Piloting Diet and Exercise Interventions in Older Hispanics With Diabetes

NCT04132739 | Terminated DMC

• 1 other identifier: IRB-19-0037-AM04
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes; Senior Syndrome; Frailty

Outcome Measures

Primary Outcomes (5)

• Changes in hemoglobin A1C.

  Changes in hemoglobin A1C.

  Baseline, 3, 6, 9 and 12 months

• Changes in diet quality based on the Healthy Eating Index scores

  The scores range from 0 to 100. A score of 100 means that the foods align with the Dietary Guidelines for Americans.

  Baseline, 6 and 12 months

• Changes in gait

  Gait will be assessed during preferred speed and fast walking conditions using a GAITRite® system (SN: Q209, CIR Systems Inc).

  Baseline, 3, 6, 9 and 12 months

• Changes in balance

  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.

  Baseline, 3, 6, 9 and 12 months

• Changes in strength

  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.

  Baseline, 3, 6, 9 and 12 months

Study Arms (4)

Control

NO INTERVENTION

Exercise only

EXPERIMENTAL

Behavioral: Exercise

Diet only

EXPERIMENTAL

Behavioral: Diet

Diet + Exercise

EXPERIMENTAL

Behavioral: Diet and exercise

Interventions

Diet BEHAVIORAL

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.

Diet only

Exercise BEHAVIORAL

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.

Exercise only

Diet and exercise BEHAVIORAL

A combination of the diet and exercise interventions following the same procedures previously described.

Diet + Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (4)

Dr. Armando Badia Senior Center

Miami, Florida, 33144, United States

Location

Millennium Senior Center

Miami, Florida, 33175, United States

Location

Westwind Senior Center

Miami, Florida, 33193, United States

Location

Victoria Senior Center

Sweetwater, Florida, 33174, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Brachymorphism-onychodysplasia-dysphalangism syndrome; Frailty

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 21, 2019
• Study Start: March 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)