Pilot Study on Weight Loss With Robotic Assistance

Study Overview
=================
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.

Official Title
-----------------
Pilot Study on Weight Loss With Robotic Assistance

Conditions
-----------------
Overweight and Obesity, Weight Loss

Intervention / Treatment
-----------------
* Device: Aldebaraan Nao H25


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Robotic-assisted weight loss
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early robotic intervention<br>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<br>* 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.<br>|
| Experimental: Late robotic intervention<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Primary outcome is weight change during the with-robot and without-robot periods adjusted for week of weight loss. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, once during with-robot phase, Week 5 | 
| 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. | Baseline, once during with-robot phase, Week 5 | 
| 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. | Baseline, once during with-robot phase, Week 5 | 
| 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. | 2 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. | 2 weeks | 
| 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. | Two 24-hour periods | 
| 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. | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, obesity, weight loss, robot