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

NCT03500640 | Completed Results DMC

• 2 other identifiers: PRO17060604R01DK114115
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; PreDiabetes; Aging

Keywords

Intervention; Prevention; Weight Management; Physical Activity; Physical Function

Outcome Measures

Primary Outcomes (3)

• Change in Bodyweight

  Percent bodyweight change (clinic measured) of participant

  12-month change from baseline bodyweight

• Change in Bodyweight

  Percent bodyweight change (clinic measured) of participant

  18-month change from baseline bodyweight

• Change in Bodyweight

  Percent bodyweight change (clinic measured) of participant.

  24-month change from baseline bodyweight

Secondary Outcomes (22)

• Change in Waist Circumference

  12-month.change from baseline waist circumference

• Change in Waist Circumference

  24-month change from baseline waist circumference

• Change in Fasting Glucose

  12-month change from baseline fasting glucose

• Change in Fasting Glucose

  24-month change from baseline fasting glucose

• Change in Fasting Insulin

  12-month change from baseline fasting insulin

Other Outcomes (4)

• Change in Health Related Quality of Life

  12-month change from baseline SF-12 score: PCS component and MCS component

• Change in Health Related Quality of Life

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

• Change in Mood

  12-month change from baseline CES-D

Study Arms (2)

DPP Plus 30-minute calls

ACTIVE COMPARATOR

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

DPP Minimal 15-minute calls

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Behavior Change/Relapse Prevention/Healthy Aging

DPP Plus 30-minute calls

DPP Support: 15-minute calls BEHAVIORAL

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

Also known as: Social Support

DPP Minimal 15-minute calls

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Univ. Pittsburgh School of Medicine-Dept. Psychiatry

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Obesity; Prediabetic State; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Limitations and Caveats

The study is likely underpowered for the primary outcome of weight change, due to recruitment targets not being met during the Covid-19 pandemic and greater than expected loss to follow-up for objective measurements in clinic (starting March 2020).

Results Point of Contact

• Title: Elizabeth M. Venditti PhD, Associate Professor of Psychiatry and Epidemiology
• Organization: University of Pittsburgh School of Medicine

vendittiem@upmc.edu

4123025228

Study Officials

• Elizabeth M Venditti, PhD

  Univ. Pittsburgh School of Medicine-Dept. Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Epidemiology

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 18, 2018
• Study Start: March 27, 2018
• Primary Completion: January 27, 2023
• Study Completion: May 1, 2023
• Last Updated: March 28, 2025
• Results First Posted: August 15, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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)

Locations

US (1)