Avoiding Diabetes After Pregnancy Trial (ADAPT)
|ClinicalTrials.gov Identifier: NCT01923350|
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : August 15, 2013
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.
|Condition or disease||Intervention/treatment|
|Weight Reduction||Behavioral: Weight Reduction Intervention Behavioral: Weight Reduction Control Arm Behavioral: Tested for diabetes Behavioral: Not tested for diabetes|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus|
|Study Start Date :||December 2011|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
|Experimental: Weight Reduction Intervention||
Behavioral: Weight Reduction Intervention
The weight trial intervention components were:
|Active Comparator: Weight Reduction Control Arm||
Behavioral: Weight Reduction Control Arm
Participants received an initial brochure about managing diabetes risk, a digital scale to use in entering their weights in online questionnaires, and monthly emailed wellness messages unrelated to diabetes.
|Active Comparator: Tested for diabetes||
Behavioral: Tested for diabetes
Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a sub-sample of those tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
|Active Comparator: Not tested for diabetes||
Behavioral: Not tested for diabetes
Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a subsample of those not tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
- For participants in weight group, weight reduction from baseline to 6 months [ Time Frame: 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 [ Time Frame: 6 months ]The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.
- Weight intervention participant engagement with the interactive technology-based supports [ Time Frame: 9 months ]Measured by separate scores for taking part in behavioral support (coaching calls) and electronic feedback (women responding on goal performance via daily text messaging (SMS)or weekly IVR, chosen by the participant).
- Success of participants in weight intervention arm in achieving behavior change goals. [ Time Frame: 9 months ]Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores.
- Weight change from baseline to 9 months [ Time Frame: 9 months ]Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.
- Weight change from 6 to 9 months [ Time Frame: 3 months ]Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923350
|United States, Maryland|
|Social & Scientific Systems Inc.|
|Silver Spring, Maryland, United States, 20910|
|Principal Investigator:||Susan J Griffey, DPh, BSN||Social & Scientific Systems Inc.|