mHealth Intervention for Older Adults

Promoting Lifestyle Changes With Mobile Health Technologies for Overweight or Obese Adults With Type 2 Diabetes - Feasibility and Acceptability Study

This is a pilot study to test the feasibility and acceptability of a self-regulation theory-based mHealth behavior intervention for overweight or obese older adults with T2DM.

Study Overview

• Status: Completed
• Conditions: Obesity; Type2 Diabetes
• Intervention / Treatment: Behavioral: self-regulation theory-based mHealth behavior intervention

Detailed Description

This is a pilot study to test the feasibility and acceptability of a self-regulation theory-based mHealth behavior intervention for overweight or obese older adults with T2DM. The main purpose of the intervention is to increase participants' awareness of their behavior patterns and to self-regulate their daily lifestyle behaviors using the results of self-monitoring of weight and blood glucose. This is a One Group Pretest-Posttest Designed study. Ten participants will be recruited from Joslin Diabetes Center, Boston, MA. They will receive a 2-month, self-regulation theory-based weight loss intervention (five 60-minute, biweekly group sessions) and will be provided with a technology toolkit for self-monitoring including an (1) iPhone Plus, (2) the Lose It! app for self-monitoring of dietary intake, (3) Fitbit for self-monitoring of physical activity, (4) Bluetooth-enabled scale for daily weight, and (5) Bluetooth-enabled blood glucose monitor for testing blood glucose levels. There will be a 1-month follow-up after intervention. Assessments will occur at baseline and the end of follow-up. The individual interviews will be conducted with the participants to learn about their experience of technology use to self-manage their weight and diabetes at the end of study.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >=65 years of age;
• BMI between 27-40kg/m2
• Availability of wireless Internet service at home;
• Stable body weight during the previous year (i.e., ±10 pounds) ;
• Not being enrolled in another weight loss program in the past six months;
• Diagnosed with type 2 diabetes for at least 2 years;
• Prescribed insulin or oral medications for at least 1 year;
• No changes in medications for at least 6 months before enrolling in the study;
• Use the LoseIt! app on their computer or smartphone for the 5-day practice period;
• Able to read, write and speak English.

Exclusion Criteria:

• Planning frequent travel, vacations or relocation in next 3 months;
• Current use of weight loss medication;
• Have a history of bariatric surgery;
• Have participated in diabetes education in the previous 12 months;
• Are unable to walk 2 blocks, or had an amputation of a lower limb, severe arthritis or other medical condition that prevents walking for exercise;
• Have severe complications of diabetes, including renal disease (albumin/creatinine >300 μg /mg), severe peripheral diabetic neuropathy, severe peripheral vascular disease, symptomatic autonomic neuropathy, history of myocardial infarction, congestive heart failure, or other severe cardiac disease or severe hypertension (systolic blood pressure greater than 160/90 mmHg);
• Have a diagnosis of a serious mental illness, e.g. schizophrenia, bipolar disorder, substance abuse, and/or eating disorders;
• Have severe visual, hearing or cognitive impairments (e.g., dementia, intellectual disability);
• Unable or unwilling to use the mHealth technology equipment (toolkit) for data collection;
• Do not speak, read and write English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: mHealth Intervention for Older Adults; Pilot study to test the feasibility and acceptability of a self-regulation theory-based mHealth behavior intervention for overweight or obese older adults with T2DM. This is a one Group Pretest-Posttest Designed study. Ten participants will be recruited from Joslin Diabetes Center, Boston, MA. They will receive a 2-month, self-regulation theory-based weight loss intervention (five 60-minute, biweekly group sessions) and will be provided with a technology toolkit for self-monitoring including an (1) iPhone Plus, (2) the Lose It! app for self-monitoring of dietary intake, (3) Fitbit for self-monitoring of physical activity, (4) Bluetooth-enabled scale for daily weight, and (5) Bluetooth-enabled blood glucose monitor for testing blood glucose levels.

Behavioral: self-regulation theory-based mHealth behavior intervention; Participants will receive a self-regulation theory-based mHealth behavior intervention (5 biweekly group sessions, 60 minutes /session). An experienced Certified Diabetes Educator from the Joslin Diabetes Center and PI (Dr. Zheng) who has been trained using self-regulation for weight loss will co-facilitate group sessions. The intervention combines diet modification and increased physical activity with a weekly weight loss goal as well as focuses on improving participants' three typical self-regulation strategies - self-monitoring, self-evaluation and self-reinforcement. Intervention duration will last 2 months with subsequent 1-month follow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Actual Use of Technology will be defined as binary (use vs. nonuse) for each day based on data-stamp information. Then we will calculate percent days of use over time.	From baseline to the end of study (up to 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent weight change	Percent weight changes over 3 months	From baseline to the end of study (up to 3 months)
Steps	Steps changes over 3 months	From baseline to the end of study (up to 3 months)
Calorie intake	Calorie intake changes over 3 months	Mean steps over 3 months

Collaborators and Investigators

• Sponsor: Boston College
• Collaborators: Joslin Diabetes Center
• Investigators: Principal Investigator: Yaguang Zheng, PhD, Boston College Connell School of Nursing

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2017
• Primary Completion (ACTUAL): May 30, 2018
• Study Completion (ACTUAL): May 30, 2018

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: January 6, 2018
• First Posted (ACTUAL): January 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Type 2 Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 17.192.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No