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Lifestyle Intervention for Senior Diabetics

NCT02348801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-14

No results posted yet for this study

Summary

Older people with diabetes will be assigned to the 1-year lifestyle program or no lifestyle program while continuing usual treatment for diabetes. The lifestyle program will consist of teaching how to practice healthy diet and regular exercise at our facility and continued into the community and home. It is hoped that the results would provide convincing proof about the usefulness of lifestyle change in older patients with diabetes.

Conditions

Interventions

BEHAVIORAL

Weight loss and Exercise

Group behavior therapy sessions designed to acquire positive weight-control skills and attitudes, and practice weight-maintenance skills. A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement. Exercise sessions of \~90 min duration 15 min warm-up of flexibility exercise, followed by \~30 min of aerobic exercise, and, after a brief rest period, \~30 min of resistance training, and finally \~15 min balance exercise) conducted three times weekly supervised at our exercise facility for first six months, and regular exercises continued at community-fitness centers and at home for the following six months.

BEHAVIORAL

Healthy lifestyle

Diabetes support and education

Sponsors & Collaborators

  • American Diabetes Association

    collaborator OTHER

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • Biomedical Research Institute of New Mexico

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Dennis T Villareal, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02348801 on ClinicalTrials.gov