Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss
Condition: Eating Behavior; Obesity; Body Weight; Hunger
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Placebo pill and no placebo pill
Intervention type(s): Behavioral
Intervention description(s): The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.
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