An interventional study of Aldebaraan Nao H25 in Overweight and Obesity and Weight Loss, sponsored by Tufts University. Withdrawn at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by Tufts University · Not applicable, Interventional, and Treatment
Among 22 studies in Obesity by Tufts University — 5 open to participants now, 6 under way, none of them phase 3. Obesity · Tufts University.
Among the 22 studies in Obesity by Tufts University, this one is the 17th largest by enrollment of the 18 interventional ones that give a count, is the only one that started in 2018, is one of 18 with no phase, and was the 13th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →5 of the 22 studies in Obesity by Tufts University are open now, in 1 country. Recruiting first, the newest first:
Tufts University · Sites in United States
Tufts University · Sites in United States
Tufts University · Sites in United States
Tufts University
Tufts University · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 25 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2018.
Median enrollment 86 across the 18 interventional studies, 427 across the 4 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
2 of the studies in Obesity by Tufts University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07820735Tufts UniversityProject GAME ON! A Digital Comic Tool to Promote Healthy Behaviors | 2027-03 |
| NCT06358859Tufts UniversityDelta GREENS Food is Medicine Intervention | 2027-05 |
Among the 22 studies in Obesity by Tufts University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Weight change
Primary outcome is weight change during the with-robot and without-robot periods adjusted for week of weight loss.
Time frame: 5 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 weeks
Plan to share: No
Start is estimated for Oct 2018; primary completion for Nov 2018, 1 month later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.