Study Results
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Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2011-12-31
2013-03-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Weight Reduction Intervention
Weight Reduction Intervention
The weight trial intervention components were:
* Electronic feedback from the ADAPT interactive obesity treatment approach (iOTA) system, tracking participants' behavior change goals. Participants received feedback either by daily SMS (text messaging) or by weekly IVR (interactive automated calls).
* Seven behavior change coaching calls, once a month for 6 months, and then one at 7.5 months halfway through the maintenance period.
* Print mailings/emailings
* 3 Get Ready e-messages in the four weeks before the weight intervention began
* Pedometers and program guides. (IVR users received printed activity logs with their program guides.)
* Access to the ADAPT iOTA website for reviewing their progress and obtaining information on behavior change goals.
Weight Reduction Control Arm
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.
Tested for diabetes
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.
Not tested for diabetes
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.
Interventions
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Weight Reduction Intervention
The weight trial intervention components were:
* Electronic feedback from the ADAPT interactive obesity treatment approach (iOTA) system, tracking participants' behavior change goals. Participants received feedback either by daily SMS (text messaging) or by weekly IVR (interactive automated calls).
* Seven behavior change coaching calls, once a month for 6 months, and then one at 7.5 months halfway through the maintenance period.
* Print mailings/emailings
* 3 Get Ready e-messages in the four weeks before the weight intervention began
* Pedometers and program guides. (IVR users received printed activity logs with their program guides.)
* Access to the ADAPT iOTA website for reviewing their progress and obtaining information on behavior change goals.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
18 Years
FEMALE
No
Sponsors
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Harvard Pilgrim Health Care
OTHER
Duke University
OTHER
Harvard Vanguard Medical Associates
OTHER
Social & Scientific Systems Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Susan J Griffey, DPh, BSN
Role: PRINCIPAL_INVESTIGATOR
Social & Scientific Systems Inc.
Locations
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Social & Scientific Systems Inc.
Silver Spring, Maryland, United States
Countries
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References
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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.
Other Identifiers
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GS10F0381L
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NDEP-GDM GS10F0381L
Identifier Type: -
Identifier Source: org_study_id