COMPLETED

Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to test the effect of a diet and exercise program in older adults with insulin resistance and a motivation disorder known as apathy. The main questions the study aims to answer are: 1. Does the diet and exercise program improve insulin resistance and apathy? 2. Does the addition of soybean to the diet enhance the effect? Participants will be given all meals for 12 weeks and will exercise under supervision. They will undergo a test of insulin sensitivity and complete questionnaires. Researchers will compare the groups given: 1. A diet to moderate the blood glucose response that contains soybean; and 2. A diet to moderate the blood glucose response that does not contain soybean.

Official Title

Lifestyle Intervention for Improving Metabolic and Motivational Outcomes

Quick Facts

Study Start:2023-02-13
Study Completion:2025-10-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05649176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) greater than or equal to 30kg/m2
  2. * Mini-Mental State Examination (MMSE) \> 25
  3. * Geriatric Depression Scale-15 (GDS-15) \< 6
  4. * Apathy Evaluation Scale - score \> 30 or GDS-15 Apathy subscale - score ≥ 2
  5. * Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3
  6. * Sedentary: \< 90 minutes of moderate to vigorous physical activity/week.
  1. * Subjects with a diagnosis of Type 2 diabetes received more than five years ago.
  2. * Participants who have type 1 diabetes
  3. * Participants being treated with prescription or over the counter medications that have a significant effect on insulin resistance, obesity, high density lipoprotein cholesterol, triglycerides, metabolic rate and those that significantly increase body weight.
  4. * Participants who are on concomitant therapy with glucocorticoids.
  5. * Participants with evidence and/or history (within the preceding 6 months) of significant gastrointestinal dysfunction.
  6. * Participants that have had a fluctuation in body weight \>5% in the preceding 2 months.
  7. * Any other conditions that may impede testing of the study hypothesis.

Contacts and Locations

Principal Investigator

Candida J Rebello
PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center

Study Locations (Sites)

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

  • Candida J Rebello, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-13
Study Completion Date2025-10-27

Study Record Updates

Study Start Date2023-02-13
Study Completion Date2025-10-27

Terms related to this study

Additional Relevant MeSH Terms

  • Insulin Sensitivity
  • Apathy