Aging, Obesity, PreDiabetes
Conditions
Keywords
Intervention, Prevention, Weight Management, Physical Activity, Physical Function
Brief summary
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.
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.
Interventions
BEHAVIORALDPP Intensive: 30-minute calls
Ongoing DPP intervention and behavioral progress review to prevent relapse and improve cardiometabolic and functional health targets as keys to healthy aging.
BEHAVIORALDPP Support: 15-minute calls
No further behavioral intervention materials provided; phone-contacts for mutual social support and accountability
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bodyweight | 12-month change from baseline bodyweight | Percent bodyweight change (clinic measured) of participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | 12-month.change from baseline waist circumference | Waist circumference measured in centimeters with a Gulick spring-loaded tape measure. |
| Change in Fasting Glucose | 12-month change from baseline 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. |
| Change in Fasting Insulin | 12-month change from baseline 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. |
| Change in Hemoglobin (HbA1c) | 12-month change from baseline fasting HbA1c | HbA1c (percent) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory |
| Change in Total Cholesterol | 12-month change from baseline fasting 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. |
| Change in High-density Lipoprotein (HDL) | 12-month change from baseline fasting 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. |
| Change in Diastolic Blood Pressure (DBP) | 12-month change from baseline DBP | DBP blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC) |
| Change in Physical Function | 12-month change from baseline on total score | 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. |
| Change in Low-density Lipoprotein (LDL) | 12-month change from baseline fasting 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. |
| Change in Triglycerides | 12-month change from baseline fasting 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. |
| Change in Systolic Blood Pressure (SBP) | 12-month change from baseline SBP | SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Related Quality of Life | 12-month change from baseline SF-12 score: PCS component and MCS component | 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). |
| Change in Mood | 12-month change from baseline CES-D | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 129 |
| 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. | 129 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| DPP Core Program (0-6 Months) | Lost to Follow-up | 26 | 0 | 0 |
| DPP Core Program (0-6 Months) | No Exercise Clearance | 3 | 0 | 0 |
| DPP Core Program (0-6 Months) | Spouses (Per Protocol) Excluded | 6 | 0 | 0 |
| DPP Core Program (0-6 Months) | Withdrawal by Subject | 21 | 0 | 0 |
| Follow-up Contacts (13-18 Months) | Lost to Follow-up | 0 | 1 | 9 |
| Follow-up Contacts (13-18 Months) | Withdrawal by Subject | 0 | 1 | 1 |
| Follow-Up Contacts (19-24 Months) | Death | 0 | 1 | 0 |
| Follow-Up Contacts (19-24 Months) | Withdrawal by Subject | 0 | 2 | 1 |
| Follow-Up Contacts (7-12 Months) | Lost to Follow-up | 0 | 33 | 41 |
| Follow-Up Contacts (7-12 Months) | Withdrawal by Subject | 0 | 1 | 4 |
Baseline characteristics
| Characteristic | Active Comparator: DPP Plus: 30-minute Calls | Placebo Comparator: DPP Minimal: 15-minute Calls | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 67 years | 68 years |
| Body Mass Index | 35.5 kg/m2 STANDARD_DEVIATION 5.6 | 35.4 kg/m2 STANDARD_DEVIATION 6.1 | 35.4 kg/m2 STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized non-Hispanic Black or Black/Mixed Race | 21 Participants | 19 Participants | 40 Participants |
| Race/Ethnicity, Customized non-Hispanic White | 108 Participants | 109 Participants | 217 Participants |
| Sex: Female, Male Female | 87 Participants | 86 Participants | 173 Participants |
| Sex: Female, Male Male | 42 Participants | 43 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 314 | 1 / 129 | 0 / 129 |
| other Total, other adverse events | 23 / 314 | 8 / 129 | 6 / 129 |
| serious Total, serious adverse events | 2 / 314 | 2 / 129 | 4 / 129 |
Outcome results
Primary
Change in Bodyweight
Percent bodyweight change (clinic measured) of participant.
Time frame: 24-month change from baseline bodyweight
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Bodyweight | -4.6 percent bodyweight change |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Bodyweight | -5.1 percent bodyweight change |
p-value: 0.677t-test, 2 sided
Primary
Change in Bodyweight
Percent bodyweight change (clinic measured) of participant
Time frame: 12-month change from baseline bodyweight
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Bodyweight | -7.4 percentage of bodyweight change |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Bodyweight | -6.1 percentage of bodyweight change |
p-value: 0.196t-test, 2 sided
Primary
Change in Bodyweight
Percent bodyweight change (clinic measured) of participant
Time frame: 18-month change from baseline bodyweight
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Bodyweight | -6.4 percent bodyweight change |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Bodyweight | -6.1 percent bodyweight change |
p-value: 0.8t-test, 2 sided
Secondary
Change in Diastolic Blood Pressure (DBP)
DBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Time frame: 24-month change from baseline DBP.
Population: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Diastolic Blood Pressure (DBP) | -1.6 mmHg |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Diastolic Blood Pressure (DBP) | -3.7 mmHg |
p-value: 0.288t-test, 2 sided
Secondary
Change in Diastolic Blood Pressure (DBP)
DBP blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Time frame: 12-month change from baseline DBP
Population: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Diastolic Blood Pressure (DBP) | -4.5 mmHg |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Diastolic Blood Pressure (DBP) | -3.3 mmHg |
p-value: 0.398t-test, 2 sided
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.
Time frame: 24-month change from baseline fasting glucose
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Fasting Glucose | -4.2 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Fasting Glucose | -4.9 mg/dL |
p-value: 0.732t-test, 2 sided
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.
Time frame: 12-month change from baseline fasting glucose
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Fasting Glucose | -5.3 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Fasting Glucose | -2.3 mg/dL |
p-value: 0.14t-test, 2 sided
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.
Time frame: 12-month change from baseline fasting insulin
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Fasting Insulin | -21.3 pmol/L |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Fasting Insulin | -17.6 pmol/L |
p-value: 0.637t-test, 2 sided
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.
Time frame: 24-month change from baseline fasting insulin
Population: The analytic sample here represents only those for whom a valid laboratory test was performed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Fasting Insulin | -16.8 pmol/L |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Fasting Insulin | -8.5 pmol/L |
p-value: 0.521t-test, 2 sided
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
Time frame: 12-month change from baseline fasting HbA1c
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Hemoglobin (HbA1c) | -0.2 percentage of HbA1c in blood |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Hemoglobin (HbA1c) | -0.1 percentage of HbA1c in blood |
p-value: 0.083t-test, 2 sided
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
Time frame: 24-month change from baseline fasting HbA1c
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Hemoglobin (HbA1c) | 0.0 percentage of HbA1c in blood |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Hemoglobin (HbA1c) | 0.1 percentage of HbA1c in blood |
p-value: 0.778t-test, 2 sided
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.
Time frame: 24-month change from baseline fasting HDL
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in High-density Lipoprotein (HDL) | 3.5 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in High-density Lipoprotein (HDL) | 4.7 mg/dL |
p-value: 0.371t-test, 2 sided
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.
Time frame: 12-month change from baseline fasting HDL
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in High-density Lipoprotein (HDL) | 3.3 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in High-density Lipoprotein (HDL) | 2.8 mg/dL |
p-value: 0.712t-test, 2 sided
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.
Time frame: 12-month change from baseline fasting LDL
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Low-density Lipoprotein (LDL) | -6.3 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Low-density Lipoprotein (LDL) | -5.3 mg/dL |
p-value: 0.801t-test, 2 sided
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.
Time frame: 24-month change from baseline fasting LDL
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Low-density Lipoprotein (LDL) | 1.8 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Low-density Lipoprotein (LDL) | -8.6 mg/dL |
p-value: 0.069t-test, 2 sided
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.
Time frame: 24-month change from baseline total score
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Physical Function | -0.12 units on a scale |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Physical Function | -0.05 units on a scale |
p-value: 0.805t-test, 2 sided
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.
Time frame: 12-month change from baseline on total score
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Physical Function | 0.21 units on a scale (higher is better) |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Physical Function | 0.11 units on a scale (higher is better) |
p-value: 0.592t-test, 2 sided
Secondary
Change in Systolic Blood Pressure (SBP)
SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Time frame: 12-month change from baseline SBP
Population: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Systolic Blood Pressure (SBP) | -2.9 mmHg |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Systolic Blood Pressure (SBP) | -1.5 mmHg |
p-value: 0.594t-test, 2 sided
Secondary
Change in Systolic Blood Pressure (SBP)
SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Time frame: 24-month change from baseline SBP
Population: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Systolic Blood Pressure (SBP) | 0.4 mmHg |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Systolic Blood Pressure (SBP) | -3.3 mmHg |
p-value: 0.328t-test, 2 sided
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.
Time frame: 12-month change from baseline fasting total cholesterol
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Total Cholesterol | -6.2 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Total Cholesterol | -6.1 mg/dL |
p-value: 0.982t-test, 2 sided
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.
Time frame: 24-month change from baseline fasting total cholesterol
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Total Cholesterol | 4.1 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Total Cholesterol | -7.2 mg/dL |
p-value: 0.081t-test, 2 sided
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.
Time frame: 12-month change from baseline fasting triglycerides
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Triglycerides | -20.0 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Triglycerides | -10.6 mg/dL |
p-value: 0.193t-test, 2 sided
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.
Time frame: 24-month change from baseline fasting triglycerides at 24 months
Population: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Triglycerides | -5.8 mg/dL |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Triglycerides | -17.0 mg/dL |
p-value: 0.197t-test, 2 sided
Secondary
Change in Waist Circumference
Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.
Time frame: 24-month change from baseline waist circumference
Population: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Waist Circumference | -2.2 centimeters |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Waist Circumference | -2.5 centimeters |
p-value: 0.891t-test, 2 sided
Secondary
Change in Waist Circumference
Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.
Time frame: 12-month.change from baseline waist circumference
Population: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Waist Circumference | -6.0 centimeters |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Waist Circumference | -4.6 centimeters |
p-value: 0.349t-test, 2 sided
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).
Time frame: 12-month change from baseline SF-12 score: PCS component and MCS component
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Health Related Quality of Life | PCS Component Score | 1.0 T-scores |
| Active Comparator: DPP Plus 30-minute Calls | Change in Health Related Quality of Life | MCS Component Score | -0.1 T-scores |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Health Related Quality of Life | PCS Component Score | 1.9 T-scores |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Health Related Quality of Life | MCS Component Score | 0.5 T-scores |
Comparison: The p value provided here is for the physical component summary score (PCS) onlyp-value: 0.421t-test, 2 sided
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).
Time frame: 24-month change from baseline SF-12 score: PCS and MCS
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Health Related Quality of Life | PCS Component | -0.4 T-scores |
| Active Comparator: DPP Plus 30-minute Calls | Change in Health Related Quality of Life | MCS Component | -0.1 T-scores |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Health Related Quality of Life | PCS Component | 1.5 T-scores |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Health Related Quality of Life | MCS Component | -1.5 T-scores |
p-value: 0.16t-test, 2 sided
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.
Time frame: 12-month change from baseline CES-D
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Mood | 0.8 units on a scale |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Mood | -0.5 units on a scale |
p-value: 0.196t-test, 2 sided
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.
Time frame: 24-month change from baseline CES-D
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator: DPP Plus 30-minute Calls | Change in Mood | -0.0 units on a scale |
| Placebo Comparator: DPP Minimal 15-minute Calls | Change in Mood | 0.6 units on a scale |
p-value: 0.532t-test, 2 sided