Healthy Behaviors Learning Task and Sleep



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:20 - 55
Updated:9/19/2018
Start Date:July 2016
End Date:June 25, 2019
Contact:Emily Burton
Email:NAP@jhu.edu
Phone:410-550-6165

Use our guide to learn which trials are right for you!

Sleep Conditioning and Healthy Food Choices

This research is being done to study the impacts of a computerized learning task on health
behaviors. The investigators are interested in studying whether this computerized learning
task can help with weight loss.

Over 1/3 of U.S. adults over the age of 20 are obese and obesity is associated with a host of
deleterious medical comorbidities, including heart disease, type 2 diabetes, and cancer,
costing the U.S. approximately $147 billion annually. Novel approaches to address this public
health crisis are needed. Although obesity is multiply determined, it is ultimately a
disorder of positive energy balance, such that weight loss requires increases in physical
activity and improvements in choosing healthy over unhealthy foods. People who are strongly
motivated to eat are more obese, and derive less benefit from weight loss treatments. There
are two general approaches to addressing this pattern: 1) increase the reinforcing value of
healthy foods and/or 2) increase an individual's self-control, i.e., the ability to inhibit
approach responses to less healthy foods.

Emerging research has begun to develop and test training programs that directly modify
tendencies to approach one type of stimulus while resisting temptation of another type of
stimulus for problems other than obesity. For example, researchers have been able to train
heavy drinkers to decrease their weekly alcohol intake7 and chocolate-lovers to reduce their
chocolate intake. However, these researchers did not also incorporate increasing interest in
alternatives (e.g., drinking water instead of beer). This training mechanism has also yet to
be applied to research on obesity and decreasing intake of unhealthy foods.

Participants will be first trained via a computerized training task to inhibit responses to
high-calorie (unhealthy) foods, and to approach alternative low-calorie, high-nutrient
(healthy) foods, in order to test the tasks efficacy. The investigators will include the
training task and incorporate a nap component consistent with Hu and colleagues to evaluate
the utility of sleep conditioning for maintaining training-related changes in inhibition and
approach tendencies after one week. Tones played during the training task will be played
again during the nap, based on randomization

Inclusion Criteria:

- Age between 20 and 55, inclusive

- Body mass index ≥ 25

- Nonsmoker and non-nicotine user for a minimum of the past 6 months

- Not currently using recreational drugs

- Desire to lose weight

- Difficulty losing weight in the past

- AUDIT: <3 women, <4 men (note: score of 4 is okay if both items 2 and 3=0)

- Pittsburgh Sleep Quality Index questionnaire score <8

- Insomnia Severity Index questionnaire score <10

- Epworth Sleepiness Scale <10

- Below the clinical cutoff for Restless Leg Syndrome

- Full sleep cycle between 8:00pm and 9:00am at least 6 days per week

- Apnea hypopnea index <15, as measured by the Nox-T3

Exclusion Criteria:

- Current diagnosis of diabetes mellitus (type 1 or type 2)

- History of major medical disease impacting study

- Significant unstable medical morbidity within the past 6 months

- Significant unstable psychiatric disorder within the past 6 months

- Current use of antidepressants or opioids.

- Lifetime diagnosis of anorexia nervosa or bulimia nervosa

- Lifetime alcohol or substance abuse disorder or dependence

- Suicidal ideation in past year

- Lifetime serious head injury or stroke judged to impact pain or sleep

- Sleep disorder as assessed via the Structured Interview for sleep disorders (SIS-D).

- Women who are pregnant or lactating.

- Unwilling to follow study procedures

- Other (reason judged by PI)

- Food allergies: Individuals who report any food allergies or any history of
anaphylactic reactions related to study procedures during the phone screen for this
study will be excluded from participation. Participants who report avoidance of
specific foods for other medical reasons (e.g., an interaction between a prescribed
medication and a food group, food triggered migraines), if they are related to study
procedures, will also be excluded from participation.

- Takes participant more than 30 minutes to fall asleep

- Positive toxicology screen
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: Michael T Smith, Ph.D
Phone: 410-550-6165
?
mi
from
Baltimore, MD
Click here to add this to my saved trials