Avoiding Diabetes After Pregnancy Trial

Study Overview
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Brief Summary
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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: 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. 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.

Official Title
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Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus

Conditions
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Weight Reduction

Intervention / Treatment
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* Behavioral: Weight Reduction Intervention
* Behavioral: Weight Reduction Control Arm
* Behavioral: Tested for diabetes
* Behavioral: Not tested for diabetes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Reduction Intervention<br> | Behavioral: Weight Reduction Intervention<br>* 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.<br>|
| Active Comparator: Weight Reduction Control Arm<br> | Behavioral: Weight Reduction Control Arm<br>* 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.<br>|
| Active Comparator: Tested for diabetes<br> | Behavioral: Tested for diabetes<br>* 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.<br>|
| Active Comparator: Not tested for diabetes<br> | Behavioral: Not tested for diabetes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight reduction, Behavioral intervention, Gestational diabetes mellitus, Type 2 diabetes, Diabetes testing