An interventional study of Weight Reduction Intervention and Weight Reduction Control Arm in Weight Reduction, sponsored by Social & Scientific Systems Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-15.
Sponsored by Social & Scientific Systems Inc. · Not applicable, Interventional, and Prevention
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:
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's enrollment of 140 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →This is the only study on the registry with Social & Scientific Systems Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
General
Weight Reduction Group
Diabetes Testing Group
Exclusion Criteria:
General:
Weight Reduction Group
Diabetes Testing Group
Behavioral: Weight Reduction Intervention
Behavioral: Weight Reduction Control Arm
Behavioral: Tested for diabetes
Behavioral: Not tested for diabetes
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.
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.
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.
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
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.
Time frame: 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.
Time frame: 6 months
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).
Time frame: 9 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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