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Completed

NCT Number: NCT03500640

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

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.

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Key information

Conditions

Obesity Aging Behavior Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univ. Pittsburgh School of Medicine-Dept. Psychiatry

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPP Intensive: 30-minute calls

Behavioral

Ongoing DPP intervention and behavioral progress review to prevent relapse and improve cardiometabolic and functional health targets as keys to healthy aging.

Other names: Behavior Change/Relapse Prevention/Healthy Aging

DPP Support: 15-minute calls

Behavioral

No further behavioral intervention materials provided; phone-contacts for mutual social support and accountability

Other names: Social Support

Primary outcomes

  1. Change in Bodyweight

    Time frame: 12-month change from baseline bodyweight

    Percent bodyweight change (clinic measured) of participant

  2. Change in Bodyweight

    Time frame: 18-month change from baseline bodyweight

    Percent bodyweight change (clinic measured) of participant

  3. Change in Bodyweight

    Time frame: 24-month change from baseline bodyweight

    Percent bodyweight change (clinic measured) of participant.

Secondary outcomes

  1. Change in Waist Circumference

    Time frame: 12-month.change from baseline waist circumference

    Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.

  2. Change in Waist Circumference

    Time frame: 24-month change from baseline waist circumference

    Waist circumference measured in centimeters with a Gulick spring-loaded tape measure.

  3. Change in Fasting Glucose

    Time frame: 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.

  4. Change in Fasting Glucose

    Time frame: 24-month change from baseline 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.

  5. Change in Fasting Insulin

    Time frame: 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.

  6. Change in Fasting Insulin

    Time frame: 24-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.

  7. Change in Hemoglobin (HbA1c)

    Time frame: 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

  8. Change in Hemoglobin (HbA1c)

    Time frame: 24-month change from baseline fasting HbA1c

    HbA1c (percent) blood samples will be taken by venipuncture after confirmed minimum overnight 8-hour fast. Specimens are analyzed at central research laboratory

  9. Change in Total Cholesterol

    Time frame: 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.

  10. Change in Total Cholesterol

    Time frame: 24-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.

  11. Change in High-density Lipoprotein (HDL)

    Time frame: 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.

  12. Change in High-density Lipoprotein (HDL)

    Time frame: 24-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.

  13. Change in Low-density Lipoprotein (LDL)

    Time frame: 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.

  14. Change in Low-density Lipoprotein (LDL)

    Time frame: 24-month change from baseline fasting 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.

  15. Change in Triglycerides

    Time frame: 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.

  16. Change in Triglycerides

    Time frame: 24-month change from baseline fasting triglycerides at 24 months

    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.

  17. Change in Systolic Blood Pressure (SBP)

    Time frame: 12-month change from baseline SBP

    SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)

  18. Change in Systolic Blood Pressure (SBP)

    Time frame: 24-month change from baseline SBP

    SBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)

  19. Change in Diastolic Blood Pressure (DBP)

    Time frame: 12-month change from baseline DBP

    DBP blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)

  20. Change in Diastolic Blood Pressure (DBP)

    Time frame: 24-month change from baseline DBP.

    DBP (mmHg) measured by arm cuff digital blood pressure monitor (OMRON HEM90HXC)

  21. Change in Physical Function

    Time frame: 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.

  22. Change in Physical Function

    Time frame: 24-month change from baseline 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.

Other outcomes

  1. Change in Health Related Quality of Life

    Time frame: 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).

  2. Change in Health Related Quality of Life

    Time frame: 24-month change from baseline SF-12 score: PCS and MCS

    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).

  3. Change in Mood

    Time frame: 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.

  4. Change in Mood

    Time frame: 24-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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: Sustain-DPP

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2018
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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