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mHealth Intervention for Older Adults

Primary Purpose

Type2 Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
self-regulation theory-based mHealth behavior intervention
Sponsored by
Boston College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type2 Diabetes focused on measuring Type 2 Diabetes, Obesity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Joslin Diabetes Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mHealth Intervention for Older Adults

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent weight change
Percent weight changes over 3 months
Steps
Steps changes over 3 months
Calorie intake
Calorie intake changes over 3 months

Full Information

First Posted
October 31, 2017
Last Updated
October 19, 2018
Sponsor
Boston College
Collaborators
Joslin Diabetes Center
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1. Study Identification

Unique Protocol Identification Number
NCT03398590
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston College
Collaborators
Joslin Diabetes Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Obesity
Keywords
Type 2 Diabetes, Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mHealth Intervention for Older Adults
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
self-regulation theory-based mHealth behavior intervention
Intervention Description
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 Measure Information:
Title
Acceptability
Description
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 Outcome Measure Information:
Title
Percent weight change
Description
Percent weight changes over 3 months
Time Frame
From baseline to the end of study (up to 3 months)
Title
Steps
Description
Steps changes over 3 months
Time Frame
From baseline to the end of study (up to 3 months)
Title
Calorie intake
Description
Calorie intake changes over 3 months
Time Frame
Mean steps over 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaguang Zheng, PhD
Organizational Affiliation
Boston College Connell School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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mHealth Intervention for Older Adults

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