Recent GDM Lifestyle Intervention (LIFe)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Tamarra James-Todd, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01910805
First received: July 17, 2013
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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. 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. 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

Condition Intervention
Diabetes Mellitus
Diabetes, Gestational
Behavioral: Lifestyle and Risk Assessment class

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lifestyle Intervention for African-American Women: A Pilot Study for Women With a Recent History of Gestational Diabetes (The LIFe Study)

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in Diabetes Risk Awareness from baseline to 12 months postpartum [ Time Frame: 3-12 months postpartum ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in diet patterns from baseline to 12 months postpartum [ Time Frame: 3 months to 12 months postpartum ] [ Designated as safety issue: No ]
    Women will be asked to respond to a adapted food frequency questionnaire. This food frequency questionnaire has been previously used in postpartum populations and is correlated with various health outcomes in observational studies. Diet information will be asked using the same food frequency questionnaire multiple times and the difference between baseline (3 months postpartum) and 12 months postpartum will be measured.

  • Change in physical activity levels from baseline to 12 months postpartum [ Time Frame: 3 to 12 months postpartum ] [ Designated as safety issue: No ]
    Women will be asked to respond to questions regarding their physical activity level using an adapted physical activity questionnaire from the Nurses' Health Study. These questions will be adapted for use in a postpartum, African-American population. Women will be asked about their physical activity levels multiple times and the difference between physical activity levels at baseline (3 months) and at 12 months postpartum will be measured.


Other Outcome Measures:
  • Change in diabetes risk awareness from baseline to 9 months [ Time Frame: 3 months to 9 months postpartum ] [ Designated as safety issue: No ]
  • Change in diet patterns from baseline to 9 months postpartum [ Time Frame: 3 months to 9 months postpartum ] [ Designated as safety issue: No ]
  • Change in physical activity levels from baseline to 9 months postpartum [ Time Frame: 3 months to 9 months postpartum ] [ Designated as safety issue: No ]
  • Change in diabetes risk awareness from baseline to 6 months postpartum [ Time Frame: 3 to 6 months postpartum ] [ Designated as safety issue: No ]
  • Change in diet patterns from baseline to 6 months postpartum [ Time Frame: 3 to 6 months postpartum ] [ Designated as safety issue: No ]
  • Change in physical activity levels from baseline to 6 months postpartum [ Time Frame: 3 to 6 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle and Risk Awareness class
Women will attend a 3- and 9-month postpartum group nutrition and physical activity education class.
Behavioral: Lifestyle and Risk Assessment class

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.

No Intervention: Standard Care
Women will receive standard postpartum care for gestational diabetes mellitus.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Preexisting diabetes or diabetes diagnosed at the 6 week 75 gram oral glucose tolerance test.
  • BMI >=45.
  • Multiple gestation (i.e. twins, triplets, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910805

Contacts
Contact: Tamarra James-Todd, PhD, MPH 617-525-8193 tjames-todd@partners.org
Contact: Audrey Carr, BS 617-732-7078 acarr5@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Tamarra James-Todd, PhD, MPH    617-525-8193    tjames-todd@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Tamarra James-Todd, PhD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Tamarra James-Todd, Associate Epidemiologist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01910805     History of Changes
Other Study ID Numbers: 108628
Study First Received: July 17, 2013
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board
United States: Partners Human Research Committee

Keywords provided by Brigham and Women's Hospital:
Gestational diabetes
Diabetes mellitus
diabetes in pregnancy
diabetes risk
diabetes risk awareness
African-American
Women

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on September 18, 2014