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

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ClinicalTrials.gov Identifier: NCT03500640
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : October 25, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Elizabeth Venditti, University of Pittsburgh

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

Condition or disease Intervention/treatment Phase
Obesity PreDiabetes Aging Behavioral: DPP Intensive: 30-minute calls Behavioral: DPP Support: 15-minute calls Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An initial 16-session Diabetes Prevention Program (DPP), called Group Lifestyle Balance (GLB) and aligned with current Medicare guidelines, will be administered to all enrolled participants primarily through group telephone contact, videos, and workbooks. Subsequently one-half of those enrolled will be randomly assigned to either (1) 30-minute DPP behavior intervention group telephone contact, or (2) 15-minute support group telephone contact for a total of 18 additional follow up months.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Cardiometabolic Risk and Promoting Functional Health in Community-based Elders With Obesity and Pre-diabetes: Evaluating Sustainable DPP Follow-up Strategies
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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 Name: 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 Name: Social Support




Primary Outcome Measures :
  1. Change in bodyweight [ Time Frame: change from baseline bodyweight at 24 months ]
    percent weight loss


Secondary Outcome Measures :
  1. Change in waist circumference [ Time Frame: change from baseline waist circumference at 12 months ]
    centimeters

  2. Change in waist circumference [ Time Frame: change from baseline waist circumference at 24 months ]
    centimeters

  3. Change in fasting glucose [ Time Frame: change from baseline fasting glucose at 12 months ]
    mg/dL

  4. Change in fasting glucose [ Time Frame: change from baseline fasting glucose at 24 months ]
    mg/dL

  5. Change in fasting insulin [ Time Frame: change from baseline fasting insulin at 12 months ]
    pmol/L

  6. Change in fasting insulin [ Time Frame: change from baseline fasting insulin at 24 months ]
    pmol/L

  7. Change in hemoglobin (HbA1c) [ Time Frame: change from baseline fasting insulin at 12 months ]
    HbA1c percent

  8. Change in hemoglobin (HbA1c) [ Time Frame: change from baseline fasting insulin at 24 months ]
    HbA1c percent

  9. Change in total cholesterol [ Time Frame: change from baseline fasting total cholesterol at 12 months ]
    mg/dL

  10. Change in total cholesterol [ Time Frame: change from baseline fasting total cholesterol at 24 months ]
    mg/dL

  11. Change in high-density lipoprotein (HDL) [ Time Frame: change from baseline fasting HDL at 12 months ]
    mg/dL

  12. Change in high-density lipoprotein (HDL) [ Time Frame: change from baseline fasting HDL at 24 months ]
    mg/dL

  13. Change in low-density lipoprotein (LDL) [ Time Frame: change from baseline fasting LDL at 12 months ]
    mg/dL

  14. Change in low-density lipoprotein (LDL) [ Time Frame: change from baseline fasting LDL at 24 months ]
    mg/dL

  15. Change in triglycerides [ Time Frame: change from baseline fasting triglycerides at 12 months ]
    mg/dL

  16. Change in triglycerides [ Time Frame: change from baseline fasting triglycerides at 24 months ]
    mg/dL

  17. Change in systolic blood pressure (SBP) [ Time Frame: change from baseline SBP at 12 months ]
    mmHg

  18. Change in systolic blood pressure (SBP) [ Time Frame: change from baseline SBP at 24 months ]
    mmHg

  19. Change in diastolic blood pressure (DBP) [ Time Frame: change from baseline DBP at 12 months ]
    mmHg

  20. Change in diastolic blood pressure (DBP) [ Time Frame: change from baseline DBP at 24 months ]
    mmHg

  21. Change in physical function [ Time Frame: change from baseline at 12 months ]

    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; 3 progressive standing balance tests; 5 chair stands. Higher score indicates better physical function.


  22. Change in physical function [ Time Frame: change from baseline at 24 months ]

    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; 3 progressive standing balance tests; 5 chair stands. Higher score indicates better physical function.



Other Outcome Measures:
  1. Change in health related quality of life [ Time Frame: change from baseline at 12 months ]
    Short-form 12-item health status questionnaire produces two scores; a physical component summary score and a mental component summary score. 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.

  2. Change in health related quality of life [ Time Frame: change from baseline at 24 months ]
    Short-form 12-item health status questionnaire produces two scores; a physical component summary score and a mental component summary score. 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.

  3. Change in mood [ Time Frame: change from baseline at 12 months ]
    Center for Epidemiologic Studies Depression scale (score ranges 0-60; higher score indicates greater depressive symptoms)

  4. Change in mood [ Time Frame: change from baseline at 24 months ]
    Center for Epidemiologic Studies Depression scale (score ranges 0-60; higher score indicates greater depressive symptoms)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500640


Contacts
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Contact: Elizabeth H Cwenar, BA (412) 647-1845 cwenare@upmc.edu
Contact: Mary O Racek, MEd, BSN, RN (412) 647-1845 racekm@upmc.edu

Locations
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United States, Pennsylvania
Univ. Pittsburgh School of Medicine-Dept. Psychiatry Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Betsy H Cwenar, BA    412-647-1845    cwenare@upmc.edu   
Contact: Mary O Racek, MEd, BSN, RN    412-647-1845    racekm@upmc.edu   
Principal Investigator: Elizabeth M Venditti, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Elizabeth M Venditti, PhD Univ. Pittsburgh School of Medicine-Dept. Psychiatry

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Responsible Party: Elizabeth Venditti, Associate Professor of Psychiatry and Epidemiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03500640     History of Changes
Other Study ID Numbers: PRO17060604
R01DK114115 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 3 years from the final data collection of the last participant
Access Criteria: Investigators will share data through the NIDDK central repository (website shown below)
URL: http://repository.niddk.nih.gov/home/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Venditti, University of Pittsburgh:
Intervention
Prevention
Weight Management
Physical Activity
Physical Function
Additional relevant MeSH terms:
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Diabetes Mellitus
Endocrine System Diseases
Obesity
Prediabetic State
Glucose Intolerance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia