Clinical trial NCT03739151: Passive Sensing Technology for Lapse Measurement
Official title: Applying Novel Passive Sensing Technology to Target Adherence to Diet in Behavioral Obesity Treatment for Patients With Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: overweight and obesity
eating behavior
nonadherence, patient
ecological momentary assessment
passive sensing
dietary assessment
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-11-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants in this study receive gold-standard behavioral obesity treatment on an individual basis.
Primary purpose: OTHER

Brief summary: Behavioral obesity treatment (BOT) produces clinically significant weight loss and health benefits for many individuals with overweight/obesity and cardiovascular disease (CVD). Yet, about half of patients fall short of expected outcomes and most experience gradual weight regain, thus negating the benefits over time. Lapses (i.e., self-reported eating instances that deviate from the BOT prescribed diet) could explain poor outcomes, but the behavior is understudied because it is difficult to assess in-lab and via self-report. The investigators therefore propose to study lapses using a multimethod approach with the following tools: ecological momentary assessment (EMA; repeated sampling method via mobile device), a wrist-worn device that automatically detects eating behavior and various eating characteristics (frequency, rate, and duration of eating episodes), and 24-hour dietary recalls. The investigators will recruit participants (n=40) with overweight/obesity and one additional CVD risk factor to enroll in a 12-week BOT program and an additional 12-week period of weight loss maintenance. Participants will complete a biweekly 7-day EMA protocol to self-report on eating behavior, including the occurrence of dietary lapse. Participants will continuously wear the wrist-worn ActiGraph Link to characterize eating behavior. Lastly, participants will complete 24-hour dietary recalls via structured interview (split between days with and without lapses) at 6-week intervals to measure the composition of all food and beverages consumed. This study aims to 1) identifying characteristics of lapse behavior by measuring passively-sensed timing, duration, frequency, and rate of eating amongst known lapse episodes, 2) test the association between dietary lapse frequency and weight change, and 3) estimate nutrition composition of dietary lapses. The study approach is consistent with priorities of NHLBI to optimize clinical research and diagnostic strategies to improve CVD and related risk factors.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Overweight or obesity (body mass index 25-45 kg/m2)
* Interested and able to participate in in-person weight loss intervention
* Physician-diagnosed one or more CVD risk factors (type 2 diabetes/prediabetes, hypercholesterolemia, or hypertension).

Exclusion Criteria:

* Report health problems that preclude weight loss or physical activity
* Are currently pregnant or breastfeeding, or planning to be pregnant within the next 6 months,
* Are currently or recently (\< 6 months) enrolled in a commercial weight loss program
* Have lost ≥ 5% of their initial body weight in the last 6 months
* Currently taking weight loss medication
* Have had a previous surgical procedure for weight loss
* Have a history of a clinically diagnosed eating disorder excluding Binge Eating Disorder

Primary outcomes:
measure: Sensor-based Dietary Lapse
timeFrame: 24-week frequency of sensor-based dietary lapse
Secondary outcomes:
measure: Self-reported Dietary Lapse
timeFrame: 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.
measure: Weight
timeFrame: Weight will be measured at each study appointment (baseline assessment, weekly for 12 weeks, and twice monthly for the subsequent 12 weeks).
measure: Dietary Composition
timeFrame: Dietary composition will be assessed at baseline and at weeks 5, 11, 17, and 23
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Graham Thomas, PhD
role: STUDY_CHAIR
affiliation: The Miriam Hospital
name: Stephanie P Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldstein SP, Hoover A, Thomas JG. Combining passive eating monitoring and ecological momentary assessment to characterize dietary lapses from a lifestyle modification intervention. Appetite. 2022 Aug 1;175:106090. doi: 10.1016/j.appet.2022.106090. Epub 2022 May 20.
citation: Goldstein SP, Hoover A, Evans EW, Thomas JG. Combining ecological momentary assessment, wrist-based eating detection, and dietary assessment to characterize dietary lapse: A multi-method study protocol. Digit Health. 2021 Feb 2;7:2055207620988212. doi: 10.1177/2055207620988212. eCollection 2021 Jan-Dec.