The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults

NCT03720327 | Completed DMC

• 2 other identifiers: R21AG053162; HS#2016-2713R21AG053162
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 5

Brief Summary

This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test a mobile-health based intervention which includes use of a Fitbit activity tracker for 3 months, a smartphone application that tracks daily food intake, and one 45 minute counseling session to create personal goals and provide patient education by a health coach; versus Get FIT+ (the same items) plus personalized text messages focusing on participant's activity and nutrition progress as monitored in the app, from the health coach for 3 months. The investigators will measure the impact on participant's diet, physical activity, clinical outcomes, psychosocial well-being, and engagement.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (3)

• Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months

  The Medical Outcomes Study Specific Adherence Scale measures patient adherence to 8 recommended health behaviors (3 items on specific diet/nutrition, 1 item on smoking cessation, 1 item on alcoholic beverages, 1 item on taking prescribed medications, 1 item on regular exercise, 1 item on weight/fluid, 1 item on symptom management). Participants circle the answer that best corresponds to their behavior in the last 4 weeks ("None of the time; 1-A little of the time; 2-Some of the time; 3-A good bit of the time; 4-Most of the time; 5-All of the time"). Scoring is the average of the items for a total specific adherence score.

  baseline, 3 months, 6 months

• Change from Baseline diet patterns at 3 months and 6 months

  3-Day Food Record (ASA24); data from self-recorded diet as entered in smartphone application (My Fitness Pal©)

  baseline, 3 months, 6 months

• Change from baseline physical activity levels at 3 months and 6 months

  data from Fitbit activity tracker as recorded in smartphone application (My Fitness Pal©)

  baseline, 3 months, 6 months

Secondary Outcomes (22)

• change from baseline in HgA1c

  baseline, 3 months, 6 months

• Change from baseline in Anxiety and Depression symptoms

  baseline, 3 months, 6 months

• Change from baseline in patient activation

  baseline, 3 months, 6 months

• Change from Baseline height in centimeters

  baseline, 3 months, 6 months

• Change from baseline weight in kilograms

  baseline, 3 months, 6 months

Study Arms (2)

Get FIT

ACTIVE COMPARATOR

The Get FIT intervention

Behavioral: Get FIT

Get FIT+

EXPERIMENTAL

The Get FIT+ intervention, which includes push-only personalized text messages from a health coach.

Behavioral: Get FIT+

Interventions

Get FIT+ BEHAVIORAL

The Get FIT+ arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; one 45 minute behavioral counseling session to set personal goals and provide education by a health coach; and personalized text messaging for 3 months by a health coach. The health coach will have access to these participants' daily food and activity data through the smartphone application, and will monitor progress and send push-only text messages to participants in this group based on the participant's goals and progress in the areas of physical activity, nutrition, and weight loss.

Get FIT+

Eligibility Criteria

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

You may qualify if:

• aged 60 or greater
• at intermediate (10-20%) or high risk (\>20%) of developing cardiovascular disease (as measured by Framingham Risk Assessment Tool)
• poor eating behaviors (as measured by Block Fruit/Vegetable/Fiber Screener)
• reduced physical activity (as measured by Block Adult Physical Activity Screener)

You may not qualify if:

• cognitive impairment (as measured by Mini-Cog) that impairs ability to understand consent process, surveys, or use of mobile health devices
• chronic drug use
• end stage renal, liver, or pulmonary disease
• current active cancer (i.e., undergoing active treatment for cancer)
• gastrointestinal disease which requires a special diet (e.g. Crohn's, celiac, etc).

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (5)

University of California, Irvine Federally Qualified Health Clinic

Anaheim, California, 92801, United States

Location

The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS)

Irvine, California, 92697-3959, United States

Location

University of California, Irvine Medical Clinic (Gottschalk)

Irvine, California, 92697, United States

Location

The University of California, Irvine Medical Center

Orange, California, 92697-3298, United States

Location

University of California, Irvine Federally Qualified Health Clinic

Santa Ana, California, 92701, United States

Location

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Related Links

• My Fitness Pal

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Lorraine Evangelista, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to one of two groups for the study duration (3 months): 1. control group (Get FIT); 2. intervention group (Get FIT+).

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 25, 2018
• Study Start: January 10, 2019
• Primary Completion: March 12, 2022
• Study Completion: March 12, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

US (5)