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Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss (GCE)

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ClinicalTrials.gov Identifier: NCT03850990
Recruitment Status : Not yet recruiting
First Posted : February 22, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Boggiano, University of Alabama at Birmingham

Brief Summary:
The study will assess the effect of attending to stomach-cues of hunger and fullness on body weight and any additional benefit provided by open-label placebo.

Condition or disease Intervention/treatment Phase
Eating Behavior Obesity Body Weight Hunger Behavioral: Placebo pill and no placebo pill Not Applicable

Detailed Description:

Students and employees from the University of Alabama at Birmingham will consent to four lab visits. On the first visit, they will get measured for a BMI, complete surveys about eating and cognitive styles. They will also get their heart rate and blood pressure taken, and provide a saliva sample for saliva quantification with dental cotton rolls in the mouth before and after a food-craving task (rating computer photos of various foods for liking and desire). They will then see a video explaining the difference between mouth and stomach hunger and instructing them to use a hunger meter to know when to start eating and when to stop eating. They will have a chance to ask questions and will receive a hard copy of the video. They will also receive a satiety tips sheet and will give permission to receive and start receiving daily motivational text messages for the next 2 weeks.

At this time all participants will also watch a short video about placebos and the effect that open-label placebos (non-deceptive placebos; the person knows they are receiving a placebo) have had on previous studies unrelated to obesity or weight loss. If randomized to the placebo group they will take 2 capsules of micro-crystalline cellulose, a non-bioactive ingredient, every day for the duration of the study. Those in the no placebo group will not receive the pills.

The second visit will take place 2 weeks after the first visit. They will be measured for another BMI, complete a meal patterns questionnaire, and have a progress interview about their experience with the new eating instructions. They will receive answers and suggestions corresponding to their interview responses on any challenges faced. Those in the placebo group will have a chance to have any questions or concerns addressed. All participants will then be scheduled for their next visit and will receive the text messages twice a week for the next 3 weeks.

The third visit will take place 3 weeks after the second visit. They will be measured again for a BMI, complete another meal patterns questionnaire, have another progress interview, and get scheduled for their last visit. No text messages will go out between this and the fourth visit.

The fourth visit will take place 3 weeks after the third visit. They will be measured for a BMI and complete another meal patterns questionnaire. They will also get another heart rate, blood pressure, and saliva quantification reading before and after the food-craving task as in the first visit. They will have a final progress interview, followed by a debriefing meeting to let them know more about the study and answer any questions related to any part of the study. They will then be asked if they want to know more about their survey and questionnaire scores. Those in the no placebo group who wish to take placebos will grant permission to be contacted for any future studies that include a placebo group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single group will be assessed for change in body weight across time.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Placebo group
In the first visit, this group will learn about placebo pills from a video and will be placebo pills to take twice a day for 8 weeks. They will be asked to take the pills in conjunction with following the weight-loss protocol.
Behavioral: Placebo pill and no placebo pill
The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.

Experimental: No placebo group
In the first visit, this group will learn about placebo pills from a video but will not be given placebo pills. They will follow the weight-loss protocol without placebo pills.
Behavioral: Placebo pill and no placebo pill
The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.




Primary Outcome Measures :
  1. BMI [ Time Frame: 8 weeks ]
    Change in body mass index over 8 weeks on the protocol.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Desire to lose weight
  • 18-60 years of age
  • Student of employee at the University of Alabama at Birmingham

Exclusion Criteria:

  • Current enrollment in commercial weight loss program
  • Uncontrolled diabetes
  • Uncontrolled hypertension
  • Current bipolar disorder
  • Current or history of eating disorder

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Responsible Party: Mary Boggiano, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03850990     History of Changes
Other Study ID Numbers: IRB-300000000
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes