Weight ReductionADAPTNCT01923350
Avoiding Diabetes After Pregnancy Trial
A study testing Weight Reduction Intervention, Tested for diabetes and Not tested for diabetes in people with Weight Reduction, run by Social & Scientific Systems Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Weight Reduction
- What is being tested?
- Weight Reduction Intervention, Tested for diabetes and Not tested for diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- General:
- Diabetes diagnosis
- Psychotic disorder diagnosis
- Enrolled in a research study
- Weight Reduction Group
- Taking prescription medications for weight loss
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Social & Scientific Systems Inc.
Silver Spring, Maryland, 20910
About this study
Official title: Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
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.
Read more
There were two hypotheses:
- 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.
- 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.
- Conditions
- Weight Reduction
- Being tested
- Weight Reduction Intervention, Weight Reduction Control Arm, Tested for diabetes, Not tested for diabetes
- Keywords
- Weight reduction, Behavioral intervention, Gestational diabetes mellitus, Type 2 diabetes, Diabetes testing
- Medical subject headings
- Weight Loss, Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Reduction InterventionBehavioural
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 ArmBehavioural
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 diabetesBehavioural
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 diabetesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight Reduction Intervention | Experimental | Not described Receives: Behavioral: Weight Reduction Intervention |
| Weight Reduction Control Arm | Active comparator | Not described Receives: Behavioral: Weight Reduction Control Arm |
| Tested for diabetes | Active comparator | Not described Receives: Behavioral: Tested for diabetes |
| Not tested for diabetes | Active comparator | Not described Receives: Behavioral: Not tested for diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
For participants in weight group, weight reduction from baseline to 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.
Measured: 6 months
In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period
The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.
Measured: 6 months
Secondary outcomes (4)
Weight intervention participant engagement with the interactive technology-based supports
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).
Measured: 9 months
Success of participants in weight intervention arm in achieving behavior change goals.
Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores.
Measured: 9 months
Weight change from baseline to 9 months
Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.
Measured: 9 months
Weight change from 6 to 9 months
Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Social & Scientific Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harvard Pilgrim Health Care, Duke University, Harvard Vanguard Medical Associates
- Responsible party
- Sponsor
- Investigators
- Susan J Griffey, DPh, BSN, Principal investigator, Social & Scientific Systems Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923350
- Sponsor's protocol ID
- NDEP-GDM GS10F0381L
- Other IDs
- GS10F0381L
- Acronym
- ADAPT
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24886128
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01923350
- Acronym / sponsor ID
- ADAPT / NDEP-GDM GS10F0381L
- Conditions
- Weight Reduction
- Keywords
- Weight reduction, Behavioral intervention, Gestational diabetes mellitus, Type 2 diabetes, Diabetes testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Social & Scientific Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- Harvard Pilgrim Health Care, Duke University, Harvard Vanguard Medical Associates
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Weight Reduction Intervention | Experimental | Behavioral: Weight Reduction Intervention |
| Weight Reduction Control Arm | Active comparator | Behavioral: Weight Reduction Control Arm |
| Tested for diabetes | Active comparator | Behavioral: Tested for diabetes |
| Not tested for diabetes | Active comparator | Behavioral: Not tested for diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- Diabetes diagnosis
- Psychotic disorder diagnosis
- Enrolled in a research study
- Weight Reduction Group
- Taking prescription medications for weight loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Reduction InterventionThe 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. | Behavioural | Weight Reduction Intervention |
| Weight Reduction Control ArmParticipants 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. | Behavioural | Weight Reduction Control Arm |
| Tested for diabetesDue 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. | Behavioural | Tested for diabetes |
| Not tested for diabetesDue 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. | Behavioural | Not tested for diabetes |
Primary outcome
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.
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.
4 secondary outcomes
Weight intervention participant engagement with the interactive technology-based supports
Time frame: 9 months
Success of participants in weight intervention arm in achieving behavior change goals.
Time frame: 9 months
Weight change from baseline to 9 months
Time frame: 9 months
Weight change from 6 to 9 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Derived from this study: PubMed 24886128Paez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Griffey, DPh, BSN principal investigator
Social & Scientific Systems Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Reduction Intervention, Tested for diabetes and Not tested for diabetes in people with Weight Reduction, run by Social & Scientific Systems Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For participants in weight group, weight reduction from baseline to 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01923350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2013.