mHealth Intervention for Older Adults

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398590
• Other study ID #: 17.192.01
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: October 2018
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston College	Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent weight change	Percent weight changes over 3 months	From baseline to the end of study (up to 3 months)
Secondary	Steps	Steps changes over 3 months	From baseline to the end of study (up to 3 months)
Secondary	Calorie intake	Calorie intake changes over 3 months	Mean steps over 3 months