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| ID | Type | Description | Link |
|---|---|---|---|
| GS10F0381L | Other Grant/Funding Number | GSA |
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| Name | Class |
|---|---|
| Harvard Pilgrim Health Care | OTHER |
| Duke University | OTHER |
| Harvard Vanguard Medical Associates | OTHER |
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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:
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:
There was an additional secondary aim involving metformin:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Reduction Intervention | Experimental |
| |
| Weight Reduction Control Arm | Active Comparator |
| |
| Tested for diabetes | Active Comparator |
| |
| Not tested for diabetes | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Reduction Intervention | Behavioral | The weight trial intervention components were:
|
| Measure | Description | Time Frame |
|---|---|---|
| For participants in weight group, weight reduction from baseline to 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. | 6 months |
| In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period | The number of women who were tested in the 6 months following the intervention was determined from electronic medical records. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight intervention participant engagement with the interactive technology-based supports | 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). | 9 months |
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Inclusion Criteria:
General
Weight Reduction Group
Diabetes Testing Group
Exclusion Criteria:
General:
Weight Reduction Group
Diabetes Testing Group
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| Name | Affiliation | Role |
|---|---|---|
| Susan J Griffey, DPh, BSN | Social & Scientific Systems Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Social & Scientific Systems Inc. | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24886128 | Derived | Paez KA, Griffey SJ, Thompson J, Gillman MW. Validation of self-reported weights and heights in the avoiding diabetes after pregnancy trial (ADAPT). BMC Med Res Methodol. 2014 May 13;14:65. doi: 10.1186/1471-2288-14-65. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Weight Reduction Control Arm | Behavioral | 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. |
|
| Tested for diabetes | Behavioral | 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. |
|
| Not tested for diabetes | Behavioral | 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. |
|
| Success of participants in weight intervention arm in achieving behavior change goals. |
Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores. |
| 9 months |
| Weight change from baseline to 9 months | Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group. | 9 months |
| Weight change from 6 to 9 months | Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group. | 3 months |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |