Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-31 @ 1:13 AM
Study NCT ID:
NCT01923350
Status:
COMPLETED
Last Update Posted:
2013-08-15
First Post:
2013-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avoiding Diabetes After Pregnancy Trial
Sponsor:
Social & Scientific Systems Inc.
Organization:
Study Overview
Official Title:
Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT
Brief Summary:
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:
1. 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.
2. 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.
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:
1. 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.
2. 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| GS10F0381L | OTHER_GRANT | GSA | View |