- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314415
Pilot Study on Weight Loss With Robotic Assistance
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
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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.
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Experimental: 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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight change
Time Frame: 5 weeks
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Primary outcome is weight change during the with-robot and without-robot periods adjusted for week of weight loss.
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5 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported eating behavior
Time Frame: Baseline, once during with-robot phase, Week 5
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Participants will complete the Three-Factor Eating Questionnaire, consisting of 18 items, which will be used to assess eating behavior on a 4-point response scale (4=definitely true;3=mostly true;2=mostly false;1=definitely false).
Responses to each of the 18 items are given a score between 1 and 4 and item scores are summed into scale scores for cognitive restraint, uncontrolled eating, and emotional eating.
Total scores will be reported and higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating.
Questionnaires are self-administered.
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Baseline, once during with-robot phase, Week 5
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Change in self-reported food cravings
Time Frame: Baseline, once during with-robot phase, Week 5
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Participants will complete the Food Cravings Questionnaire - Trait, which will be used to assess food cravings on a 6-point response scale (1=Never or NA;2=Rarely; 3=Sometimes;4=Often;5=Usually;6=Always).
Responses to each of the 39 items are given a score between 1 and 6 and item scores are summed into scale scores with higher scores being indicative of greater eating pathology, body mass index (BMI), low dieting success and increases in state food craving during cognitive tasks.
Total scores will be reported.
Questionnaires are self-administered.
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Baseline, once during with-robot phase, Week 5
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Self-reported quality of life
Time Frame: Baseline, once during with-robot phase, Week 5
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Participants will complete the RAND 36-Item Short Form Survey, which will be used to assess eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
All items are scored so that a high score defines a more favorable health state.
In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Scores represent the percentage of total possible score achieved.
Items in the same scale are averaged together to create the 8 scale scores.
Scale scores represent the average for all items in the scale that the respondent answered.
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Baseline, once during with-robot phase, Week 5
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Participant engagement with the robot
Time Frame: 2 weeks
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Visual analog scales, measured by the robot, will be analyzed to evaluate participant engagement during each of the ten 15-minute robotic assistance sessions that will occur over the course of two weeks.
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2 weeks
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Robot adherence
Time Frame: 2 weeks
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Robot adherence will be measured based upon attendance to the robotic assistance sessions.
Each participant will be scheduled to attend ten robotic assistance sessions.
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2 weeks
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Dietary intake
Time Frame: Two 24-hour periods
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Dietary intake will be determined by two 24-hour diet recalls.
One 24-hour recall will occur during the with-robot phase and the other will occur during the without-robot phase.
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Two 24-hour periods
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Program adherence
Time Frame: 5 weeks
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Adherence to the iDiet will be measured by the number videoconference sessions attended by the participant.
Each participant will be scheduled to participate in six videoconference sessions (one/week), each one hour long.
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5 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan B Roberts, PhD, Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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