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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity, PreDiabetes, Aging

Intervention / Treatment
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* Behavioral: DPP Intensive: 30-minute calls
* Behavioral: DPP Support: 15-minute calls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DPP Plus: 30-minute calls<br>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<br>* Ongoing DPP intervention and behavioral progress review to prevent relapse and improve cardiometabolic and functional health targets as keys to healthy aging.<br>* Other names: Behavior Change/Relapse Prevention/Healthy Aging;|
| Placebo Comparator: DPP Minimal: 15-minute calls<br>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<br>* No further behavioral intervention materials provided; phone-contacts for mutual social support and accountability<br>* Other names: Social Support;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bodyweight | percent weight loss | change from baseline bodyweight at 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference | centimeters | change from baseline waist circumference at 12 months | 
| Change in waist circumference | centimeters | change from baseline waist circumference at 24 months | 
| Change in fasting glucose | mg/dL | change from baseline fasting glucose at 12 months | 
| Change in fasting glucose | mg/dL | change from baseline fasting glucose at 24 months | 
| Change in fasting insulin | pmol/L | change from baseline fasting insulin at 12 months | 
| Change in fasting insulin | pmol/L | change from baseline fasting insulin at 24 months | 
| Change in hemoglobin (HbA1c) | HbA1c percent | change from baseline fasting insulin at 12 months | 
| Change in hemoglobin (HbA1c) | HbA1c percent | change from baseline fasting insulin at 24 months | 
| Change in total cholesterol | mg/dL | change from baseline fasting total cholesterol at 12 months | 
| Change in total cholesterol | mg/dL | change from baseline fasting total cholesterol at 24 months | 
| Change in high-density lipoprotein (HDL) | mg/dL | change from baseline fasting HDL at 12 months | 
| Change in high-density lipoprotein (HDL) | mg/dL | change from baseline fasting HDL at 24 months | 
| Change in low-density lipoprotein (LDL) | mg/dL | change from baseline fasting LDL at 12 months | 
| Change in low-density lipoprotein (LDL) | mg/dL | change from baseline fasting LDL at 24 months | 
| Change in triglycerides | mg/dL | change from baseline fasting triglycerides at 12 months | 
| Change in triglycerides | mg/dL | change from baseline fasting triglycerides at 24 months | 
| Change in systolic blood pressure (SBP) | mmHg | change from baseline SBP at 12 months | 
| Change in systolic blood pressure (SBP) | mmHg | change from baseline SBP at 24 months | 
| Change in diastolic blood pressure (DBP) | mmHg | change from baseline DBP at 12 months | 
| Change in diastolic blood pressure (DBP) | mmHg | change from baseline DBP at 24 months | 
| 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; 3 progressive standing balance tests; 5 chair stands. Higher score indicates better physical function. | change from baseline at 12 months | 
| 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; 3 progressive standing balance tests; 5 chair stands. Higher score indicates better physical function. | change from baseline at 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention, Prevention, Weight Management, Physical Activity, Physical Function