Avoiding Diabetes After Pregnancy Trial (ADAPT)

This study has been completed.
Sponsor:
Collaborators:
Harvard Pilgrim Health Care
Duke University
Harvard Vanguard Medical Associates
Information provided by (Responsible Party):
Social & Scientific Systems Inc.
ClinicalTrials.gov Identifier:
NCT01923350
First received: August 13, 2013
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Social & Scientific Systems Inc.:

Primary Outcome Measures:
  • For participants in weight group, weight reduction from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.


Secondary Outcome Measures:
  • Weight intervention participant engagement with the interactive technology-based supports [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.


Enrollment: 140
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weight Reduction Intervention 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.
Active Comparator: Weight Reduction Control Arm 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.
Active Comparator: Tested for 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.
Active Comparator: Not tested for diabetes 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923350

Locations
United States, Maryland
Social & Scientific Systems Inc.
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
Social & Scientific Systems Inc.
Harvard Pilgrim Health Care
Duke University
Harvard Vanguard Medical Associates
Investigators
Principal Investigator: Susan J Griffey, DPh, BSN Social & Scientific Systems Inc.
  More Information

No publications provided by Social & Scientific Systems Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Social & Scientific Systems Inc.
ClinicalTrials.gov Identifier: NCT01923350     History of Changes
Other Study ID Numbers: NDEP-GDM GS10F0381L, GS10F0381L
Study First Received: August 13, 2013
Last Updated: August 14, 2013
Health Authority: United States: Federal Government

Keywords provided by Social & Scientific Systems Inc.:
Weight reduction
Behavioral intervention
Gestational diabetes mellitus
Type 2 diabetes
Diabetes testing

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014