ClinicalTrials.gg
CompletedNCT03398590Updated Oct 22, 2018

mHealth Intervention for Older Adults

An interventional study of self-regulation theory-based mHealth behavior intervention in Type2 Diabetes and Obesity, sponsored by Boston College. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-22.

Sponsored by Boston College · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type2 Diabetes
  • Obesity

Keywords

  • Type 2 Diabetes
  • Obesity
03

In context

Obesity

6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 9 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralself-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline to the end of study (up to 3 months)

Secondary outcomes

  1. Percent weight change

    Percent weight changes over 3 months

    Time frame: From baseline to the end of study (up to 3 months)

  2. Steps

    Steps changes over 3 months

    Time frame: From baseline to the end of study (up to 3 months)

  3. Calorie intake

    Calorie intake changes over 3 months

    Time frame: Mean steps over 3 months

07

Study locations

1 site
  • Joslin Diabetes Center
    Boston, Massachusetts 02215, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03398590
Lead sponsor
Boston College
Collaborators
Joslin Diabetes Center
Responsible party
Yaguang Zheng (Assistant Professor, Boston College) — Principal investigator
First posted
Jan 12, 2018
Start date
Apr 12, 2017
Primary completion
May 30, 2018
Completion
May 30, 2018
Last update
Oct 22, 2018

Study contacts

Yaguang Zheng, PhD
principal investigator · Boston College Connell School of Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion