Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
Study Overview
Brief Summary
The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or reduce frailty. Frailty occurs in older adults and leads people to have falls, become disabled, require nursing home placement, and have increased risk of death. T2D is one of the major risk factors for frailty. T2D is a significant problem in older adults and is known to increase the risk of future frailty.
Detailed Description
Behavioral lifestyle intervention: Participants (N=40) will be randomized to the mHealth+ group Intervention group (Group A; n=20)and mHealth+ individual intervention group (Group B; n=20) group using a randomization table. (1) The mHealth+ group Intervention group (Group A) will receive a modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity. This comprises ten group sessions for lifestyle intervention in 6-months. The group will receive three weekly classes in the first month and then bi-weekly classes for month 2-3, and three monthly session in month four, five, and six. The frequency and layout of these classes will allow participants to master new skills gradually, then eventually wean off, and adopt the modified lifestyle as the part of their daily lives. (2) The mHealth+ individual intervention group (Group B) will receive an abbreviated behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity in one face-to-face individual session at the beginning of the study. In addition, participants will receive self-study materials, from Look Ahead modules, and a monthly follow-up phone calls for the duration of the study (6-months). The goal for these follow up phone calls are to assess understanding of the modules, to promote continued engagement with the study material, and to provide clarification on materials as needed. Participants in the mHealth+ group Intervention group (Group A) and mHealth+ individual intervention group (Group B will receive instruction on how to download an app to help them record their diet and physical activity at the beginning of the study.
Fitbit offers a simple, easy-to-use tool for tracking food and physical activity. It helps set daily calorie budget, and set and work towards goals for nutrient intake, weight loss, exercise, and more. https://www.fitbit.com/inspire 04.12.20: Due to SARS-CoV2 (COVID-19) and social distancing order, the study team are adding hemoglobin Hba1c home test.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Community-dwelling
- •Age 65 and older
- •Men and women of all ethnic groups
- •Self-reported of provider-diagnosed with Type 2 Diabetes (T2D) for at-least 6 months.
- •Received basic diabetes self-management education
- •Stable medication regimen and no medication changes are expected over the next 6 months.
- •Overweight/obese (Body Mass Index (BMI) ≥25 kg/m2
- •Able to read and write in English
- •Own a smartphone
- •At PI discretion, participant is willing/able to comply with the protocol requirements
Exclusion Criteria
- •Unsafe to walk using Exercise Assessment and Screening for You (EASY) criteria or clinical judgement of the PI.
- •History of severe psychiatric disorders or cognitive impairment which interferes with active participation in the study
- •Residence of long-term care facility
- •History of substance abuse in the past year
- •Unwilling to be randomized in a Mobile Health (mHealth+) individual intervention group
Arms & Interventions
Behavioral Lifestyle Intervention
The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Intervention: Lifestyle App (Behavioral)
Behavioral Lifestyle Intervention
The participants will receive behavioral lifestyle intervention with a smartphone-based self-monitoring for diet and physical activity. This group also includes a total of 10 Group sessions over 6 months.
Intervention: Look AHEAD behavior lifestyle intervention (Behavioral)
Group B control arm
Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
Intervention: Lifestyle App (Behavioral)
Group B control arm
Participants use the smart-phone app to record their daily diet and physical activity, with no group sessions.
Intervention: Abbreviated Look AHEAD behavior lifestyle intervention (Behavioral)
Outcomes
Primary Outcomes
Frailty Scale Using Fried's Phenotype Method Based on Five Frailty Characteristics
Time Frame: Baseline to 6 months
1. Self-reported (SR) exhaustion (Y/N ) on Center for Epidemiologic Studies Depression (CES-D) scale: "Do you feel full of energy?" "No" scored a 1 (exhausted). 2. SR unintentional weight loss: "In the last year, have you lost more than 10 pounds unintentionally?". "Yes" scored a 1. 3. SR physical activity over the last year using the Minnesota Leisure Time Activity Questionnaire, (energy expenditure in kcal/week, standardized for sex). The lowest quintile for each sex group received a score of 1 4. Grip strength measured (Kg) with a dynamometer in the dominant hand, standardized using body mass index quartiles and sex. The average of 3 trials was recorded. The lowest quintile for each sex group received a score of 1 (for weak). 5. 10 feet walked at usual pace, standardized based on height and sex. The fastest of 2 trials was recorded. Participants in the lowest quintile for each sex group were considered slow (score =1) A higher scale score from 0-5 indicates greater frailty
Secondary Outcomes
- SPPB Gait Speed(Baseline to 6 months)
- Glycated Hemoglobin (HbA1c)(Baseline to 6 months)
- Short Physical Performance Battery (SPPB) Balance(Baseline to 6 months)
- SPPB Chair Stands(Baseline to 6 months)
Investigators
Rozmin Jiwani
Assistant Professor
The University of Texas Health Science Center at San Antonio