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

NCT ID: NCT03850990

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2020-05-30

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.

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.

Conditions

Eating Behavior; Obesity; Body Weight; Hunger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Placebo pill and no placebo pill

Intervention Type: BEHAVIORAL

The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.

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.

Group Type: EXPERIMENTAL

Placebo pill and no placebo pill

Intervention Type: BEHAVIORAL

The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.

Interventions

Placebo pill and no placebo pill

The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Mary Boggiano

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary M Boggiano, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

323 Campbell Hall

Birmingham, Alabama, United States

Countries

United States

References

White TR, Wood AS, Ebeling M, Braswell AC, Lausen MA, Isaac S, Gampher JE, Boggiano MM. Change in craving and frequency of consuming palatable foods for non-homeostatic motives after a gut-cued eating intervention. Eat Behav. 2022 Aug;46:101656. doi: 10.1016/j.eatbeh.2022.101656. Epub 2022 Jul 28.

Reference Type: DERIVED

PMID: 35944376 (View on PubMed)

Other Identifiers

IRB-300000000

Identifier Type: -

Identifier Source: org_study_id