Clinical trial NCT02910648: Healthy Behaviors Learning Task and Sleep
Official title: Sleep Conditioning and Healthy Food Choices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight/Obese Population
Keywords: healthy
BMI
weight loss
sleep
healthy sleeper
overweight
obese
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Reinforcing Value of Food assessed by the Reinforcing Value of Food Questionnaire
timeFrame: Approximately 1 week (after second assessment has been taken)
measure: Delay of Gratification assessed by the Kirby Questionnaire
timeFrame: Approximately 1 week (after second assessment has been taken)
measure: 24 hour dietary recall: Nutrition Data System for Research (NDSR) assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) dietary food recall
timeFrame: Approximately 1 week (after second assessment has been taken)
measure: Go/no-go task assessed by the Go/no-go task
timeFrame: Approximately 1 week (after second assessment has been taken)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Bayview Campus, Behavioral Medicine Research Lab
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael T Smith, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: