Pilot Study on Weight Loss With Robotic Assistance

NCT03314415 | Withdrawn

• 1 other identifier: 12561
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Weight Loss

Keywords

overweight; obesity; weight loss; robot

Outcome Measures

Primary Outcomes (1)

• Weight change

  Primary outcome is weight change during the with-robot and without-robot periods adjusted for week of weight loss.

  5 weeks

Secondary Outcomes (7)

• Change in self-reported eating behavior

  Baseline, once during with-robot phase, Week 5

• Change in self-reported food cravings

  Baseline, once during with-robot phase, Week 5

• Self-reported quality of life

  Baseline, once during with-robot phase, Week 5

• Participant engagement with the robot

  2 weeks

• Robot adherence

  2 weeks

Study Arms (2)

Early robotic intervention

EXPERIMENTAL

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).

Device: Aldebaraan Nao H25

Late robotic intervention

EXPERIMENTAL

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).

Device: Aldebaraan Nao H25

Interventions

Aldebaraan Nao H25 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.

Early robotic intervention; Late robotic intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

• 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.

  PMID: 23426035 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Susan B Roberts, PhD

  Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Senior Scientist

Model Details: Robotic-assisted weight loss

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: October 19, 2017
• Study Start: October 11, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)