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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03398590|
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment|
|Type2 Diabetes Obesity||Behavioral: self-regulation theory-based mHealth behavior intervention|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Cardiometabolic risk factor_BMI [ Time Frame: At baseline and at 6 months ]BMI (kg/m2) is calculated using baseline weight (kg) and height (m2).
- 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%).
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398590
|Contact: Jordan Greenberg, BSemail@example.com|
|Contact: Yaguang Zheng, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Joslin Diabetes Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Medha Munshi, MD 617-632-8696 email@example.com|
|Principal Investigator:||Yaguang Zheng, PhD||Boston College Connell School of Nursing|