, home-based exercise program, educational and motivational text messaging

intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 22-36 weeks of pregnancy who are diagnosed with GDM
• A diagnosis of GDM during the current pregnancy by two or more 100g Oral Glucose Tolerance Test (OGTT) values exceeding established thresholds (fasting 95, 1h 180, 2h 155, 3h 140 mg/dL)
• Age 18-45 years old
• A pre-pregnancy body mass index \> 25kg/m2
• Ability to read and write in English
• Willingness to consent for themselves and their infant

You may not qualify if:

• They have a A1c ≥ 6.5 mg/dL (Type 2 diabetes)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

UNC-Rex Health Care

Raleigh, North Carolina, 27607, United States

Location

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Related Publications (2)

• Stuebe AM, Bonuck K, Adatorwovor R, Schwartz TA, Berry DC. A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes. Breastfeed Med. 2016 Dec;11(10):504-513. doi: 10.1089/bfm.2016.0069. Epub 2016 Oct 26.

  PMID: 27782758 DERIVED

• Berry DC, Neal M, Hall EG, Schwartz TA, Verbiest S, Bonuck K, Goodnight W, Brody S, Dorman KF, Menard MK, Stuebe AM. Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study. BMC Pregnancy Childbirth. 2013 Oct 10;13:184. doi: 10.1186/1471-2393-13-184.

  PMID: 24112417 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Body Weight; Obesity; Health Behavior

Interventions

Methods; Nutrition Assessment; Exercise

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Diane Berry, PhD, ANP-BC

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Alison Stuebe, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2013
• First Posted: March 12, 2013
• Study Start: May 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 13, 2024

Record last verified: 2015-06

Locations

US (2)