Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes
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|ClinicalTrials.gov Identifier: NCT04132739|
Recruitment Status : Terminated (COVID-19)
First Posted : October 21, 2019
Last Update Posted : January 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Senior Syndrome Frailty||Behavioral: Diet Behavioral: Exercise Behavioral: Diet and exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||March 30, 2020|
|Actual Study Completion Date :||March 30, 2020|
|No Intervention: Control|
|Experimental: Exercise only||
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||
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.
- Changes in hemoglobin A1C. [ Time Frame: Baseline, 3, 6, 9 and 12 months ]Changes in hemoglobin A1C.
- 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.
- 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).
- 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.
- 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.
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
|United States, Florida|
|Dr. Armando Badia Senior Center|
|Miami, Florida, United States, 33144|
|Millennium Senior Center|
|Miami, Florida, United States, 33175|
|Westwind Senior Center|
|Miami, Florida, United States, 33193|
|Victoria Senior Center|
|Sweetwater, Florida, United States, 33174|