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Pilot Study on Weight Loss With Robotic Assistance

Primary Purpose

Overweight and Obesity, Weight Loss

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aldebaraan Nao H25
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring overweight, obesity, weight loss, robot

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Tufts University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early robotic intervention

Late robotic intervention

Arm 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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in self-reported eating behavior
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.
Change in self-reported food cravings
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.
Self-reported quality of life
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.
Participant engagement with the robot
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.
Robot adherence
Robot adherence will be measured based upon attendance to the robotic assistance sessions. Each participant will be scheduled to attend ten robotic assistance sessions.
Dietary intake
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.
Program adherence
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.

Full Information

First Posted
July 17, 2017
Last Updated
November 5, 2018
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT03314415
Brief Title
Pilot Study on Weight Loss With Robotic Assistance
Official Title
Pilot Study on Weight Loss With Robotic Assistance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study will not be implemented and did not enroll participants.
Study Start Date
October 11, 2018 (Anticipated)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Weight Loss
Keywords
overweight, obesity, weight loss, robot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Robotic-assisted weight loss
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early robotic intervention
Arm Type
Experimental
Arm 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).
Arm Title
Late robotic intervention
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Aldebaraan Nao H25
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change
Description
Primary outcome is weight change during the with-robot and without-robot periods adjusted for week of weight loss.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Change in self-reported eating behavior
Description
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.
Time Frame
Baseline, once during with-robot phase, Week 5
Title
Change in self-reported food cravings
Description
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.
Time Frame
Baseline, once during with-robot phase, Week 5
Title
Self-reported quality of life
Description
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.
Time Frame
Baseline, once during with-robot phase, Week 5
Title
Participant engagement with the robot
Description
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.
Time Frame
2 weeks
Title
Robot adherence
Description
Robot adherence will be measured based upon attendance to the robotic assistance sessions. Each participant will be scheduled to attend ten robotic assistance sessions.
Time Frame
2 weeks
Title
Dietary intake
Description
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.
Time Frame
Two 24-hour periods
Title
Program adherence
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan B Roberts, PhD
Organizational Affiliation
Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23426035
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.
Results Reference
background
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.
Results Reference
background

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Pilot Study on Weight Loss With Robotic Assistance

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