Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- For participants in weight group, weight reduction from baseline to 6 months
研究概览
简要总结
The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the effectiveness of interventions that potentially increase the adoption of Diabetes Prevention Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus (GDM).
The study was conducted as an integrated trial with two separate arms: one to facilitate weight reduction and the other to increase diabetes testing.
There were two hypotheses:
- Women in the testing intervention will be more likely to have received a diabetes test within the 6 months post-intervention than women in the control group.
- Women in the weight reduction intervention will have lost more weight at the 6-month and 9-month follow-up than women in the control group.
The primary study aim was to determine the efficacy of a system of interactive technology-based supports to prompt women with a history of gestational diabetes to take steps to prevent diabetes. The secondary aims were focused on women's engagement:
- To evaluate the impact of the weight reduction intervention in terms of participant engagement with the interactive technology-based supports.
- To evaluate changes in the women's perception of their personal diabetes risk following after exposure to information about diabetes risk following a pregnancy with GDM.
- To identify the determinants and motivators of and barriers to diabetes testing in the 6- to 12-week postpartum period and thereafter, using the Health Belief model to guide the study.
There was an additional secondary aim involving metformin:
- To evaluate the impact of the diabetes risk reduction intervention in terms of women seeking out their physician's advice on metformin treatment and receiving a metformin prescription, if appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of GDM in the previous 6 months to 4.5 years
- •Access to the internet and text messages or phone messages
- •Current patient of Harvard Vanguard Medical Associates
- •18 years of age or older
- •Able to read in English
- •Weight Reduction Group
- •Overweight or obese
- •Capable of performing moderate physical activity
- •Diabetes Testing Group
- •Had not competed a diabetes test (OGTT or fasting blood sugar at 6-12 weeks postpartum or OGTT, fasting blood sugar or hemoglobin A1c after 12 weeks postpartum)
排除标准
- •Diabetes diagnosis
- •Psychotic disorder diagnosis
- •Enrolled in a research study
- •Weight Reduction Group
- •Taking prescription medications for weight loss
- •Engaged in a formal weight reduction program
- •Diabetes Testing Group
- •History of postpartum OGTT, fasting plasma glucose or hemoglobin A1c (after 6 weeks postpartum)
结局指标
主要结局
For participants in weight group, weight reduction from baseline to 6 months
时间窗: 6 months
Participants reported their weights online at baseline, 3 months, 6 months, and 9 months, and the difference in weight from baseline to 6 months was the primary measure of the intervention's success.
In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period
时间窗: 6 months
The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.
次要结局
- Weight intervention participant engagement with the interactive technology-based supports(9 months)
- Success of participants in weight intervention arm in achieving behavior change goals.(9 months)
- Weight change from baseline to 9 months(9 months)
- Weight change from 6 to 9 months(3 months)