Passive Sensing Technology for Lapse Measurement

NCT03739151 | Completed DMC

• 1 other identifier: 1F32HL143954-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

overweight and obesity; eating behavior; nonadherence, patient; ecological momentary assessment; passive sensing; dietary assessment

Outcome Measures

Primary Outcomes (1)

• 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.

  24-week frequency of sensor-based dietary lapse

Secondary Outcomes (3)

• Self-reported Dietary Lapse

  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.

• Weight

  Weight will be measured at each study appointment (baseline assessment, weekly for 12 weeks, and twice monthly for the subsequent 12 weeks).

• Dietary Composition

  Dietary composition will be assessed at baseline and at weeks 5, 11, 17, and 23

Study Arms (1)

Behavioral Obesity Treatment

OTHER

All participants will receive gold-standard behavioral obesity treatment

Behavioral: Behavioral Obesity Treatment

Interventions

Behavioral Obesity Treatment BEHAVIORAL

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.

Also known as: Behavioral Weight Loss

Behavioral Obesity Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The Miriam Hospital Weight Control and Diabetes Research Center

Providence, Rhode Island, 02909, United States

Location

Related Publications (3)

• Goldstein SP, Olson KL, Thomas JG. Association of weight and shape concern with weight change and weight-related behaviors in behavioral weight loss treatment. J Behav Med. 2023 Dec;46(6):1049-1056. doi: 10.1007/s10865-023-00451-5. Epub 2023 Sep 23.

  PMID: 37740874 DERIVED

• 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.

  PMID: 35598718 DERIVED

• 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.

  PMID: 33598309 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Feeding Behavior; Patient Compliance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Graham Thomas, PhD

  The Miriam Hospital

  STUDY CHAIR

• Stephanie P Goldstein, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Model Details: All participants in this study receive gold-standard behavioral obesity treatment on an individual basis.

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: October 24, 2018
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

US (1)