Clinical trial NCT03500640: Reducing Cardiometabolic Risk and Promoting Functional Health in Older Adults With Obesity and Prediabetes
Official title: Reducing Cardiometabolic Risk and Promoting Functional Health in Community-based Elders With Obesity and Pre-diabetes: Evaluating Sustainable DPP Follow-up Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
PreDiabetes
Aging
Keywords: Intervention
Prevention
Weight Management
Physical Activity
Physical Function
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-04-18
Enrollment: 314
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Bodyweight
timeFrame: 12-month change from baseline bodyweight
measure: Change in Bodyweight
timeFrame: 18-month change from baseline bodyweight
measure: Change in Bodyweight
timeFrame: 24-month change from baseline bodyweight
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: 12-month.change from baseline waist circumference
measure: Change in Waist Circumference
timeFrame: 24-month change from baseline waist circumference
measure: Change in Fasting Glucose
timeFrame: 12-month change from baseline fasting glucose
measure: Change in Fasting Glucose
timeFrame: 24-month change from baseline fasting glucose
measure: Change in Fasting Insulin
timeFrame: 12-month change from baseline fasting insulin
measure: Change in Fasting Insulin
timeFrame: 24-month change from baseline fasting insulin
measure: Change in Hemoglobin (HbA1c)
timeFrame: 12-month change from baseline fasting HbA1c
measure: Change in Hemoglobin (HbA1c)
timeFrame: 24-month change from baseline fasting HbA1c
measure: Change in Total Cholesterol
timeFrame: 12-month change from baseline fasting total cholesterol
measure: Change in Total Cholesterol
timeFrame: 24-month change from baseline fasting total cholesterol
measure: Change in High-density Lipoprotein (HDL)
timeFrame: 12-month change from baseline fasting HDL
measure: Change in High-density Lipoprotein (HDL)
timeFrame: 24-month change from baseline fasting HDL
measure: Change in Low-density Lipoprotein (LDL)
timeFrame: 12-month change from baseline fasting LDL
measure: Change in Low-density Lipoprotein (LDL)
timeFrame: 24-month change from baseline fasting LDL
measure: Change in Triglycerides
timeFrame: 12-month change from baseline fasting triglycerides
measure: Change in Triglycerides
timeFrame: 24-month change from baseline fasting triglycerides at 24 months
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: 12-month change from baseline SBP
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: 24-month change from baseline SBP
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: 12-month change from baseline DBP
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: 24-month change from baseline DBP.
measure: Change in Physical Function
timeFrame: 12-month change from baseline on total score
measure: Change in Physical Function
timeFrame: 24-month change from baseline total score
Other outcomes:
measure: Change in Health Related Quality of Life
timeFrame: 12-month change from baseline SF-12 score: PCS component and MCS component
measure: Change in Health Related Quality of Life
timeFrame: 24-month change from baseline SF-12 score: PCS and MCS
measure: Change in Mood
timeFrame: 12-month change from baseline CES-D
measure: Change in Mood
timeFrame: 24-month change from baseline CES-D
Locations:
city: Pittsburgh
country: United States
facility: Univ. Pittsburgh School of Medicine-Dept. Psychiatry
state: Pennsylvania
Study officials:
affiliation: Univ. Pittsburgh School of Medicine-Dept. Psychiatry
name: Elizabeth M Venditti, PhD
role: PRINCIPAL_INVESTIGATOR
References: