Reducing Cardiometabolic Risk and Promoting Functional Health in Older Adults With Obesity and Prediabetes (Sustain-DPP)

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; PreDiabetes; Aging
• Intervention / Treatment: Behavioral: DPP Intensive: 30-minute calls; Behavioral: DPP Support: 15-minute calls

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.

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DPP Plus 30-minute calls; Following the 6-month, 16-session, DPP core program, 30-minute group telephone calls will be implemented. Structured behavioral DPP maintenance sessions with a healthy aging focus occur once-per-month from months 7 to 12, and every-two-months from months 13 to 24.	Behavioral: DPP 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.; Other Names: Behavior Change/Relapse Prevention/Healthy Aging
Placebo Comparator: DPP Minimal 15-minute calls; Following the 6-month, 16-session, DPP core program, 15-minute group telephone calls will be implemented. Social-support sessions occur once-per-month from months 7 to 12, and every-two-months from months 13 to 24.	Behavioral: DPP Support: 15-minute calls; No further behavioral intervention materials provided; phone-contacts for mutual social support and accountability; Other Names: Social Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bodyweight	Percent bodyweight change (clinic measured) of participant	12-month change from baseline bodyweight
Change in Bodyweight	Percent bodyweight change (clinic measured) of participant	18-month change from baseline bodyweight
Change in Bodyweight	Percent bodyweight change (clinic measured) of participant.	24-month change from baseline bodyweight

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health Related Quality of Life	Short-form 12-item health status questionnaire (SF-12) produces two scores; a physical component summary score (PCS) and a mental component summary score (MCS). Scores range from 0-100 with higher scores indicating better health related quality of life outcome. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10. Scores below 50 suggest below average perceived health-related quality of life (e.g., a T-Score of 42 is indicative of a clinically relevant threshold for elevated depressive symptoms on the MCS scale).	12-month change from baseline SF-12 score: PCS component and MCS component
Change in Health Related Quality of Life	Short-form 12-item health status questionnaire produces two scores; a physical component summary score (PCS) and a mental component summary score (MCS). Scores range from 0-100 with higher scores indicating better health related quality of life. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10. Scores below 50 suggest below average perceived health-related quality of life (e.g., a T-Score of 42 is indicative of a clinically relevant threshold for elevated depressive symptoms on the MCS scale).	24-month change from baseline SF-12 score: PCS and MCS
Change in Mood	The Center for Epidemiologic Studies Depression (CES-D) is a 20- item scale (scores range 0-60 with higher score indicating greater depressive symptoms). Scores should not be considered diagnostic, but they have been used to estimate the severity of depressive symptoms. Scores from 10-15 have been used to indicate mild depressive symptoms, 16-24 "moderate" or "significant" depressive symptoms, and >=25 "severe" depressive symptoms.	12-month change from baseline CES-D
Change in Mood	The Center for Epidemiologic Studies Depression (CES-D) is a 20- item scale (scores range 0-60 with higher score indicating greater depressive symptoms). Scores should not be considered diagnostic, but they have been used to estimate the severity of depressive symptoms. Scores from 10-15 have been used to indicate mild depressive symptoms, 16-24 "moderate" or "significant" depressive symptoms, and >=25 "severe" depressive symptoms.	24-month change from baseline CES-D

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Elizabeth M Venditti, PhD, Univ. Pittsburgh School of Medicine-Dept. Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Prevention; Physical Function; Intervention; Weight Management
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Hyperglycemia; Obesity; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: PRO17060604; R01DK114115 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will follow the guidance of NIDDK on data preparation and sharing policies and insure there is permission to disclose de-identified individual participant-level data collected prior to releasing it to other researchers. In addition, requesting researchers must meet all NIDDK access requirements. Study investigators will maintain strict compliance with Human Research Protections/IRB requirements and use appropriate safeguards before sharing any IPD with other researchers. Within 3 years following final data collection, the investigators will prepare and share the final, completely de-identified dataset (IPD) with NIDDK to be made available to other researchers. However, the investigators will not share other statistical code or data dictionaries.
• IPD Sharing Time Frame: 3 years from the final data collection of the last participant
• IPD Sharing Access Criteria: Investigators will share data through the NIDDK central repository (website shown below)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No