Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK114115 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPP Intensive: 30-minute calls | Behavioral | Ongoing DPP intervention and behavioral progress review to prevent relapse and improve cardiometabolic and functional health targets as keys to healthy aging. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bodyweight | Percent bodyweight change (clinic measured) of participant | 12-month change from baseline bodyweight |
| Change in Bodyweight | Percent bodyweight change (clinic measured) of participant | 18-month change from baseline bodyweight |
| Change in Bodyweight | Percent bodyweight change (clinic measured) of participant. | 24-month change from baseline bodyweight |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Waist Circumference | Waist circumference measured in centimeters with a Gulick spring-loaded tape measure. | 12-month.change from baseline waist circumference |
| Change in Waist Circumference |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health Related Quality of Life | Short-form 12-item health status questionnaire (SF-12) produces two scores; a physical component summary score (PCS) and a mental component summary score (MCS). Scores range from 0-100 with higher scores indicating better health related quality of life outcome. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10. Scores below 50 suggest below average perceived health-related quality of life (e.g., a T-Score of 42 is indicative of a clinically relevant threshold for elevated depressive symptoms on the MCS scale). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth M Venditti, PhD | Univ. Pittsburgh School of Medicine-Dept. Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. Pittsburgh School of Medicine-Dept. Psychiatry | Pittsburgh | Pennsylvania | 15213 | United States |
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.
3 years from the final data collection of the last participant
Investigators will share data through the NIDDK central repository (website shown below)
Of 314 participants enrolled, all were offered a base 16-session DPP intervention (0-6 months) through group teleconference contact, videos, and workbooks. Of these, 258 participants were randomized to the two-group teleconference follow-up contact arms. Although the "Period 1" 0-6-month outcomes data will be reported in the final outcomes' manuscript, these pre-randomization data are not intended to be part of the primary or secondary analyses.
After working with key stakeholders in the community, the study start date was March 27, 2018, and recruitment continued through February 2021. Recruitment was conducted in six waves, focusing on public and private senior centers and recreation facilities, senior residences, church ministries, medical practices, and senior/retiree database registries. Methods included in-person presentations, newspaper and digital media blasts, and direct-mail postcards.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DPP Core Program | In Period 1, from 0-6 months, the DPP Core Program was implemented for ALL participants (pre-randomization). The DPP Core Program consisted of the base 16-session DPP intervention delivered through group teleconference contact, self-directed videos, and workbooks |
| FG001 | DPP Plus: 30 Minute Calls | In Periods 2, 3, and 4, DPP Plus: 30-minute calls were implemented (post-randomization). These consisted of structured behavioral DPP maintenance sessions with a healthy aging focus. Sessions occurred once-per-month (7-12 months) then every two months (13-16 months and 18-24 months). The ongoing DPP intervention sessions were designed to be behaviorally intensive and provided behavioral goals review and new learning materials at each contact. |
| FG002 | DPP Minimal: 15-Minute Calls | In Periods 2, 3, and 4, DPP Minimal: 15-Minute Calls were implemented (post-randomization). These were coach-introduced and facilitated but consisted primarily of unstructured peer discussion. Sessions occurred once-per-month (7-12 months) then every two months (13-16 months and 17-24 months) parallel to the DPP-30-minute arm. These intervention sessions were designed to promote peer support and accountability and no new learning materials were provided. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DPP Core Program (0-6 Months) |
|
| |||||||||||||||||||||
| Follow-Up Contacts (7-12 Months) |
| ||||||||||||||||||||||
| Follow-up Contacts (13-18 Months) |
| ||||||||||||||||||||||
| Follow-Up Contacts (19-24 Months) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: DPP Plus: 30-minute Calls | Behavioral: DPP Intensive 30-minute calls include ongoing DPP intervention. Structured, workbook-based 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Bodyweight | Percent bodyweight change (clinic measured) of participant | 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. | Posted | Mean | 95% Confidence Interval | percentage of bodyweight change | 12-month change from baseline bodyweight |
|
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.
We grouped adverse events by body or organ system, including "general disorders". Pregnancy, Puerperium and Perinatal Conditions were deemed N/A because of age. SAE and AE were collected and presented as follows: (1) The DPP Core Intervention (0-6 months) for ALL (N = 314) participants, and (2) The cumulative DPP Post-Core Intervention (7-24 months), categorized by two treatment arms DPP Plus: 30 Minute Calls (n =129) and DPP Minimal: 15 Minute Calls (n = 129).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DPP Core Program | In Period 1, from 0-6 months, the DPP Core Program was implemented for ALL participants (pre-randomization). The DPP Core Program consisted of the base 16-session DPP intervention delivered through group teleconference contact, self-directed videos, and workbooks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Cancer/Multiple Myeloma | Blood and lymphatic system disorders | Non-systematic Assessment | Plasma Cell Cancer, Multiple Myeloma |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M. Venditti PhD, Associate Professor of Psychiatry and Epidemiology | University of Pittsburgh School of Medicine | 4123025228 | vendittiem@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2024 | Apr 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2024 | May 30, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2021 | Jan 11, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| DPP Support: 15-minute calls | Behavioral | No further behavioral intervention materials provided; phone-contacts for mutual social support and accountability |
|
|
Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.
| 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 12-month change from baseline SBP |
| Change in Systolic Blood Pressure (SBP) | SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC) | 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) | 12-month change from baseline DBP |
| Change in Diastolic Blood Pressure (DBP) | DBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC) | 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. | 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. | 24-month change from baseline total score |
| 12-month change from baseline SF-12 score: PCS component and MCS component |
| Change in Health Related Quality of Life | Short-form 12-item health status questionnaire produces two scores; a physical component summary score (PCS) and a mental component summary score (MCS). Scores range from 0-100 with higher scores indicating better health related quality of life. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10. Scores below 50 suggest below average perceived health-related quality of life (e.g., a T-Score of 42 is indicative of a clinically relevant threshold for elevated depressive symptoms on the MCS scale). | 24-month change from baseline SF-12 score: PCS and MCS |
| Change in Mood | The Center for Epidemiologic Studies Depression (CES-D) is a 20- item scale (scores range 0-60 with higher score indicating greater depressive symptoms). Scores should not be considered diagnostic, but they have been used to estimate the severity of depressive symptoms. Scores from 10-15 have been used to indicate mild depressive symptoms, 16-24 "moderate" or "significant" depressive symptoms, and >=25 "severe" depressive symptoms. | 12-month change from baseline CES-D |
| Change in Mood | The Center for Epidemiologic Studies Depression (CES-D) is a 20- item scale (scores range 0-60 with higher score indicating greater depressive symptoms). Scores should not be considered diagnostic, but they have been used to estimate the severity of depressive symptoms. Scores from 10-15 have been used to indicate mild depressive symptoms, 16-24 "moderate" or "significant" depressive symptoms, and >=25 "severe" depressive symptoms. | 24-month change from baseline CES-D |
| No Exercise Clearance |
|
| Spouses (Per Protocol) Excluded |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
|
| NOT COMPLETED |
|
|
| Placebo Comparator: DPP Minimal: 15-minute Calls |
Behavioral: DPP Support 15-minute calls include no further behavioral intervention or self-monitoring materials; phone contacts are unstructured and intended to enhance peer support and accountability. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index | Body mass index (BMI) is a measure of bodyfat based on height and weight. BMI is calculated as average weight divided by average height squared (kg/m2). In the clinic, height is measured in street clothes, without shoes, using a Shorr wall-mounted stadiometer. Weight is taken twice and measured to the nearest 0.1 kg using a SECA 880 digital scale. | Mean | Standard Deviation | kg/m2 |
|
| OG001 | Placebo Comparator: DPP Minimal 15-minute Calls | DPP Support 15-minute calls include no further behavioral intervention or self-monitoring material; phone contacts are unstructured and designed to promote peer support and accountability. |
|
|
|
| Primary | Change in Bodyweight | Percent bodyweight change (clinic measured) of participant | 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. | Posted | Mean | 95% Confidence Interval | percent bodyweight change | 18-month change from baseline bodyweight |
|
|
|
|
| Primary | Change in Bodyweight | Percent bodyweight change (clinic measured) of participant. | 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. | Posted | Mean | 95% Confidence Interval | percent bodyweight change | 24-month change from baseline bodyweight |
|
|
|
|
| Secondary | Change in Waist Circumference | Waist circumference measured in centimeters with a Gulick spring-loaded tape measure. | The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight. | Posted | Mean | 95% Confidence Interval | centimeters | 12-month.change from baseline waist circumference |
|
|
|
|
| Secondary | Change in Waist Circumference | Waist circumference measured in centimeters with a Gulick spring-loaded tape measure. | The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight. | Posted | Mean | 95% Confidence Interval | centimeters | 24-month change from baseline waist circumference |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 12-month change from baseline fasting glucose |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 24-month change from baseline fasting glucose |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | pmol/L | 12-month change from baseline fasting insulin |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was performed. | Posted | Mean | 95% Confidence Interval | pmol/L | 24-month change from baseline fasting insulin |
|
|
|
|
| Secondary | 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 | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | percentage of HbA1c in blood | 12-month change from baseline fasting HbA1c |
|
|
|
|
| Secondary | 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 | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | percentage of HbA1c in blood | 24-month change from baseline fasting HbA1c |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 12-month change from baseline fasting total cholesterol |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 24-month change from baseline fasting total cholesterol |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 12-month change from baseline fasting HDL |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 24-month change from baseline fasting HDL |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 12-month change from baseline fasting LDL |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | mg/dL | 24-month change from baseline fasting LDL |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 12-month change from baseline fasting triglycerides |
|
|
|
|
| Secondary | 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. | The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used. | Posted | Mean | 95% Confidence Interval | mg/dL | 24-month change from baseline fasting triglycerides at 24 months |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure (SBP) | SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC) | The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight. | Posted | Mean | 95% Confidence Interval | mmHg | 12-month change from baseline SBP |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure (SBP) | SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC) | The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight. | Posted | Mean | 95% Confidence Interval | mmHg | 24-month change from baseline SBP |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure (DBP) | DBP blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC) | The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight. | Posted | Mean | 95% Confidence Interval | mmHg | 12-month change from baseline DBP |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure (DBP) | DBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC) | The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight. | Posted | Mean | 95% Confidence Interval | mmHg | 24-month change from baseline DBP. |
|
|
|
|
| Secondary | 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. | The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight with the exception of 1 participant in the Active Comparator and 2 participants in the Placebo Comparator who did not attempt the test due for physical safety reasons. | Posted | Mean | 95% Confidence Interval | units on a scale (higher is better) | 12-month change from baseline on total score |
|
|
|
|
| Secondary | 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. | The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight with the exception of 1 participant in the Placebo Comparator who did not attempt the test due for physical safety reasons. | Posted | Mean | 95% Confidence Interval | units on a scale | 24-month change from baseline total score |
|
|
|
|
| Other Pre-specified | Change in Health Related Quality of Life | Short-form 12-item health status questionnaire (SF-12) produces two scores; a physical component summary score (PCS) and a mental component summary score (MCS). Scores range from 0-100 with higher scores indicating better health related quality of life outcome. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10. Scores below 50 suggest below average perceived health-related quality of life (e.g., a T-Score of 42 is indicative of a clinically relevant threshold for elevated depressive symptoms on the MCS scale). | Note: We obtained mailed survey data from n = 1 additional subject in each of the Active Comparator and Placebo Comparator Groups who did not otherwise have an in-person clinic visit (for the weight primary outcomes) on which the Participant Flow diagram is based. | Posted | Mean | 95% Confidence Interval | T-scores | 12-month change from baseline SF-12 score: PCS component and MCS component |
|
|
|
|
| Other Pre-specified | Change in Health Related Quality of Life | Short-form 12-item health status questionnaire produces two scores; a physical component summary score (PCS) and a mental component summary score (MCS). Scores range from 0-100 with higher scores indicating better health related quality of life. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10. Scores below 50 suggest below average perceived health-related quality of life (e.g., a T-Score of 42 is indicative of a clinically relevant threshold for elevated depressive symptoms on the MCS scale). | Note: We obtained mailed survey data from n = 8 additional subjects in the Active Comparator Group, and n = 9 additional subjects in the Placebo Comparator Group who did not otherwise have an in-person clinic visit (for the weight primary outcomes) on which the Participant Flow diagram is based. | Posted | Mean | 95% Confidence Interval | T-scores | 24-month change from baseline SF-12 score: PCS and MCS |
|
|
|
|
| Other Pre-specified | Change in Mood | The Center for Epidemiologic Studies Depression (CES-D) is a 20- item scale (scores range 0-60 with higher score indicating greater depressive symptoms). Scores should not be considered diagnostic, but they have been used to estimate the severity of depressive symptoms. Scores from 10-15 have been used to indicate mild depressive symptoms, 16-24 "moderate" or "significant" depressive symptoms, and >=25 "severe" depressive symptoms. | Note: CES-D data was missing for n = 2 subjects in the Active Comparator Group (for whom we measured primary weight outcomes in person) and there was n = 2 additional subjects in the Placebo Comparator Group who had no in person weight measures but did submit CES-D data. | Posted | Mean | 95% Confidence Interval | units on a scale | 12-month change from baseline CES-D |
|
|
|
|
| Other Pre-specified | Change in Mood | The Center for Epidemiologic Studies Depression (CES-D) is a 20- item scale (scores range 0-60 with higher score indicating greater depressive symptoms). Scores should not be considered diagnostic, but they have been used to estimate the severity of depressive symptoms. Scores from 10-15 have been used to indicate mild depressive symptoms, 16-24 "moderate" or "significant" depressive symptoms, and >=25 "severe" depressive symptoms. | Note: CES-D data was available for an additional n = 7 subjects in the Active Comparator Group and n = 11 additional subjects in the Placebo Comparator Group who otherwise had no in-person visit and primary outcome weight measures. | Posted | Mean | 95% Confidence Interval | units on a scale | 24-month change from baseline CES-D |
|
|
|
|
| 0 |
| 314 |
| 2 |
| 314 |
| 23 |
| 314 |
| EG001 | Active Comparator: DPP Plus 30-minute Calls | DPP Behavioral Intensive 30-minute calls include ongoing DPP intervention. Structured, workbook-based 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. | 1 | 129 | 2 | 129 | 8 | 129 |
| EG002 | Placebo Comparator: DPP Minimal 15-minute Calls | DPP Support 15-minute calls include no further behavioral intervention or self-monitoring material; phone contacts are unstructured and designed to promote peer support and accountability. Sessions occur once-per-month from months 7 to 12, and every-two-months from months 13 to 24. | 0 | 129 | 4 | 129 | 6 | 129 |
|
| Subdural hematoma | Surgical and medical procedures | Non-systematic Assessment | Fell at home and hit head. Craniotomy performed. |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | In Situ Ductal Cell Breast Cancer |
|
| Covid-19 Hospitalization | Infections and infestations | Non-systematic Assessment | Extended Stay, Respirator Needed |
|
| Cancerous Neuroendocrine Tumor (Stomach) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Endosopic Surgery to Remove 2 Tumors |
|
| Stroke | Vascular disorders | Non-systematic Assessment | Not otherwise specified |
|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Lung Cancer with Metastases to the Brain |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |