Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT03398590
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From baseline to the end of study (up to 3 months)
Percent weight changes over 3 months
Time frame: From baseline to the end of study (up to 3 months)
Steps changes over 3 months
Time frame: Mean steps over 3 months
Calorie intake changes over 3 months
Boston College
Other
Promoting Lifestyle Changes With Mobile Health Technologies for Overweight or Obese Adults With Type 2 Diabetes - Feasibility and Acceptability Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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