Avoiding Diabetes After Pregnancy Trial

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:

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.

Conditions

• Weight Reduction

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Harvard Pilgrim Health Care

  collaborator OTHER

• Duke University

  collaborator OTHER

• Harvard Vanguard Medical Associates

  collaborator OTHER

• Social & Scientific Systems Inc.

  lead INDUSTRY

Principal Investigators

• Susan J Griffey, DPh, BSN · Social & Scientific Systems Inc.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• United States

Study Locations