Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Aging
  • Obesity
  • Prediabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 60 years and 125 years
Gender
Both males and females

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 ov...

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.

Tracking Information

NCT #
NCT03500640
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