Passive Sensing Technology for Lapse Measurement
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|ClinicalTrials.gov Identifier: NCT03739151|
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Behavioral: Behavioral Obesity Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants in this study receive gold-standard behavioral obesity treatment on an individual basis.|
|Masking:||None (Open Label)|
|Official Title:||Applying Novel Passive Sensing Technology to Target Adherence to Diet in Behavioral Obesity Treatment for Patients With Cardiovascular Disease Risk|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 26, 2021|
Behavioral Obesity Treatment
All participants will receive gold-standard behavioral obesity treatment
Behavioral: Behavioral Obesity Treatment
Self-monitoring. Participants will be taught to record their weight, the calories of each food item, and physical activity using a method of their choice (e.g., commercial smartphone app, paper diary). The clinician will review dietary intake and provide personalized feedback at the outset of session.
Diet. Per national guidelines for weight loss, a daily goal of 1200-1800 kcal/day will be prescribed depending on baseline weight. A Mediterranean diet will be prescribed to meet the recommended calorie goal and be consistent with dietary recommendations for CVD patients.
Exercise. Participants will be encouraged to achieve 250 minutes/week of moderate intensity activity in accordance with current national recommendations for physical activity among individuals attempting weight loss. Participants will be encouraged to gradually increase activity level to achieve approximately 50 minutes of activity over five days per week.
Other Name: Behavioral Weight Loss
- Sensor-based Dietary Lapse [ Time Frame: 24-week frequency of sensor-based dietary lapse ]Participants will wear a wrist-worn 9-axis accelerometer during waking hours that measures wrist-roll motion, which can objectively assess dietary lapses.
- Self-reported Dietary Lapse [ Time Frame: Participants will be asked to complete 7 days of EMA on a biweekly basis for 24 weeks. Therefore, participants will complete EMA at weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. ]Lapses will be assessed via ecological momentary assessment (EMA), a repeated sampling method using electronic forms on smartphone devices.
- Weight [ Time Frame: Weight will be measured at each study appointment (baseline assessment, weekly for 12 weeks, and twice monthly for the subsequent 12 weeks). ]Participants' body weight will be measured to the nearest 0.1 kg using a calibrated digital scale
- Dietary Composition [ Time Frame: Dietary composition will be assessed at baseline and at weeks 5, 11, 17, and 23 ]Dietary composition will be assessed using 24-hour food recall method. The Nutrition Data System for Research (NDSR), a computer-based software application developed at the University of Minnesota Nutrition Coordinating Center (NCC) will facilitate the collection of recalls in a standardized fashion
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): NCT03739151
|Contact: Stephanie P Goldstein, PhDemail@example.com|
|Contact: Graham Thomas, PhDfirstname.lastname@example.org|
|United States, Rhode Island|
|The Miriam Hospital Weight Control and Diabetes Research Center||Recruiting|
|Providence, Rhode Island, United States, 02909|
|Contact: Stephanie P Goldstein, PhD 401-793-9727 email@example.com|
|Contact: Graham Thomas, PhD 401-793-8154 firstname.lastname@example.org|
|Study Chair:||Graham Thomas, PhD||The Miriam Hospital|
|Principal Investigator:||Stephanie P Goldstein, PhD||The Miriam Hospital|