ObesitySustain-DPPNCT03500640

Reducing Cardiometabolic Risk and Promoting Functional Health in Older Adults With Obesity and Prediabetes

A study testing DPP Intensive: 30-minute calls and DPP Support: 15-minute calls in people with Obesity and PreDiabetes, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Obesity, PreDiabetes, Aging
What is being tested?: DPP Intensive: 30-minute calls and DPP Support: 15-minute calls
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 314 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2018to 1 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men and women
Ages 60 and older
Body mass index (BMI) >= 27 kg/m2
Prediabetes defined as Hemoglobin (HbA1c) >= 5.7 % and <= 6.4 % or fasting glucose of >= 100 mg/dL and less than 126 mg/dL (at either screening or baseline visit)
Access to a telephone (for group calls) and to video-player or computer with Internet (to watch session videos and activity videos)
Able to travel to one of the community clinics in Southwestern Pennsylvania to participate in the first four in-person intervention sessions and five health assessments at 0, 6, 12, 18, and 24 months
Has health care provider permission to participate

Who cannot join

Currently diagnosed with diabetes (defined as HbA1c of >= 6.5% at either screening or baseline visit)
Currently taking glucose lowering medications or weight loss medications
Weight loss of 9 pounds or more in the last six months
History of bariatric surgery within the last 2 years
Permanently confined to wheelchair
Significant cognitive or psychiatric disability that would preclude participation in normal community-based educational activities

Trial locations and contacts

1 site in 1 country.

United States1 site

Univ. Pittsburgh School of Medicine-Dept. Psychiatry
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Reducing Cardiometabolic Risk and Promoting Functional Health in Community-based Elders With Obesity and Pre-diabetes: Evaluating Sustainable DPP Follow-up Strategies

Obesity and pre-diabetes threatens the overall health and functional independence of older adults but lifestyle weight management for diabetes prevention, soon to be reimbursed by Medicare, can reduce this burden. The current 24-month study will enroll adults, ages 60 and older, through senior community centers and research registries. The investigators will study how two long term weight loss maintenance programs, both using group telephone sessions to support health behavior change, impact meaningful health outcomes. If successful, this project will provide a sustainable intervention model for healthy aging services that can benefit older adults and society.

Read the detailed description

The confluence of obesity and pre-diabetes in older adults increases the risk of diabetes, and accelerates functional decline, chronic disease, disability, and death. More research is needed to refine and extend preventive interventions to reduce burden for vulnerable individuals and society. For over a decade efficacious 6- and 12-month Diabetes Prevention Program (DPP) lifestyle interventions have been translated successfully and shown positive impact. However, efforts to develop and evaluate scalable programs conforming to current guidelines for longer term DPP interventions (up to 24 months), which are consistent with a chronic care model, and help a greater proportion of enrollees sustain the recommended weight loss target of ≥ 5% are lacking. The scientific premise is that evaluation of translational DPP interventions, which has centered largely on strategies for weight loss induction, must be extended to include scalable longer-term interventions that show meaningful weight, cardiometabolic and functional health benefits for vulnerable older adults in community-based settings. A previous DPP-based study from this group of investigators documented the utility of telephone follow-up after 12-weeks of DPP weight loss induction and demonstrated that 63% of the 65-80-year-old volunteer sample with obesity and other risk factors were able to sustain ≥ 5% weight loss at 12-months. Despite good evidence that longer duration lifestyle interventions yield better outcomes (reflected in the latest Medicare ruling) there are no translational studies of 24-month long DPP-based interventions for older adults exclusively. The investigators will recruit participants from a broad array of community settings and examine how best to sustain the impact of a healthy lifestyle-healthy aging focused DPP with scalable treatment components over a 24-month period. The Sustain-DPP study will recruit and enroll adults 60 years of age and older, with overweight/obesity (BMI >= 27) and pre-diabetes (either HbA1c of 5.7 to 6.4% inclusive or fasting glucose >=100 but less than 126 mg/dL) (N = 360) from a network of community centers that offer healthy aging services and from community research registries. The intervention program sequence has been designed to align with current Medicare guidelines. First, from 0-6 months, experienced lifestyle coaches will administer a combination of in-person, video and telephone coaching sessions for all participants, at least 25% from ethnic/racial minority groups. Next, individual participants will be randomized (N = 180 per arm; stratified by weight loss of < or ≥ 5% and other demographic factors) to one of two 18-month follow-up conditions delivered as once-a-month telephone sessions only from 6-24 months. The investigators will compare the effects of (1) 30-minute behavioral intervention sessions, which include a Medicare-DPP and healthy lifestyle for healthy aging focus, and (2) 15-minute social support sessions, on measures of weight (the primary outcome) at 12-, 18-, and 24-months. In addition, data will be collected on cardiometabolic, physical activity, physical function, psychosocial, behavioral and other age-sensitive quality of life measures at 12- and 18- and 24-months. Finally, Medicare claims data will be examined for a proportion of the sample regarding medication use, outpatient, inpatient, and emergency visits and enrollment/participation in elder-focused activity programs. This work, if successful, will have immediate potential for DPP-sustainable lifestyle interventions that benefit vulnerable aging individuals and society.

Conditions: Obesity, PreDiabetes, Aging
Being tested: DPP Intensive: 30-minute calls, DPP Support: 15-minute calls
Keywords: Intervention, Prevention, Weight Management, Physical Activity, Physical Function
Medical subject headings: Obesity, Prediabetic State, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DPP Intensive: 30-minute callsBehavioural
Also called Behavior Change/Relapse Prevention/Healthy Aging
Ongoing DPP intervention and behavioral progress review to prevent relapse and improve cardiometabolic and functional health targets as keys to healthy aging.
DPP Support: 15-minute callsBehavioural
Also called Social Support
No further behavioral intervention materials provided; phone-contacts for mutual social support and accountability

Study groups in NCT03500640
Study group	Role	What they receive
DPP Plus 30-minute calls	Active comparator	Following the 6-month, 16-session, DPP core program, 30-minute group telephone calls will be implemented. Structured behavioral DPP maintenance sessions with a healthy aging focus occur once-per-month from months 7 to 12, and every-two-months from months 13 to 24. Receives: Behavioral: DPP Intensive: 30-minute calls
DPP Minimal 15-minute calls	Placebo comparator	Following the 6-month, 16-session, DPP core program, 15-minute group telephone calls will be implemented. Social-support sessions occur once-per-month from months 7 to 12, and every-two-months from months 13 to 24. Receives: Behavioral: DPP Support: 15-minute calls

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Bodyweight
Percent bodyweight change (clinic measured) of participant
Measured: 12-month change from baseline bodyweight
Change in Bodyweight
Percent bodyweight change (clinic measured) of participant
Measured: 18-month change from baseline bodyweight
Change in Bodyweight
Percent bodyweight change (clinic measured) of participant.
Measured: 24-month change from baseline bodyweight

Secondary outcomes (22)

Change in Waist Circumference
Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.
Measured: 12-month.change from baseline waist circumference
Change in Waist Circumference
Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.
Measured: 24-month change from baseline waist circumference
Change in Fasting Glucose
Fasting glucose (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory.
Measured: 12-month change from baseline fasting glucose
Change in Fasting Glucose
Fasting glucose (mg/dL) blood samples will be taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens are analyzed at a central research laboratory.
Measured: 24-month change from baseline fasting glucose
Change in Fasting Insulin
Fasting insulin blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory. All collected data values obtained will be converted for uniformity to pmol/L.
Measured: 12-month change from baseline fasting insulin
Change in Fasting Insulin
Fasting insulin blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory. All collected data values obtained will be converted for uniformity to pmol/L.
Measured: 24-month change from baseline fasting insulin
Change in Hemoglobin (HbA1c)
HbA1c (percent) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory
Measured: 12-month change from baseline fasting HbA1c
Change in Hemoglobin (HbA1c)
HbA1c (percent) blood samples will be taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens are analyzed at central research laboratory
Measured: 24-month change from baseline fasting HbA1c
Change in Total Cholesterol
Fasting total cholesterol (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory.
Measured: 12-month change from baseline fasting total cholesterol
Change in Total Cholesterol
Fasting total cholesterol (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory.
Measured: 24-month change from baseline fasting total cholesterol
Change in High-density Lipoprotein (HDL)
Fasting HDL (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory.
Measured: 12-month change from baseline fasting HDL
Change in High-density Lipoprotein (HDL)
Fasting HDL (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory.
Measured: 24-month change from baseline fasting HDL
Change in Low-density Lipoprotein (LDL)
Fasting LDL (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory.
Measured: 12-month change from baseline fasting LDL
Change in Low-density Lipoprotein (LDL)
Fasting LDL (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens are analyzed at a central research laboratory.
Measured: 24-month change from baseline fasting LDL
Change in Triglycerides
Fasting triglycerides (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens are analyzed at a central research laboratory.
Measured: 12-month change from baseline fasting triglycerides
Change in Triglycerides
Fasting triglycerides (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens are analyzed at a central research laboratory.
Measured: 24-month change from baseline fasting triglycerides at 24 months
Change in Systolic Blood Pressure (SBP)
SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Measured: 12-month change from baseline SBP
Change in Systolic Blood Pressure (SBP)
SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Measured: 24-month change from baseline SBP
Change in Diastolic Blood Pressure (DBP)
DBP blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Measured: 12-month change from baseline DBP
Change in Diastolic Blood Pressure (DBP)
DBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Measured: 24-month change from baseline DBP.
Change in Physical Function
Short Physical Performance Battery total score (0-12) includes three function tests (each scored 0-4) and summed.
The subtests are (1) gait speed measured in meters/second on a 4-meter walk route; (2) 3 progressive standing balance tests; (3) 5 chair stands.
Change in Total Score is reported here. Higher score indicates better physical function.
Measured: 12-month change from baseline on total score
Change in Physical Function
Short Physical Performance Battery total score (0-12) includes three function tests (each scored 0-4) and summed.
The subtests are (1) gait speed measured in meters/second on a 4-meter walk route; (2) 3 progressive standing balance tests; (3) 5 chair stands.
Change in Total Score is reported here. Higher score indicates better physical function.
Measured: 24-month change from baseline total score

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 20181 May 2023

First posted18 Apr 2018
Study start27 Mar 2018
Primary completion27 Jan 2023
Study completion1 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
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: An initial 16-session Diabetes Prevention Program (DPP), called Group Lifestyle Balance (GLB) and aligned with current Medicare guidelines, will be administered to all enrolled participants primarily through group telephone contact, videos, and workbooks. Subsequently one-half of those enrolled will be randomly assigned to either (1) 30-minute DPP behavior intervention group telephone contact, or (2) 15-minute support group telephone contact for a total of 18 additional follow up months.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 314 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03500640
Sponsor's protocol ID: PRO17060604
Other IDs: R01DK114115
Acronym: Sustain-DPP
Status last verified: Mar 2025
First submitted: 26 Mar 2018
Last updated: 28 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Investigators will follow the guidance of NIDDK on data preparation and sharing policies and insure there is permission to disclose de-identified individual participant-level data collected prior to releasing it to other researchers. In addition, requesting researchers must meet all NIDDK access requirements. Study investigators will maintain strict compliance with Human Research Protections/IRB requirements and use appropriate safeguards before sharing any IPD with other researchers. Within 3 years following final data collection, the investigators will prepare and share the final, completely de-identified dataset (IPD) with NIDDK to be made available to other researchers. However, the investigators will not share other statistical code or data dictionaries.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Cardiometabolic Risk and Promoting Functional Health in Community-based Elders With Obesity and Pre-diabetes: Evaluating Sustainable DPP Follow-up Strategies
ClinicalTrials.gov ID: NCT03500640
Acronym / sponsor ID: Sustain-DPP / PRO17060604
Conditions: Obesity, PreDiabetes, Aging
Keywords: Intervention, Prevention, Weight Management, Physical Activity, Physical Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 314 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 27 Mar 2018 (actual)
Primary completion: 27 Jan 2023 (actual)
Study completion: 1 May 2023 (actual)
First posted: 18 Apr 2018 (actual)
Results: Posted 15 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: An initial 16-session Diabetes Prevention Program (DPP), called Group Lifestyle Balance (GLB) and aligned with current Medicare guidelines, will be administered to all enrolled participants primarily through group telephone contact, videos, and workbooks. Subsequently one-half of those enrolled will be randomly assigned to either (1) 30-minute DPP behavior intervention group telephone contact, or (2) 15-minute support group telephone contact for a total of 18 additional follow up months.

Arm	Type	Receives
DPP Plus 30-minute calls	Active comparator	Behavioral: DPP Intensive: 30-minute callsFollowing the 6-month, 16-session, DPP core program, 30-minute group telephone calls will be implemented. Structured behavioral DPP maintenance sessions with a healthy aging focus occur once-per-month from months 7 to 12, and every-two-months from months 13 to 24.
DPP Minimal 15-minute calls	Placebo comparator	Behavioral: DPP Support: 15-minute callsFollowing the 6-month, 16-session, DPP core program, 15-minute group telephone calls will be implemented. Social-support sessions occur once-per-month from months 7 to 12, and every-two-months from months 13 to 24.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Men and women
Ages 60 and older
Body mass index (BMI) >= 27 kg/m2
Prediabetes defined as Hemoglobin (HbA1c) >= 5.7 % and <= 6.4 % or fasting glucose of >= 100 mg/dL and less than 126 mg/dL (at either screening or baseline visit)
Access to a telephone (for group calls) and to video-player or computer with Internet (to watch session videos and activity videos)

Key exclusion criteria (6 listed)

Currently diagnosed with diabetes (defined as HbA1c of >= 6.5% at either screening or baseline visit)
Currently taking glucose lowering medications or weight loss medications
Weight loss of 9 pounds or more in the last six months
History of bariatric surgery within the last 2 years
Permanently confined to wheelchair

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
DPP Intensive: 30-minute callsAlso: Behavior Change/Relapse Prevention/Healthy AgingOngoing DPP intervention and behavioral progress review to prevent relapse and improve cardiometabolic and functional health targets as keys to healthy aging.	Behavioural	DPP Plus 30-minute calls
DPP Support: 15-minute callsAlso: Social SupportNo further behavioral intervention materials provided; phone-contacts for mutual social support and accountability	Behavioural	DPP Minimal 15-minute calls

Primary outcome

Change in Bodyweight
Time frame: 12-month change from baseline bodyweight
Percent bodyweight change (clinic measured) of participant
Change in Bodyweight
Time frame: 18-month change from baseline bodyweight
Percent bodyweight change (clinic measured) of participant
Change in Bodyweight
Time frame: 24-month change from baseline bodyweight
Percent bodyweight change (clinic measured) of participant.

22 secondary outcomes

Change in Waist Circumference
Time frame: 12-month.change from baseline waist circumference
Change in Waist Circumference
Time frame: 24-month change from baseline waist circumference
Change in Fasting Glucose
Time frame: 12-month change from baseline fasting glucose
Change in Fasting Glucose
Time frame: 24-month change from baseline fasting glucose
Change in Fasting Insulin
Time frame: 12-month change from baseline fasting insulin
Change in Fasting Insulin
Time frame: 24-month change from baseline fasting insulin
Change in Hemoglobin (HbA1c)
Time frame: 12-month change from baseline fasting HbA1c
Change in Hemoglobin (HbA1c)
Time frame: 24-month change from baseline fasting HbA1c
Change in Total Cholesterol
Time frame: 12-month change from baseline fasting total cholesterol
Change in Total Cholesterol
Time frame: 24-month change from baseline fasting total cholesterol
Change in High-density Lipoprotein (HDL)
Time frame: 12-month change from baseline fasting HDL
Change in High-density Lipoprotein (HDL)
Time frame: 24-month change from baseline fasting HDL
Change in Low-density Lipoprotein (LDL)
Time frame: 12-month change from baseline fasting LDL
Change in Low-density Lipoprotein (LDL)
Time frame: 24-month change from baseline fasting LDL
Change in Triglycerides
Time frame: 12-month change from baseline fasting triglycerides
Change in Triglycerides
Time frame: 24-month change from baseline fasting triglycerides at 24 months
Change in Systolic Blood Pressure (SBP)
Time frame: 12-month change from baseline SBP
Change in Systolic Blood Pressure (SBP)
Time frame: 24-month change from baseline SBP
Change in Diastolic Blood Pressure (DBP)
Time frame: 12-month change from baseline DBP
Change in Diastolic Blood Pressure (DBP)
Time frame: 24-month change from baseline DBP.
Change in Physical Function
Time frame: 12-month change from baseline on total score
Change in Physical Function
Time frame: 24-month change from baseline total score

Results and safety

Results posted to the registry on 15 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DPP Core Program	314	258
DPP Plus: 30 Minute Calls	0	0
DPP Minimal: 15-Minute Calls	0	0

Primary outcome: Change in Bodyweight

Time frame: 12-month change from baseline bodyweight. Mean (95% Confidence Interval). Unit: percentage of bodyweight change

Measure	Active Comparator: DPP Plus 30-minute Calls n = 95	Placebo Comparator: DPP Minimal 15-minute Calls n = 84
Value	-7.4 (-8.9 to -5.9)	-6.1 (-7.4 to -4.7)

Active Comparator: DPP Plus 30-minute Calls vs Placebo Comparator: DPP Minimal 15-minute Calls: p = 0.196, t-test, 2 sided

Population analysed: 129 participants were randomized to the Active Comparator and 129 were randomized to the Placebo Comparator at 6-months. Although self-reported weights were obtained, the analytic sample here is ONLY for those with objective clinic measured bodyweight data. This was available for 95 (74%) of Active Comparator and 84 (65%) of the Placebo Comparator arms at 12-months.

Primary outcome: Change in Bodyweight

Time frame: 18-month change from baseline bodyweight. Mean (95% Confidence Interval). Unit: percent bodyweight change

Measure	Active Comparator: DPP Plus 30-minute Calls n = 93	Placebo Comparator: DPP Minimal 15-minute Calls n = 74
Value	-6.4 (-8.0 to -4.7)	-6.1 (-7.7 to -4.4)

Active Comparator: DPP Plus 30-minute Calls vs Placebo Comparator: DPP Minimal 15-minute Calls: p = 0.800, t-test, 2 sided

Population analysed: 129 participants were randomized to the Active Comparator and 129 were randomized to the Placebo Comparator at 6-months. Although self-reported weights were obtained, the analytic sample here is ONLY for those with objective clinic measured bodyweight data. Of these, clinic measured bodyweight data was available for 93 (72%) of Active Comparator and 74 (57%) of the Placebo Comparator arms at 18-months.

Primary outcome: Change in Bodyweight

Time frame: 24-month change from baseline bodyweight. Mean (95% Confidence Interval). Unit: percent bodyweight change

Measure	Active Comparator: DPP Plus 30-minute Calls n = 65	Placebo Comparator: DPP Minimal 15-minute Calls n = 60
Value	-4.6 (-6.2 to -3.1)	-5.1 (-6.8 to -3.4)

Active Comparator: DPP Plus 30-minute Calls vs Placebo Comparator: DPP Minimal 15-minute Calls: p = 0.677, t-test, 2 sided

Population analysed: 129 participants were randomized to the Active Comparator and 129 were randomized to the Placebo Comparator at 6-months. Although self-reported weights were obtained, the analytic sample here is ONLY for those with objective clinic measured bodyweight data. Of these, clinic measured bodyweight data was available for 65 (50%) of the Active Comparator and 60 of Placebo Comparator (46.5%) arms at 24-months.

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious (SAE) and non-serious (AE) adverse event data were collected over the full study period of 24 months as reported to either independent assessment staff at the regular follow-up visits or ad-hoc to intervention staff at the time of phone conferences.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DPP Core Program	2 of 314 (0.6%)	23 of 314 (7.3%)	0 of 314
Active Comparator: DPP Plus 30-minute Calls	2 of 129 (1.6%)	8 of 129 (6.2%)	1 of 129
Placebo Comparator: DPP Minimal 15-minute Calls	4 of 129 (3.1%)	6 of 129 (4.7%)	0 of 129

Limitations and caveats (from the sponsor): The study is likely underpowered for the primary outcome of weight change, due to recruitment targets not being met during the Covid-19 pandemic and greater than expected loss to follow-up for objective measurements in clinic (starting March 2020).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Investigators will follow the guidance of NIDDK on data preparation and sharing policies and insure there is permission to disclose de-identified individual participant-level data collected prior to releasing it to other researchers. In addition, requesting researchers must meet all NIDDK access requirements. Study investigators will maintain strict compliance with Human Research Protections/IRB requirements and use appropriate safeguards before sharing any IPD with other researchers. Within 3 years following final data collection, the investigators will prepare and share the final, completely de-identified dataset (IPD) with NIDDK to be made available to other researchers. However, the investigators will not share other statistical code or data dictionaries.

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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.

Elizabeth M Venditti, PhD principal investigator

Univ. Pittsburgh School of Medicine-Dept. Psychiatry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DPP Intensive: 30-minute calls and DPP Support: 15-minute calls in people with Obesity and PreDiabetes, run by University of Pittsburgh 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 6 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 28 Mar 2025. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Bodyweight (time frame: 12-month change from baseline bodyweight). The study lists 3 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 NCT03500640.

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 28 Mar 2025.