Clinical trial NCT03398590: mHealth Intervention for Older Adults
Official title: Promoting Lifestyle Changes With Mobile Health Technologies for Overweight or Obese Adults With Type 2 Diabetes - Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Obesity
Keywords: Type 2 Diabetes
Obesity
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: Joslin Diabetes Center
First posted: 2018-01-12
Enrollment: 9
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability
timeFrame: From baseline to the end of study (up to 3 months)
Secondary outcomes:
measure: Percent weight change
timeFrame: From baseline to the end of study (up to 3 months)
measure: Steps
timeFrame: From baseline to the end of study (up to 3 months)
measure: Calorie intake
timeFrame: Mean steps over 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Boston College Connell School of Nursing
name: Yaguang Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: