Passive Sensing Technology for Lapse Measurement
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|ClinicalTrials.gov Identifier: NCT03739151|
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : March 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Behavioral: Behavioral Obesity Treatment||Not Applicable|
Design and overview. This proposal adds continuous passive sensing and periodic dietary assessment to EMA to measure dietary lapses in adults with overweight/obesity and CVD risk (n=40) throughout a BOT program (12 weeks) and a period of weight loss maintenance (12 weeks). Participants will self-report via EMA on meals and snacks, indicting when dietary lapses occur. The ActiGraph Link, a wrist-worn device that can detect the motion of food being brought to the mouth, will be used to objectively detect eating characteristics. Because the composition of foods consumed during lapses is an important facet of lapse behavior that is not measured well via passive sensing or EMA, participants will complete periodic 24-hour dietary recalls via structured interview (split between days with and without lapses) to measure the composition of all food and beverages consumed. Data from the EMA, ActiGraph, and food recalls will be integrated to assess characteristics (i.e., frequency, rate, duration), estimated caloric content, and composition of dietary lapses compared to non-lapses. The study will advance the science of weight control by combining gold-standard and innovative methods to objectively measure dietary lapses and test their association with weight change in BOT.
Recruitment and Screening. Participants will be recruited on a rolling basis using advertisements in local newspapers, the study Center's website, and advertising resources available through the Miriam Hospital. The study will recruit over 12 months aiming for 4 participants per month. Interested individuals will be contacted via telephone to complete initial screening. The study procedures will be summarized, and an in-person appointment will be scheduled for additional screening and orientation. At the orientation meeting, a thorough overview of the study purpose and procedures will be provided and consent obtained. Consented individuals will be asked to complete all screening questions and measures to determine eligibility. Eligible participants will be contacted after this visit to begin treatment. Ineligible individuals will be notified accordingly and provided with referrals for BOT in the community.
The behavioral obesity treatment is described in further detail below.
Assessment schedule. Measures are described in further detail below. The primary outcome of interest, dietary lapse, will be measured on a biweekly basis throughout the 24-week study. Participants will continuously wear a wrist-watch device to passively detect eating episodes. Composition and quality of dietary intake will be measured every 6 weeks. Participants will have weight measured and wrist-watch data downloaded at each weekly appointment during the weight loss treatment phase. During the maintenance phase of treatment, participants will be asked to attend an additional appointment once per month separate from the monthly treatment visit, to initiate data downloading on the wrist-watch sensor and have weight measured.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 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 24, 2018|
|Actual Primary Completion Date :||September 15, 2020|
|Actual Study Completion Date :||September 15, 2020|
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
|United States, Rhode Island|
|The Miriam Hospital Weight Control and Diabetes Research Center|
|Providence, Rhode Island, United States, 02909|
|Study Chair:||Graham Thomas, PhD||The Miriam Hospital|
|Principal Investigator:||Stephanie P Goldstein, PhD||The Miriam Hospital|