Clinical trial NCT03314415: Pilot Study on Weight Loss With Robotic Assistance
Official title: Pilot Study on Weight Loss With Robotic Assistance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overweight and Obesity
Weight Loss
Keywords: overweight
obesity
weight loss
robot
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Robotic-assisted weight loss
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether robotic assistance can help facilitate adherence, engagement, and weight loss in participants enrolled in a behavioral weight loss program. All participants will be enrolled in the same Web-based weight loss program and take part in "robotic assistance sessions" either early or late in the five-week study. These robotic assistance sessions involve speaking one on one with a robot about diet-related progress.

Detailed description: At the start of the five-week study, all participants will be enrolled in a Web-based behavioral weight loss program. The weight loss program places particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. The program will consist of six videoconference sessions delivered by a qualified coach. Menus and other program materials will be available to the participants throughout the study period.

Participants also will be assigned to attend one-on-one "robotic assistance sessions" either early or late in the five-week study. During each robotic assistance session, the participant will speak with the robot about his/her progress with the weight loss program. The robot is programmed to respond to specific issues raised by the participant, but a human operator with thorough knowledge of the weight loss program will be available in case the conversation goes "off script." This human operator can initiate robot behaviors and prompt verbal responses through a text-to-speech interface.

Data from this study will be used to refine the robot for future use and determine whether robotic help can improve a participant's experience in a previously tested weight loss program.

Eligibility criteria: Inclusion Criteria:

* Men and women who are overweight or obese (body mass index of 25-40 kg/m2)
* Want to lose weight and enroll in the study, and are willing to sign the informed consent form
* Able to meet the study requirements for food habits and able to attend online videoconference sessions
* Willing and able to attend in-person robotic assistance sessions, and are not planning to be out of town for more than five days during the study

Exclusion Criteria:

* Self-reported serious food allergies/intolerances, dietary patterns, or active health conditions (e.g., irritable bowel syndrome, Crohn's disease, celiac disease) that would prevent consumption of recommended foods.
* Concurrent participation in another weight loss program or \>2 hours/day of exercise on average.
* Actively dieting or self-reported weight loss of \>10 lb in the past 3 months
* Vulnerable populations, including women who are pregnant and adults who are unable to consent
* Women who are lactating or planning to become pregnant within two months of the start date, per self-report
* Diagnosis of a serious mental health condition
* Non-English speaking individuals
* Medical complications or chronic illness that would prevent full participation (e.g., active cancer)
* Surgical procedures that influence hunger or satiety (e.g., gastric bypass, bowel rerouting, stomach sleeve)
* Primary training as a Clinical Nutritionist or practicing Registered Dietitian
* Diagnosed eating disorder

Primary outcomes:
measure: Weight change
timeFrame: 5 weeks
Secondary outcomes:
measure: Change in self-reported eating behavior
timeFrame: Baseline, once during with-robot phase, Week 5
measure: Change in self-reported food cravings
timeFrame: Baseline, once during with-robot phase, Week 5
measure: Self-reported quality of life
timeFrame: Baseline, once during with-robot phase, Week 5
measure: Participant engagement with the robot
timeFrame: 2 weeks
measure: Robot adherence
timeFrame: 2 weeks
measure: Dietary intake
timeFrame: Two 24-hour periods
measure: Program adherence
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
name: Susan B Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salinardi TC, Batra P, Roberts SB, Urban LE, Robinson LM, Pittas AG, Lichtenstein AH, Deckersbach T, Saltzman E, Das SK. Lifestyle intervention reduces body weight and improves cardiometabolic risk factors in worksites. Am J Clin Nutr. 2013 Apr;97(4):667-76. doi: 10.3945/ajcn.112.046995. Epub 2013 Feb 20.
citation: Briggs P, Scheutz M, Tickle-Degnen L, editors. Are Robots Ready for Administering Health Status Surveys': First Results from an HRI Study with Subjects with Parkinson's Disease. Proceedings of the Tenth Annual ACM/IEEE International Conference on Human-Robot Interaction; 2015: ACM.