Passive Sensing Technology for Lapse Measurement
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

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.
    

Intervention name(s): Behavioral Obesity Treatment
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Behavioral Weight Loss
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)
Primary purpose: Other
Keywords: overweight and obesity; eating behavior; nonadherence, patient; ecological momentary assessment; passive sensing; dietary assessment