Trial Outcomes & Findings for Reducing Cardiometabolic Risk and Promoting Functional Health in Older Adults With Obesity and Prediabetes (NCT NCT03500640)
NCT ID: NCT03500640
Last Updated: 2025-03-28
Results Overview
Percent bodyweight change (clinic measured) of participant
COMPLETED
NA
314 participants
12-month change from baseline bodyweight
2025-03-28
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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.
|
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.
|
|---|---|---|---|
|
DPP Core Program (0-6 Months)
STARTED
|
314
|
0
|
0
|
|
DPP Core Program (0-6 Months)
COMPLETED
|
258
|
0
|
0
|
|
DPP Core Program (0-6 Months)
NOT COMPLETED
|
56
|
0
|
0
|
|
Follow-Up Contacts (7-12 Months)
STARTED
|
0
|
129
|
129
|
|
Follow-Up Contacts (7-12 Months)
COMPLETED
|
0
|
95
|
84
|
|
Follow-Up Contacts (7-12 Months)
NOT COMPLETED
|
0
|
34
|
45
|
|
Follow-up Contacts (13-18 Months)
STARTED
|
0
|
95
|
84
|
|
Follow-up Contacts (13-18 Months)
COMPLETED
|
0
|
93
|
74
|
|
Follow-up Contacts (13-18 Months)
NOT COMPLETED
|
0
|
2
|
10
|
|
Follow-Up Contacts (19-24 Months)
STARTED
|
0
|
68
|
61
|
|
Follow-Up Contacts (19-24 Months)
COMPLETED
|
0
|
65
|
60
|
|
Follow-Up Contacts (19-24 Months)
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
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.
|
|---|---|---|---|
|
DPP Core Program (0-6 Months)
Lost to Follow-up
|
26
|
0
|
0
|
|
DPP Core Program (0-6 Months)
Withdrawal by Subject
|
21
|
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
|
|
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
|
|
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)
Withdrawal by Subject
|
0
|
2
|
1
|
|
Follow-Up Contacts (19-24 Months)
Death
|
0
|
1
|
0
|
Baseline Characteristics
Reducing Cardiometabolic Risk and Promoting Functional Health in Older Adults With Obesity and Prediabetes
Baseline characteristics by cohort
| Measure |
Active Comparator: DPP Plus: 30-minute Calls
n=129 Participants
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.
|
Placebo Comparator: DPP Minimal: 15-minute Calls
n=129 Participants
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.
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
67 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic Black or Black/Mixed Race
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic White
|
108 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Body Mass Index
|
35.5 kg/m2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
35.4 kg/m2
STANDARD_DEVIATION 6.1 • n=7 Participants
|
35.4 kg/m2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12-month change from baseline bodyweightPopulation: 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.
Percent bodyweight change (clinic measured) of participant
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=95 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=84 Participants
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.
|
|---|---|---|
|
Change in Bodyweight
|
-7.4 percentage of bodyweight change
Interval -8.9 to -5.9
|
-6.1 percentage of bodyweight change
Interval -7.4 to -4.7
|
PRIMARY outcome
Timeframe: 18-month change from baseline bodyweightPopulation: 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.
Percent bodyweight change (clinic measured) of participant
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=93 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=74 Participants
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.
|
|---|---|---|
|
Change in Bodyweight
|
-6.4 percent bodyweight change
Interval -8.0 to -4.7
|
-6.1 percent bodyweight change
Interval -7.7 to -4.4
|
PRIMARY outcome
Timeframe: 24-month change from baseline bodyweightPopulation: 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.
Percent bodyweight change (clinic measured) of participant.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=65 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=60 Participants
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.
|
|---|---|---|
|
Change in Bodyweight
|
-4.6 percent bodyweight change
Interval -6.2 to -3.1
|
-5.1 percent bodyweight change
Interval -6.8 to -3.4
|
SECONDARY outcome
Timeframe: 12-month.change from baseline waist circumferencePopulation: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=95 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=84 Participants
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.
|
|---|---|---|
|
Change in Waist Circumference
|
-6.0 centimeters
Interval -7.6 to -4.5
|
-4.6 centimeters
Interval -7.3 to -1.9
|
SECONDARY outcome
Timeframe: 24-month change from baseline waist circumferencePopulation: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=65 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=60 Participants
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.
|
|---|---|---|
|
Change in Waist Circumference
|
-2.2 centimeters
Interval -3.9 to -0.5
|
-2.5 centimeters
Interval -6.1 to 1.2
|
SECONDARY outcome
Timeframe: 12-month change from baseline fasting glucosePopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=66 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=55 Participants
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.
|
|---|---|---|
|
Change in Fasting Glucose
|
-5.3 mg/dL
Interval -7.9 to -2.6
|
-2.3 mg/dL
Interval -5.3 to 0.6
|
SECONDARY outcome
Timeframe: 24-month change from baseline fasting glucosePopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=56 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=43 Participants
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.
|
|---|---|---|
|
Change in Fasting Glucose
|
-4.2 mg/dL
Interval -7.2 to -1.1
|
-4.9 mg/dL
Interval -8.2 to -1.7
|
SECONDARY outcome
Timeframe: 12-month change from baseline fasting insulinPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=71 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=53 Participants
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.
|
|---|---|---|
|
Change in Fasting Insulin
|
-21.3 pmol/L
Interval -31.7 to -10.9
|
-17.6 pmol/L
Interval -29.4 to -5.7
|
SECONDARY outcome
Timeframe: 24-month change from baseline fasting insulinPopulation: The analytic sample here represents only those for whom a valid laboratory test was performed.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=53 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=44 Participants
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.
|
|---|---|---|
|
Change in Fasting Insulin
|
-16.8 pmol/L
Interval -29.4 to -4.1
|
-8.5 pmol/L
Interval -25.3 to 8.3
|
SECONDARY outcome
Timeframe: 12-month change from baseline fasting HbA1cPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
HbA1c (percent) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens were analyzed at a central research laboratory
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=66 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=55 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin (HbA1c)
|
-0.2 percentage of HbA1c in blood
Interval -0.2 to -0.1
|
-0.1 percentage of HbA1c in blood
Interval -0.1 to 0.0
|
SECONDARY outcome
Timeframe: 24-month change from baseline fasting HbA1cPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
HbA1c (percent) blood samples will be taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens are analyzed at central research laboratory
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=56 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=44 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin (HbA1c)
|
0.0 percentage of HbA1c in blood
Interval -0.1 to 0.1
|
0.1 percentage of HbA1c in blood
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: 12-month change from baseline fasting total cholesterolPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=66 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=54 Participants
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.
|
|---|---|---|
|
Change in Total Cholesterol
|
-6.2 mg/dL
Interval -11.6 to -0.8
|
-6.1 mg/dL
Interval -13.9 to 1.7
|
SECONDARY outcome
Timeframe: 24-month change from baseline fasting total cholesterolPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=56 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=43 Participants
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.
|
|---|---|---|
|
Change in Total Cholesterol
|
4.1 mg/dL
Interval -3.1 to 11.4
|
-7.2 mg/dL
Interval -18.6 to 4.2
|
SECONDARY outcome
Timeframe: 12-month change from baseline fasting HDLPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=65 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=54 Participants
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.
|
|---|---|---|
|
Change in High-density Lipoprotein (HDL)
|
3.3 mg/dL
Interval 1.2 to 5.4
|
2.8 mg/dL
Interval 0.7 to 4.8
|
SECONDARY outcome
Timeframe: 24-month change from baseline fasting HDLPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=56 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=43 Participants
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.
|
|---|---|---|
|
Change in High-density Lipoprotein (HDL)
|
3.5 mg/dL
Interval 1.6 to 5.4
|
4.7 mg/dL
Interval 2.7 to 6.8
|
SECONDARY outcome
Timeframe: 12-month change from baseline fasting LDLPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=65 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=53 Participants
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.
|
|---|---|---|
|
Change in Low-density Lipoprotein (LDL)
|
-6.3 mg/dL
Interval -11.2 to -1.4
|
-5.3 mg/dL
Interval -11.9 to 1.4
|
SECONDARY outcome
Timeframe: 24-month change from baseline fasting LDLFasting LDL (mg/dL) blood samples were taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens are analyzed at a central research laboratory.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=56 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=43 Participants
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.
|
|---|---|---|
|
Change in Low-density Lipoprotein (LDL)
|
1.8 mg/dL
Interval -4.4 to 7.9
|
-8.6 mg/dL
Interval -18.8 to 1.6
|
SECONDARY outcome
Timeframe: 12-month change from baseline fasting triglyceridesPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=65 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=53 Participants
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.
|
|---|---|---|
|
Change in Triglycerides
|
-20.0 mg/dL
Interval -28.2 to -11.9
|
-10.6 mg/dL
Interval -23.1 to 1.9
|
SECONDARY outcome
Timeframe: 24-month change from baseline fasting triglycerides at 24 monthsPopulation: The analytic sample here represents only those for whom a valid laboratory test was obtained. No imputation methods were used.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=56 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=43 Participants
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.
|
|---|---|---|
|
Change in Triglycerides
|
-5.8 mg/dL
Interval -16.9 to 5.3
|
-17.0 mg/dL
Interval -30.5 to -3.5
|
SECONDARY outcome
Timeframe: 12-month change from baseline SBPPopulation: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=95 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=84 Participants
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
|
-2.9 mmHg
Interval -6.3 to 0.4
|
-1.5 mmHg
Interval -5.6 to 2.5
|
SECONDARY outcome
Timeframe: 24-month change from baseline SBPPopulation: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=65 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=60 Participants
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
|
0.4 mmHg
Interval -4.0 to 4.9
|
-3.3 mmHg
Interval -9.5 to 2.9
|
SECONDARY outcome
Timeframe: 12-month change from baseline DBPPopulation: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
DBP blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=95 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=84 Participants
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.
|
|---|---|---|
|
Change in Diastolic Blood Pressure (DBP)
|
-4.5 mmHg
Interval -6.3 to -2.7
|
-3.3 mmHg
Interval -5.6 to -0.9
|
SECONDARY outcome
Timeframe: 24-month change from baseline DBP.Population: The analysis population corresponds to the that of the objectively measured primary outcome of bodyweight.
DBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=65 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=60 Participants
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.
|
|---|---|---|
|
Change in Diastolic Blood Pressure (DBP)
|
-1.6 mmHg
Interval -3.7 to 0.5
|
-3.7 mmHg
Interval -7.0 to -0.4
|
SECONDARY outcome
Timeframe: 12-month change from baseline on total scorePopulation: 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.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=94 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=82 Participants
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.
|
|---|---|---|
|
Change in Physical Function
|
0.21 units on a scale (higher is better)
Interval -0.03 to 0.45
|
0.11 units on a scale (higher is better)
Interval -0.19 to 0.41
|
SECONDARY outcome
Timeframe: 24-month change from baseline total scorePopulation: 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.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=65 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=59 Participants
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.
|
|---|---|---|
|
Change in Physical Function
|
-0.12 units on a scale
Interval -0.53 to 0.29
|
-0.05 units on a scale
Interval -0.44 to 0.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-month change from baseline SF-12 score: PCS component and MCS componentPopulation: 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.
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).
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=96 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=85 Participants
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.
|
|---|---|---|
|
Change in Health Related Quality of Life
PCS Component Score
|
1.0 T-scores
Interval -0.7 to 2.6
|
1.9 T-scores
Interval 0.2 to 3.7
|
|
Change in Health Related Quality of Life
MCS Component Score
|
-0.1 T-scores
Interval -1.7 to 1.6
|
0.5 T-scores
Interval -1.3 to 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-month change from baseline SF-12 score: PCS and MCSPopulation: 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.
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).
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=73 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=69 Participants
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.
|
|---|---|---|
|
Change in Health Related Quality of Life
PCS Component
|
-0.4 T-scores
Interval -2.2 to 1.3
|
1.5 T-scores
Interval -0.6 to 3.7
|
|
Change in Health Related Quality of Life
MCS Component
|
-0.1 T-scores
Interval -2.1 to 1.8
|
-1.5 T-scores
Interval -3.9 to 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-month change from baseline CES-DPopulation: 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.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=93 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=87 Participants
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.
|
|---|---|---|
|
Change in Mood
|
0.8 units on a scale
Interval -0.6 to 2.2
|
-0.5 units on a scale
Interval -1.8 to 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-month change from baseline CES-DPopulation: 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.
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.
Outcome measures
| Measure |
Active Comparator: DPP Plus 30-minute Calls
n=72 Participants
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=71 Participants
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.
|
|---|---|---|
|
Change in Mood
|
-0.0 units on a scale
Interval -1.3 to 1.3
|
0.6 units on a scale
Interval -1.0 to 2.3
|
Adverse Events
DPP Core Program
Active Comparator: DPP Plus 30-minute Calls
Placebo Comparator: DPP Minimal 15-minute Calls
Serious adverse events
| Measure |
DPP Core Program
n=314 participants at risk
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
|
Active Comparator: DPP Plus 30-minute Calls
n=129 participants at risk
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.
|
Placebo Comparator: DPP Minimal 15-minute Calls
n=129 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood Cancer/Multiple Myeloma
|
0.00%
0/314 • 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).
|
0.78%
1/129 • 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).
|
0.00%
0/129 • 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).
|
|
Surgical and medical procedures
Subdural hematoma
|
0.32%
1/314 • 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).
|
0.00%
0/129 • 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).
|
0.00%
0/129 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/314 • 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).
|
0.78%
1/129 • 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).
|
0.00%
0/129 • 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).
|
|
Infections and infestations
Covid-19 Hospitalization
|
0.00%
0/314 • 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).
|
0.00%
0/129 • 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).
|
0.78%
1/129 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancerous Neuroendocrine Tumor (Stomach)
|
0.00%
0/314 • 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).
|
0.00%
0/129 • 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).
|
0.78%
1/129 • 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).
|
|
Vascular disorders
Stroke
|
0.00%
0/314 • 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).
|
0.00%
0/129 • 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).
|
1.6%
2/129 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.32%
1/314 • 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).
|
0.00%
0/129 • 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).
|
0.00%
0/129 • 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).
|
Other adverse events
| Measure |
DPP Core Program
n=314 participants at risk
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
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Active Comparator: DPP Plus 30-minute Calls
n=129 participants at risk
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.
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Placebo Comparator: DPP Minimal 15-minute Calls
n=129 participants at risk
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.
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Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
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7.3%
23/314 • Number of events 23 • 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).
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6.2%
8/129 • Number of events 8 • 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).
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4.7%
6/129 • Number of events 6 • 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).
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Additional Information
Elizabeth M. Venditti PhD, Associate Professor of Psychiatry and Epidemiology
University of Pittsburgh School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place