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NCT Number: NCT01923350

Avoiding Diabetes After Pregnancy Trial

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.

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Key information

Conditions

Weight Reduction Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Weight Loss

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Social & Scientific Systems Inc.

Silver Spring, Maryland, 20910, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Weight Reduction Intervention

Behavioral

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.

Weight Reduction Control Arm

Behavioral

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.

Tested for diabetes

Behavioral

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.

Not tested for diabetes

Behavioral

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.

Primary outcomes

  1. For participants in weight group, weight reduction from baseline to 6 months

    Time frame: 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.

  2. 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

    The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.

Secondary outcomes

  1. Weight intervention participant engagement with the interactive technology-based supports

    Time frame: 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).

  2. Success of participants in weight intervention arm in achieving behavior change goals.

    Time frame: 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.

  3. Weight change from baseline to 9 months

    Time frame: 9 months

    Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.

  4. Weight change from 6 to 9 months

    Time frame: 3 months

    Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.

Sponsors and collaborators

Lead sponsor

Social & Scientific Systems Inc.

Industry

Collaborators

  • Duke University
  • Harvard Pilgrim Health Care
  • Harvard Vanguard Medical Associates

Registry information

Official study title

Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus

Acronym: ADAPT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 15, 2013
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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