Pilot Study on Weight Loss With Robotic Assistance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2018-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overweight and Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Robotic-assisted weight loss

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early robotic intervention

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).

Group Type EXPERIMENTAL

Aldebaraan Nao H25

Intervention Type DEVICE

The Aldebaraan Nao H25 is a humanoid robot with the capability to interact with people through small movements, gestures, and speech. It does not physically touch the participant at any time.

Late robotic intervention

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).

Group Type EXPERIMENTAL

Aldebaraan Nao H25

Intervention Type DEVICE

The Aldebaraan Nao H25 is a humanoid robot with the capability to interact with people through small movements, gestures, and speech. It does not physically touch the participant at any time.

Interventions

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Aldebaraan Nao H25

The Aldebaraan Nao H25 is a humanoid robot with the capability to interact with people through small movements, gestures, and speech. It does not physically touch the participant at any time.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes