Avoiding Diabetes After Pregnancy Trial
ADAPT
Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
2 other identifiers
interventional
140
1 country
1
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 13, 2013
CompletedFirst Posted
Study publicly available on registry
August 15, 2013
CompletedAugust 15, 2013
August 1, 2013
1.2 years
August 13, 2013
August 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
Weight intervention participant engagement with the interactive technology-based supports
9 months
Success of participants in weight intervention arm in achieving behavior change goals.
9 months
Weight change from baseline to 9 months
9 months
Weight change from 6 to 9 months
3 months
Study Arms (4)
Weight Reduction Intervention
EXPERIMENTALWeight Reduction Control Arm
ACTIVE COMPARATORTested for diabetes
ACTIVE COMPARATORNot tested for diabetes
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- General
- 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
- 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)
You may not qualify if:
- General:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Social & Scientific Systems Inc.lead
- Harvard Pilgrim Health Carecollaborator
- Duke Universitycollaborator
- Harvard Vanguard Medical Associatescollaborator
Study Sites (1)
Social & Scientific Systems Inc.
Silver Spring, Maryland, 20910, United States
Related Publications (1)
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.
PMID: 24886128DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan J Griffey, DPh, BSN
Social & Scientific Systems Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2013
First Posted
August 15, 2013
Study Start
December 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 15, 2013
Record last verified: 2013-08