Avoiding Diabetes After Pregnancy Trial

Not Applicable

Completed

• Conditions: Weight Reduction
• Interventions: Behavioral: Weight Reduction Intervention; Behavioral: Weight Reduction Control Arm; Behavioral: Tested for diabetes; Behavioral: Not tested for diabetes

• Registration Number: NCT01923350
• Lead Sponsor: Social & Scientific Systems Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-08
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-14
• Last Update Submitted: 2013-08-14
• Study First Posted: 2013-08-15
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight Reduction Intervention	Weight Reduction Intervention	-
Weight Reduction Control Arm	Weight Reduction Control Arm	-
Tested for diabetes	Tested for diabetes	-
Not tested for diabetes	Not tested for diabetes	-

Primary Outcome Measures

Name	Time	Method
For participants in weight group, weight reduction from baseline to 6 months	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.
In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period	6 months	The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.

Secondary Outcome Measures

Name	Time	Method
Weight intervention participant engagement with the interactive technology-based supports	9 months	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).
Success of participants in weight intervention arm in achieving behavior change goals.	9 months	Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores.
Weight change from baseline to 9 months	9 months	Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.
Weight change from 6 to 9 months	3 months	Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.

Trial Locations

Locations (1)

Social & Scientific Systems Inc.; 🇺🇸 Silver Spring, Maryland, United States