ClinicalTrials.gov
ClinicalTrials.gov Menu

mHealth Intervention for Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03398590
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
Joslin Diabetes Center
Information provided by (Responsible Party):
Yaguang Zheng, Boston College

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Obesity Behavioral: self-regulation theory-based mHealth behavior intervention Not Applicable

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  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Promoting Lifestyle Changes With Mobile Health Technologies for Overweight or Obese Adults With Type 2 Diabetes - Feasibility and Acceptability Study
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Acceptability [ Time Frame: From baseline to the end of study (up to 3 months) ]
    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.


Secondary Outcome Measures :
  1. Percent weight change [ Time Frame: From baseline to the end of study (up to 3 months) ]
    Percent weight changes over 3 months

  2. Steps [ Time Frame: From baseline to the end of study (up to 3 months) ]
    Steps changes over 3 months

  3. Calorie intake [ Time Frame: Mean steps over 3 months ]
    Calorie intake changes over 3 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398590


Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston College
Joslin Diabetes Center
Investigators
Principal Investigator: Yaguang Zheng, PhD Boston College Connell School of Nursing

Responsible Party: Yaguang Zheng, Assistant Professor, Boston College
ClinicalTrials.gov Identifier: NCT03398590     History of Changes
Other Study ID Numbers: 17.192.01
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yaguang Zheng, Boston College:
Type 2 Diabetes
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases