Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes
Stopped early · Not applicable
Conditions studied: Diabetes, Senior Syndrome, Frailty
In brief
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.
Key facts
- Study ID
- NCT04132739
- Run by
- Florida International University
- People needed
- 39
- Starts
- 2019-03-01
- Expected to finish
- 2020-03-30
- Last updated by the study team
- 2021-01-06
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 65 years
- Type 2 diabetes
- Hispanic ethnicity
- >3/5 points in the Mini Cog test
- Score >17 on the Mini Nutritional Assessment
You may not qualify if…
- 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
Where it is running
- Dr. Armando Badia Senior Center — Miami, Florida, United States
- Millennium Senior Center — Miami, Florida, United States
- Westwind Senior Center — Miami, Florida, United States
- Victoria Senior Center — Sweetwater, Florida, United States
Full record on ClinicalTrials.gov
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