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

NCT03850990 | Completed

• 1 other identifier: IRB-300000000
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Behavior; Obesity; Body Weight; Hunger

Outcome Measures

Primary Outcomes (1)

• BMI

  Change in body mass index over 8 weeks on the protocol.

  8 weeks

Study Arms (2)

Placebo group

EXPERIMENTAL

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

No placebo group

EXPERIMENTAL

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

Interventions

Placebo pill and no placebo pill BEHAVIORAL

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

No placebo group; Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

323 Campbell Hall

Birmingham, Alabama, 35249-1179, United States

Location

Related Publications (1)

• 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.

  PMID: 35944376 DERIVED

MeSH Terms

Conditions

Feeding Behavior; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary M Boggiano, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A single group will be assessed for change in body weight across time.

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: September 25, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)