Recent GDM Lifestyle Intervention

NCT01910805 | Completed DMC

• 1 other identifier: 108628
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Women with a history of gestational diabetes (GDM) have a substantially increased risk of developing type 2 diabetes. In fact, 50-70% of these women will go on to develop type 2 diabetes within the 20 years following their GDM-complicated pregnancy. Perceived risk of developing type 2 diabetes among women with a history of GDM may be particularly important to altering behavior changes associated with reducing risk. Certain populations have lower perceived risk of developing type 2 diabetes, despite having a higher prevalence of the disease. Specifically, African-Americans have a lower perceived risk of developing type 2 diabetes compared to whites, despite their more than doubled risk of developing the disease. Improvement in awareness of diabetes risk among African-American women at high-risk of developing type 2 diabetes, such as those with a history of GDM, could reduce future risk of this disease among this group. As such, we will conduct a two-armed, pilot randomized controlled trial to evaluate whether a postpartum diabetes education intervention, incorporating nutrition, exercise, and diabetes risk assessment can improve diabetes risk awareness, diet, and physical activity levels at 1-year post-pregnancy among African-American women with a recent history of gestational diabetes. We hypothesize that attendance at a 3-month and 9-month postpartum diabetes education class will:

1. 1.Improve diabetes awareness as measured using the Risk Perception for Developing Diabetes among women in the intervention group compared to women in the control group when measuring at 3-months postpartum compared to 12-months postpartum
2. 2.Improve dietary habits and physical activity levels in the intervention group compared to the control group when measuring at 3-months postpartum compared to 12-months postpartum

Conditions

Diabetes Mellitus; Diabetes, Gestational

Keywords

Gestational diabetes; Diabetes mellitus; diabetes in pregnancy; diabetes risk; diabetes risk awareness; African-American; Women

Outcome Measures

Primary Outcomes (1)

• Change in Diabetes Risk Awareness from baseline to 12 months postpartum

  Using an adapted version of the Risk Perception Survey for Developing Diabetes for women with a history of gestational diabetes, women will be asked to respond on web-based or paper questionnaires regarding their individual and group risk of getting diabetes. The primary outcome will measure the change in their awareness of diabetes based on their diabetes risk perception score at baseline (3 months postpartum) compared to 12 months postpartum.

  3-12 months postpartum

Secondary Outcomes (2)

• Change in diet patterns from baseline to 12 months postpartum

  3 months to 12 months postpartum

• Change in physical activity levels from baseline to 12 months postpartum

  3 to 12 months postpartum

Other Outcomes (6)

• Change in diabetes risk awareness from baseline to 9 months

  3 months to 9 months postpartum

• Change in diet patterns from baseline to 9 months postpartum

  3 months to 9 months postpartum

• Change in physical activity levels from baseline to 9 months postpartum

  3 months to 9 months postpartum

Study Arms (2)

Lifestyle and Risk Awareness class

EXPERIMENTAL

Women will attend a 3- and 9-month postpartum group nutrition and physical activity education class.

Behavioral: Lifestyle and Risk Assessment class

Standard Care

NO INTERVENTION

Women will receive standard postpartum care for gestational diabetes mellitus.

Interventions

Lifestyle and Risk Assessment class BEHAVIORAL

Classes will be conducted by a CITI-certified Boston Public Health Commission nutritionist, who is a consultant on this project and has previously worked within the Boston African-American community to increase diabetes awareness and reduce diabetes risk. These classes will be held at a local community center to provide maximal accessibility to the women. The intervention group will attend classes mentioned at the aforementioned centers. Each class will take 2-hours and be conducted by a CITI-certified registered nutritionist with extensive knowledge of working in the African-American community. Both classes will include a cooking demonstration. In addition, the class will include a tour of a local supermarket to aid women in identifying healthy food choices.

Lifestyle and Risk Awareness class

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have gestational diabetes during current or most recent pregnancy
• Be less than 3 months postpartum
• Age between \>=18 years
• Preconception BMI \<45
• Singleton pregnancy
• Self-identified Black/African-American race/ethnicity
• Speak English

You may not qualify if:

• Preexisting diabetes or diabetes diagnosed at the 6 week 75 gram oral glucose tolerance test.
• BMI \>=45.
• Multiple gestation (i.e. twins, triplets, etc.)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tamarra James-Todd, PhD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Epidemiologist

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 30, 2013
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)