Pilot Study on Weight Loss With Robotic Assistance

Tufts University

Status: Withdrawn

Conditions: Weight Loss; Overweight and Obesity

Treatments: Device: Aldebaraan Nao H25

Study type: Interventional

Funder types: Other

Identifiers

NCT03314415

12561

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Early robotic intervention

Experimental group

Description:

Participants randomized to the early robotic intervention will attend robotic assistance sessions for a two-week period earlier in the study (during the first half of the study, approximately). Each participant will attend ten 15-minute robotic assistance sessions to interact with a robot (Aldebaraan Nao H25).

Treatment:

Device: Aldebaraan Nao H25

Late robotic intervention

Experimental group

Description:

Participants randomized to the late robotic intervention will attend robotic assistance sessions for a two-week period later in the study (during the latter half of the study, approximately). Each participant will attend ten 15-minute robotic assistance sessions to interact with a robot (Aldebaraan Nao H25).

Treatment:

Device: Aldebaraan Nao H25