Recent GDM Lifestyle Intervention (LIFe)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01910805|
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : January 12, 2016
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:
- 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
- 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 or disease||Intervention/treatment|
|Diabetes Mellitus Diabetes, Gestational||Behavioral: Lifestyle and Risk Assessment class|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Lifestyle Intervention for African-American Women: A Pilot Study for Women With a Recent History of Gestational Diabetes (The LIFe Study)|
|Study Start Date :||August 2014|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
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.
- Change in Diabetes Risk Awareness from baseline to 12 months postpartum [ Time Frame: 3-12 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.
- Change in diet patterns from baseline to 12 months postpartum [ Time Frame: 3 months to 12 months postpartum ]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 ]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.
- Change in diabetes risk awareness from baseline to 9 months [ Time Frame: 3 months to 9 months postpartum ]
- Change in diet patterns from baseline to 9 months postpartum [ Time Frame: 3 months to 9 months postpartum ]
- Change in physical activity levels from baseline to 9 months postpartum [ Time Frame: 3 months to 9 months postpartum ]
- Change in diabetes risk awareness from baseline to 6 months postpartum [ Time Frame: 3 to 6 months postpartum ]
- Change in diet patterns from baseline to 6 months postpartum [ Time Frame: 3 to 6 months postpartum ]
- Change in physical activity levels from baseline to 6 months postpartum [ Time Frame: 3 to 6 months postpartum ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910805
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Tamarra James-Todd, PhD, MPH||Brigham and Women's Hospital|