Overweight/Obese PopulationNAPNCT02910648
Healthy Behaviors Learning Task and Sleep
A study testing Modified Go/No-Go Task in people with Overweight/Obese Population, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight/Obese Population
- What is being tested?
- Modified Go/No-Go Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Bayview Campus, Behavioral Medicine Research Lab
Baltimore, Maryland, 21224
About this study
Official title: 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.
Read the 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
- Conditions
- Overweight/Obese Population
- Being tested
- Modified Go/No-Go Task
- Keywords
- healthy, BMI, weight loss, sleep, healthy sleeper, overweight, obese
- Medical subject headings
- Overweight, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Go/No-Go TaskBehavioural
Participants in the experimental group and control sham sound cues group will complete a computerized training task to facilitate learning to respond (press a computer key) to healthy food stimuli and to inhibit responses (not press a computer key) to unhealthy food stimuli. Participants in the control sham go/no-go group will complete a similar task with common office supplies (approach) and tools (inhibit). All participants will also complete a 24 hour dietary recall as described below.
| Study group | Role | What they receive |
|---|---|---|
| Approach/Inhibit group | Experimental | Participants in the experimental group and control sham sound cues group will complete the Modified Go/No-Go Task.
Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring.
White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. Receives: Behavioral: Modified Go/No-Go Task |
| Sham sound cues group | Sham comparator | Participants in the experimental group and control sham sound cues group will complete the Modified Go/No-Go Task.
Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring.
White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. Receives: Behavioral: Modified Go/No-Go Task |
| Sham go/no-go group | Sham comparator | Participants in the control sham go/no-go group will complete a modified Go/No-Go Task with sham approach and inhibit items.
Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring.
White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. Receives: Behavioral: Modified Go/No-Go Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Value of Food assessed by the Reinforcing Value of Food Questionnaire
The reinforcing value of food task (RVF) assesses how hard an individual is willing to hypothetically work to gain access to food compared with an alternative. A series of paired-samples t-tests will be calculated in order to determine whether participants' scores on the reinforcing value of food test changed between baseline and 1 week later. Scores on the RVF have been shown to be associated with BMI. as well as obesity and energy intake.
Measured: Approximately 1 week (after second assessment has been taken)
Delay of Gratification assessed by the Kirby Questionnaire
A series of paired-samples t-tests will be calculated in order to determine whether participants' scores on the Kirby Questionnaire changed between baseline and 1 week later. Each item is scored based on whether the participant chooses the shorter delay and less monetary reward versus the longer delay and a higher monetary reward. Delay-discounting rates are positively correlated with impulsiveness.
Measured: Approximately 1 week (after second assessment has been taken)
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
We will use paired-samples t-tests to determine whether participants mean caloric intake and macronutrient breakdown (e.g., %calories from fat) from the two dietary recalls pre-training task were significantly different from their means post-training task.
Measured: Approximately 1 week (after second assessment has been taken)
Go/no-go task assessed by the Go/no-go task
Performance on go/no-go task as measured by reaction time and accuracy (combined into one score) will be correlated with baseline measures of dietary characteristics and disinhibition
Measured: Approximately 1 week (after second assessment has been taken)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion28 Oct 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/Obese PopulationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael T Smith, Ph.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910648
- Sponsor's protocol ID
- IRB00101818
- Acronym
- NAP
- Status last verified
- Aug 2021
- First submitted
- 20 Sep 2016
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Conditioning and Healthy Food Choices
- ClinicalTrials.gov ID
- NCT02910648
- Acronym / sponsor ID
- NAP / IRB00101818
- Conditions
- Overweight/Obese Population
- Keywords
- healthy, BMI, weight loss, sleep, healthy sleeper, overweight, obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Approach/Inhibit group | Experimental | Behavioral: Modified Go/No-Go TaskParticipants in the experimental group and control sham sound cues group will complete the Modified Go/No-Go Task. Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring. White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. |
| Sham sound cues group | Sham comparator | Behavioral: Modified Go/No-Go TaskParticipants in the experimental group and control sham sound cues group will complete the Modified Go/No-Go Task. Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring. White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. |
| Sham go/no-go group | Sham comparator | Behavioral: Modified Go/No-Go TaskParticipants in the control sham go/no-go group will complete a modified Go/No-Go Task with sham approach and inhibit items. Following completion of post-training assessment measures, participants will be given the opportunity to take a 90-minute while undergoing real-time sleep monitoring. White noise will be played via headphones. Upon entering Stage N3 sleep and/or after having been asleep for 20 minutes and currently in any stage sleep other than N1, sound cues will be played to participants via headphones based on their randomization to 1 of 3 experimental groups. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Go/No-Go TaskParticipants in the experimental group and control sham sound cues group will complete a computerized training task to facilitate learning to respond (press a computer key) to healthy food stimuli and to inhibit responses (not press a computer key) to unhealthy food stimuli. Participants in the control sham go/no-go group will complete a similar task with common office supplies (approach) and tools (inhibit). All participants will also complete a 24 hour dietary recall as described below. | Behavioural | Approach/Inhibit group, Sham go/no-go group, Sham sound cues group |
Primary outcome
Reinforcing Value of Food assessed by the Reinforcing Value of Food Questionnaire
Time frame: Approximately 1 week (after second assessment has been taken)
The reinforcing value of food task (RVF) assesses how hard an individual is willing to hypothetically work to gain access to food compared with an alternative. A series of paired-samples t-tests will be calculated in order to determine whether participants' scores on the reinforcing value of food test changed between baseline and 1 week later. Scores on the RVF have been shown to be associated with BMI. as well as obesity and energy intake.
Delay of Gratification assessed by the Kirby Questionnaire
Time frame: Approximately 1 week (after second assessment has been taken)
A series of paired-samples t-tests will be calculated in order to determine whether participants' scores on the Kirby Questionnaire changed between baseline and 1 week later. Each item is scored based on whether the participant chooses the shorter delay and less monetary reward versus the longer delay and a higher monetary reward. Delay-discounting rates are positively correlated with impulsiveness.
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
Time frame: Approximately 1 week (after second assessment has been taken)
We will use paired-samples t-tests to determine whether participants mean caloric intake and macronutrient breakdown (e.g., %calories from fat) from the two dietary recalls pre-training task were significantly different from their means post-training task.
Go/no-go task assessed by the Go/no-go task
Time frame: Approximately 1 week (after second assessment has been taken)
Performance on go/no-go task as measured by reaction time and accuracy (combined into one score) will be correlated with baseline measures of dietary characteristics and disinhibition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael T Smith, Ph.D principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Go/No-Go Task in people with Overweight/Obese Population, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reinforcing Value of Food assessed by the Reinforcing Value of Food Questionnaire (time frame: Approximately 1 week (after second assessment has been taken)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.