PreDiabetesPDNCT05395377
Preventing Diabetes
A study testing Registered Dietitian/Nutritionist, Diabetes Prevention Program and Weight Watchers, Reimagined in people with PreDiabetes, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of this project is to improve the quality of weight management care for patients with pre-diabetes and overweight or obesity. Personalized risk profiles, clinical decision support, and patient-centered decision tools for understanding pre-diabetes risk and the likelihood of preventing diabetes with a… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Registered Dietitian/Nutritionist, Diabetes Prevention Program and Weight Watchers, Reimagined
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2017to 16 Nov 2021
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least two weight measures within the last two 24 months, including most recent, that meet the following criteria:
- Prediabetes and BMI >27: Treatment Option 1, 2, 3, or 4
- Prediabetes and BMI >40: Treatment Options 1-5
- Most recent laboratory value that meets prediabetes indicators, per American Diabetes Association, 2016
- Hemoglobin A1C ≥5.7% and <6.5%, or
- Fasting plasma glucose ≥100 mg/dl and <126 mg/dl, or
- Oral glucose tolerance test ≥140 mg/dl and <200 mg/dl
Who cannot join
- History of significant weight loss documented within 5 years,
- Contraindications to weight change (e.g., cancer, pregnancy)
- Prior bariatric surgery
- Weight loss medication use or orders within 5 years prior to the project.
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
Official title: Preventing Diabetes Among Patients With Pre-Diabetes by Improving Patient-Activation and Enhancing Clinical Decision Support for Weight Management to Lower Costs
The purpose of this project is to improve the quality of weight management care for patients with pre-diabetes and overweight or obesity. Personalized risk profiles, clinical decision support, and patient-centered decision tools for understanding pre-diabetes risk and the likelihood of preventing diabetes with a modest 5-7% weight loss will be developed. This project will offer patients their choice of effective weight management treatment options, each containing the cornerstone of weight management- intensive lifestyle intervention. Patients and PCPs will be better informed and equipped with information that helps them make weight management treatment decisions that work the best for their lifestyle, and each is expected to produce at least 5-7% weight loss over 6 months.
Read the detailed description
The primary aim of this study was to demonstrate that an increased recruitment rate for weight loss intervention can be achieved within patients that have pre-diabetes by communicating personalized risk of progression to type 2 diabetes, by estimating risk reduction with weight loss, and by offering program choice. Secondary aims included program participation rate, weight loss, and short term decreased diabetes risk.
- Conditions
- PreDiabetes
- Being tested
- Registered Dietitian/Nutritionist, Diabetes Prevention Program, Weight Watchers, Reimagined, DPP or RDN Counseling + Medication, Bariatric Surgery Evaluation
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registered Dietitian/NutritionistBehavioural
Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.
Diabetes Prevention ProgramBehavioural
Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.
Weight Watchers, ReimaginedBehavioural
Participants in this group were provided with an online access code to enroll in WW and could choose the format of their choice- group, online, and/or smartphone app.
DPP or RDN Counseling + MedicationBehavioural
Participants met with a weight management specialist to receive weight loss medications, as well as, receiving either the DPP or Registered Dietitian coaching. Medications utilized in this study were Phentermine and Metformin. Metformin was prescribed if the participant could not tolerate Phentermine.
Bariatric Surgery EvaluationOther
Participants (BMI > 40) were offered a consultation with the bariatric surgical program that requires lifestyle weight management during the first 6 months. Participants were also able to choose to receive one of the other 4 intervention options in the first six months prior to consideration for bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Registered Dietitian/Nutritionist | Active comparator | Not described Receives: Behavioral: Registered Dietitian/Nutritionist |
| DPP Group Classes | Active comparator | Not described Receives: Behavioral: Diabetes Prevention Program |
| Weight Watchers, Reimagined | Active comparator | Not described Receives: Behavioral: Weight Watchers, Reimagined |
| Pharmacological Treatment | Active comparator | Not described Receives: Behavioral: DPP or RDN Counseling + Medication |
| Bariatric Surgery Evaluation | Active comparator | Not described Receives: Other: Bariatric Surgery Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Race, ethnicity, education level, marital status, household income, and weight management history.
Measured: Baseline
Body Weight
The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up.
Measured: 12 Months
Pre-Diabetes Indicator
At baseline, 6 months,12 months, we will assess HbA1c from the intervention participants. These measures will provide important information about changes in participants' risk and prevention of diabetes.
Measured: 12 months
Patient-Centered Outcomes
Treatment satisfaction and patient involvement in care survey
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start18 Dec 2017
- Primary completion28 Jun 2019
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Model description
- Participants enrolled in this study were able to choose from 1 of 5 intervention options based on their weight status.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Bailey-Davis, DEd, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395377
- Sponsor's protocol ID
- 2017-0394
- Acronym
- PD
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Diabetes Among Patients With Pre-Diabetes by Improving Patient-Activation and Enhancing Clinical Decision Support for Weight Management to Lower Costs
- ClinicalTrials.gov ID
- NCT05395377
- Acronym / sponsor ID
- PD / 2017-0394
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 27 May 2022 (actual)
- 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 purpose of this project is to improve the quality of weight management care for patients with pre-diabetes and overweight or obesity. Personalized risk profiles, clinical decision support, and patient-centered decision tools for understanding pre-diabetes risk and the likelihood of preventing diabetes with a modest 5-7% weight loss will be developed. This project will offer patients their choice of effective weight management treatment options, each containing the cornerstone of weight management- intensive lifestyle intervention. Patients and PCPs will be better informed and equipped with information that helps them make weight management treatment decisions that work the best for their lifestyle, and each is expected to produce at least 5-7% weight loss over 6 months.
Detailed description
The primary aim of this study was to demonstrate that an increased recruitment rate for weight loss intervention can be achieved within patients that have pre-diabetes by communicating personalized risk of progression to type 2 diabetes, by estimating risk reduction with weight loss, and by offering program choice. Secondary aims included program participation rate, weight loss, and short term decreased diabetes risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants enrolled in this study were able to choose from 1 of 5 intervention options based on their weight status.
| Arm | Type | Receives |
|---|---|---|
| Registered Dietitian/Nutritionist | Active comparator | Behavioral: Registered Dietitian/Nutritionist |
| DPP Group Classes | Active comparator | Behavioral: Diabetes Prevention Program |
| Weight Watchers, Reimagined | Active comparator | Behavioral: Weight Watchers, Reimagined |
| Pharmacological Treatment | Active comparator | Behavioral: DPP or RDN Counseling + Medication |
| Bariatric Surgery Evaluation | Active comparator | Other: Bariatric Surgery Evaluation |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least two weight measures within the last two 24 months, including most recent, that meet the following criteria:
- Prediabetes and BMI >27: Treatment Option 1, 2, 3, or 4
- Prediabetes and BMI >40: Treatment Options 1-5
- Most recent laboratory value that meets prediabetes indicators, per American Diabetes Association, 2016
- Hemoglobin A1C ≥5.7% and <6.5%, or
Key exclusion criteria (4 listed)
- History of significant weight loss documented within 5 years,
- Contraindications to weight change (e.g., cancer, pregnancy)
- Prior bariatric surgery
- Weight loss medication use or orders within 5 years prior to the project.
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 |
|---|---|---|
| Registered Dietitian/NutritionistParticipants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist. | Behavioural | Registered Dietitian/Nutritionist |
| Diabetes Prevention ProgramModified DPP group classes lead by a Registered Dietitian and Exercise Physiologist. | Behavioural | DPP Group Classes |
| Weight Watchers, ReimaginedParticipants in this group were provided with an online access code to enroll in WW and could choose the format of their choice- group, online, and/or smartphone app. | Behavioural | Weight Watchers, Reimagined |
| DPP or RDN Counseling + MedicationParticipants met with a weight management specialist to receive weight loss medications, as well as, receiving either the DPP or Registered Dietitian coaching. Medications utilized in this study were Phentermine and Metformin. Metformin was prescribed if the participant could not tolerate Phentermine. | Behavioural | Pharmacological Treatment |
| Bariatric Surgery EvaluationParticipants (BMI > 40) were offered a consultation with the bariatric surgical program that requires lifestyle weight management during the first 6 months. Participants were also able to choose to receive one of the other 4 intervention options in the first six months prior to consideration for bariatric surgery. | Other | Bariatric Surgery Evaluation |
Primary outcome
Demographics
Time frame: Baseline
Race, ethnicity, education level, marital status, household income, and weight management history.
Body Weight
Time frame: 12 Months
The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up.
Pre-Diabetes Indicator
Time frame: 12 months
At baseline, 6 months,12 months, we will assess HbA1c from the intervention participants. These measures will provide important information about changes in participants' risk and prevention of diabetes.
Patient-Centered Outcomes
Time frame: 12 months
Treatment satisfaction and patient involvement in care survey
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 27 May 2022.
- Individual participant dataSharing planned: No
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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.
Lisa Bailey-Davis, DEd principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Registered Dietitian/Nutritionist, Diabetes Prevention Program and Weight Watchers, Reimagined in people with PreDiabetes, run by Geisinger Clinic 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 7 inclusion and 4 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 27 May 2022. 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?
Demographics (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2022.