Passive Sensing Technology for Lapse Measurement
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/27/2019 |
| Start Date: | October 1, 2018 |
| End Date: | August 26, 2021 |
| Contact: | Stephanie P Goldstein, PhD |
| Email: | stephanie.goldstein@lifespan.org |
| Phone: | 401-793-9727 |
Applying Novel Passive Sensing Technology to Target Adherence to Diet in Behavioral Obesity Treatment for Patients With Cardiovascular Disease Risk
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.
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.
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
We found this trial at
1
site
Providence, Rhode Island 02903
Phone: 401-793-9727
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