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mHealth Intervention for Older Adults

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ClinicalTrials.gov Identifier: NCT03398590
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Type2 Diabetes Obesity Behavioral: self-regulation theory-based mHealth behavior intervention

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 3-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 3-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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 20, 2017
Estimated Primary Completion Date : March 20, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 3-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 3 months with subsequent 3-month follow.


Outcome Measures

Primary Outcome Measures :
  1. Acceptability [ Time Frame: From baseline to the end of study (up to 6 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. Perceived Usefulness and Perceived Ease of Use will also be measured by Technology Acceptance Subscales. Scores for Perceived Usefulness (4 items) and Perceived Ease of Use (4 items) range from 4 to 28, with each item response ranging from 1=very unlikely to 7=very likely. Lower scores indicate higher perceptions. Internal consistency reliability and construct validity has been well established.


Secondary Outcome Measures :
  1. Cardiometabolic risk factor_BMI [ Time Frame: At baseline and at 6 months ]
    BMI (kg/m2) is calculated using baseline weight (kg) and height (m2).

  2. Cardiometabolic risk factor_HbA1c [ Time Frame: At baseline and at 6 months ]
    HbA1c (%) will be collected after a 12-hour fast and will be measured by high-performance liquid chromatography ion capture method (Tosoh Medics, Inc., San Francisco, CA) (reference range 4.0- 6.0%).

  3. Cardiometabolic risk factor_Blood pressure [ Time Frame: At baseline and at 6 months ]
    Blood pressure (BP) in mmHg. BP assessment will follow the standard AHA guidelines and measured using an Omron BP Monitor with ComFit cuff with the subject in a sitting position after at least a 5-min rest. A 2nd reading is taken 2 min after the 1st. An average of the 2 is recorded. Waist circumference in centimeters will be measured twice with a Gullick II measuring tape.

  4. Psychosocial Measure [ Time Frame: At baseline and at 6 months ]
    Self-Regulation of Eating and Exercise will be assessed by a 10-item Self-regulation Scale,141 a 5-likert scale with scores ranging from 10 to 50, a higher score indicating higher levels of self-regulation skill. Example items: I purposefully address my barriers to eating appropriately; I set physical activity goals. Internal consistency was .82 for the exercise-related scale and .84 for the eating-related scale.

  5. Adherence to the step goal [ Time Frame: From baseline to the end of study (up to 6 months) ]
    The data on steps will be obtained from the daily physical activity recordings from Fitbit. Adherence to step goal will be defined as ≥7500 steps per day. If there were no records from Fitbit, adherence to step goals will be coded as non-adherent for that day.

  6. Adherence to the energy intake goal [ Time Frame: From baseline to the end of study (up to 6 months) ]
    The data on energy intake will be obtained from the daily dietary recordings from LoseIt!. Adherence will be calculated by dividing the total number of calories consumed on a specific day by the daily calorie goal, then multiplied by 100 to express the value as a percentage.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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.
Contacts and Locations

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


Contacts
Contact: Jordan Greenberg, BS 617-309-4682 jordan.greenberg@joslin.harvard.edu
Contact: Yaguang Zheng, PhD 617-552-2346 yaguang.zheng@bc.edu

Locations
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Medha Munshi, MD    617-632-8696    medha.munshi@joslin.harvard.edu   
Sponsors and Collaborators
Boston College
Joslin Diabetes Center
Investigators
Principal Investigator: Yaguang Zheng, PhD Boston College Connell School of Nursing
More Information

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: January 12, 2018
Last Verified: January 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