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
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes Obesity||Behavioral: self-regulation theory-based mHealth behavior intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 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 12, 2017|
|Actual Primary Completion Date :||May 30, 2018|
|Actual Study Completion Date :||May 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 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.
- 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.
- Percent weight change [ Time Frame: From baseline to the end of study (up to 3 months) ]Percent weight changes over 3 months
- Steps [ Time Frame: From baseline to the end of study (up to 3 months) ]Steps changes over 3 months
- Calorie intake [ Time Frame: Mean steps over 3 months ]Calorie intake changes over 3 months
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
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Yaguang Zheng, PhD||Boston College Connell School of Nursing|