Clinical trial NCT01923350: Avoiding Diabetes After Pregnancy Trial
Official title: Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Reduction
Keywords: Weight reduction
Behavioral intervention
Gestational diabetes mellitus
Type 2 diabetes
Diabetes testing
Lead sponsor: Social & Scientific Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: Harvard Pilgrim Health Care
name: Duke University
name: Harvard Vanguard Medical Associates
First posted: 2013-08-15
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.


Eligibility criteria: 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)

Primary outcomes:
measure: For participants in weight group, weight reduction from baseline to 6 months
timeFrame: 6 months
measure: In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period
timeFrame: 6 months
Secondary outcomes:
measure: Weight intervention participant engagement with the interactive technology-based supports
timeFrame: 9 months
measure: Success of participants in weight intervention arm in achieving behavior change goals.
timeFrame: 9 months
measure: Weight change from baseline to 9 months
timeFrame: 9 months
measure: Weight change from 6 to 9 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Social & Scientific Systems Inc.
state: Maryland
Study officials:
affiliation: Social & Scientific Systems Inc.
name: Susan J Griffey, DPh, BSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.