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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03398590
Other study ID # 17.192.01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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