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Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes

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ClinicalTrials.gov Identifier: NCT04132739
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Florida International University

Brief Summary:
Type 2 diabetes affects 9.3% of the U.S. population and health disparities are evident. Compared to non-Hispanic Whites, twice as many Hispanics have type 2 diabetes. The estimated cost of diabetes was $327 billion in 2017. Older adults with type 2 diabetes often have increased risk of falls. Type 2 diabetes standard of care includes one annual self-management session, which rarely include assessments of mobility impairments and falls, and diabetes education programs are less likely to be offered and more likely to be discontinued in economically disadvantaged communities. Consequently, diabetes-related hospitalizations have doubled in the past 20 years. The objective of this study is to pilot test nutrition and exercise interventions to improve diabetes management (e.g. glycemic control and diet quality) and physical function, reduce falls and related healthcare use by disadvantaged older Hispanics with type 2 diabetes. The interventions will be tested separately and in combination to assess their individual and combined effects. We will recruit 60 older Hispanics with type 2 diabetes from 4 senior centers. The exercise intervention was adapted from the evidence-based Otago Exercise Program for falls prevention in older adults. The nutrition intervention aims to improve glycemic control and diet quality. We will cluster-randomize the participants into the following arms (n=15/arm) based on the congregate meal sites they attend: 1) Control (no intervention); 2) Exercise only; 3) Nutrition only, and 4) Exercise+Nutrition. The project will last 15 months; the duration of the interventions will be 6 months, and assessments will be completed at baseline, 3, 6, 9, and 12 months. The impact of the interventions will be assessed based on hemoglobin A1C levels (glycemic control), diet quality (Healthy Eating Index), blood pressure, physical function (balance, gait, strength, body composition, and fear of falls), and self-reported falls and healthcare use.

Condition or disease Intervention/treatment Phase
Diabetes Senior Syndrome Frailty Behavioral: Diet Behavioral: Exercise Behavioral: Diet and exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Experimental: Exercise only Behavioral: Exercise
The Exercise Intervention will involve 30-minute exercise sessions based on the Otago Exercise Program. The exercises involve lower and upper limb strengthening, balance training and a walking plan. The participants will receive illustrations of the exercises to do. Each participant will exercise for 30 minutes, 2x/week during supervised sessions in the facilities and be encouraged to do the exercises by themselves on days the group sessions are not offered. We will also teach self-monitoring for signs of low-blood glucose to ensure safety. Progression will be done every two weeks during the first 2 months, once at month 3, and once at month 6 by increasing intensity and/or difficulty and the walks by increasing continuous walking time and walking speed without compromising safety.

Experimental: Diet only Behavioral: Diet
The Nutrition Intervention will consider the participants' food preferences and concerns for managing glycemic control and maintaining muscle-mass. Each topic will be presented interactively and the participants will be encouraged to attend 2 times/week (attendance will be logged). The topics will be presented as a combination of evidenced-based materials for older adults with type 2 diabetes. We anticipate 3 sessions/topic during the 6-month intervention and will modify the topics and time to fit the needs of our audience. The lessons and materials will be offered in English and Spanish. The food quality change will be measured using a Food Frequency Questionnaire validated in Hispanic populations. The goals are to increase the participants' self-efficacy (belief and self-confidence) that they have the tools necessary to manage diabetes and reduce mobility impairments.

Experimental: Diet + Exercise Behavioral: Diet and exercise
A combination of the diet and exercise interventions following the same procedures previously described.




Primary Outcome Measures :
  1. Changes in hemoglobin A1C. [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Changes in hemoglobin A1C.

  2. Changes in diet quality based on the Healthy Eating Index scores [ Time Frame: Baseline, 6 and 12 months ]
    The scores range from 0 to 100. A score of 100 means that the foods align with the Dietary Guidelines for Americans.

  3. Changes in gait [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Gait will be assessed during preferred speed and fast walking conditions using a GAITRite® system (SN: Q209, CIR Systems Inc).

  4. Changes in balance [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Balance will be assessed based on postural sway frequency, velocity and area during bipedal and single-leg stance for 30 seconds with eyes open and closed on a force plate.

  5. Changes in strength [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Grip strength will be assessed using a Jamar dynamometer allowing adaptable grip, and lower limbs' functional strength will be assessed based on the number of chair-stands completed in 30 seconds.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 65 years
  • Type 2 diabetes
  • Hispanic ethnicity
  • >3/5 points in the Mini Cog test
  • Score >17 on the Mini Nutritional Assessment

Exclusion Criteria:

  • Not willing or not able to exercise due to medical issues or physical limitations
  • Malnutrition: Score <17 on the Mini Nutritional Assessment
  • On dialysis
  • Liver disease,
  • Cancer
  • HIV/AIDS
  • Other physical/psychological condition preventing participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132739


Contacts
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Contact: Edgar R Vieira, PhD 3053480568 evieira@fiu.edu

Locations
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United States, Florida
Dr. Armando Badia Senior Center Recruiting
Miami, Florida, United States, 33144
Contact: Angela Vazquez    786-344-2305    swss@southwestsocial.org   
Millennium Senior Center Recruiting
Miami, Florida, United States, 33175
Contact: Angela Vazquez    786-344-2305    swss@southwestsocial.org   
Westwind Senior Center Recruiting
Miami, Florida, United States, 33193
Contact: Angela Vazquez    786-344-2305    swss@southwestsocial.org   
Victoria Senior Center Recruiting
Sweetwater, Florida, United States, 33174
Contact: Angela Vazquez       swss@southwestsocial.org   
Contact    (786) 344 - 2305      
Sponsors and Collaborators
Florida International University

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Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT04132739    
Other Study ID Numbers: IRB-19-0037-AM04
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Frailty
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes