Avoiding Diabetes After Pregnancy Trial (ADAPT)

Social & Scientific Systems

Status: Completed

Conditions: Weight Reduction

Treatments: Behavioral: Tested for diabetes; Behavioral: Weight Reduction Intervention; Behavioral: Not tested for diabetes; Behavioral: Weight Reduction Control Arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01923350

NDEP-GDM GS10F0381L

GS10F0381L (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

Weight Reduction Intervention

Experimental group

Treatment:

Behavioral: Weight Reduction Intervention

Weight Reduction Control Arm

Active Comparator group

Treatment:

Behavioral: Weight Reduction Control Arm

Tested for diabetes

Active Comparator group

Treatment:

Behavioral: Tested for diabetes

Not tested for diabetes

Active Comparator group

Treatment:

Behavioral: Not tested for diabetes