7-dose Control - Progressive Muscle Relaxation OnlyNCT03468257
Testing a Novel Stress-induced Eating Intervention for Cancer Prevention
A study testing Pavlovian Conditioning in people with 7-dose Control - Progressive Muscle Relaxation Only and 5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days, run by University of California, Los Angeles.
Trial summary
Subjects will be enrolled in a stress-induced eating intervention with 5, 7, or 9 treatments or control. Treatment will comprise imagining a stressful event, engaging in a stress relief activity (Progressive Muscle Relaxation), and consuming a fruit once per day. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 7-dose Control - Progressive Muscle Relaxation Only, 5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days, 7-dose - Pairs Progressive Muscle Relaxation With Fruit 7 Consecutive Days
- What is being tested?
- Pavlovian Conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to May 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or older
- fluent in English
- access to an internet-connected device
- reporting a neutral taste and moderate novelty for at least one fruit
- reporting household size-adjusted income less than or equal to 200% of the federal poverty threshold
- perceived stress scale score of 21.82 (1 SD above the national mean)
- BMI 25
- scoring 3.23 on the Dutch Eating Behavior-Emotional Eating Questionnaire
Who cannot join
- on a diet that would compel them to refrain from eating food in the laboratory buffet
- allergy to any foods presented in the buffet
- selecting a fruit as one or more of top three choices of foods that would make them feel better if stressed
About this study
Subjects will be enrolled in a stress-induced eating intervention with 5, 7, or 9 treatments or control. Treatment will comprise imagining a stressful event, engaging in a stress relief activity (Progressive Muscle Relaxation), and consuming a fruit once per day. There will be one lab visit at baseline in which participants undergo an acute laboratory stressor (i.e., speech and math tasks) and consume food from a buffet. There will be another lab visit at two weeks post-intervention. In the second (and final) lab visit, participants will repeat the acute laboratory stressor (i.e., speech and math tasks) and buffet, and additionally complete questionnaires about their experience in the study.
- Conditions
- 7-dose Control - Progressive Muscle Relaxation Only, 5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days, 7-dose - Pairs Progressive Muscle Relaxation With Fruit 7 Consecutive Days, 9-dose - Pairs Progressive Muscle Relaxation With Fruit 9 Consecutive Days
- Being tested
- Pavlovian Conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pavlovian ConditioningBehavioural
Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation only | Active comparator | Condition 1: 7-dose control - Progressive Muscle Relaxation only Receives: Behavioral: Pavlovian Conditioning |
| Pairs Progressive Muscle Relaxation with fruit | Experimental | Condition 2: 5-dose - Pairs Progressive Muscle Relaxation with fruit 5 consecutive days; Condition 3: 7-dose - Pairs Progressive Muscle Relaxation with fruit 7 consecutive days; Condition 4: 9-dose - Pairs Progressive Muscle Relaxation with fruit 9 consecutive days Receives: Behavioral: Pavlovian Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Eating Index
The Healthy Eating Index was developed by the USDA to capture diet quality. The total score is able to capture both the healthiness of fruits and the unhealthiness of classic comfort foods that are high in calories, fat, and sugar.
Measured: 14 days after last dose
Secondary outcomes (2)
Calorie intake
Calorie intake will be recorded across all the foods that the participants choose to eat in the outcome assessment buffet.
Measured: 14 days after last dose
Acceptability/Credibility
The Credibility/Expectancy Questionnaire is a validated measure to access issues of intervention acceptability, credibility, and expectancy.
Measured: 14 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study startJul 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 7-dose Control - Progressive Muscle Relaxation OnlyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Janet Tomiyama, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468257
- Sponsor's protocol ID
- 16-000893
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2018
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Novel Stress-induced Eating Intervention for Cancer Prevention
- ClinicalTrials.gov ID
- NCT03468257
- Acronym / sponsor ID
- 16-000893
- Conditions
- 7-dose Control - Progressive Muscle Relaxation Only, 5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days, 7-dose - Pairs Progressive Muscle Relaxation With Fruit 7 Consecutive Days, 9-dose - Pairs Progressive Muscle Relaxation With Fruit 9 Consecutive Days
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 16 Mar 2018 (actual)
- 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.
Subjects will be enrolled in a stress-induced eating intervention with 5, 7, or 9 treatments or control. Treatment will comprise imagining a stressful event, engaging in a stress relief activity (Progressive Muscle Relaxation), and consuming a fruit once per day. There will be one lab visit at baseline in which participants undergo an acute laboratory stressor (i.e., speech and math tasks) and consume food from a buffet. There will be another lab visit at two weeks post-intervention. In the second (and final) lab visit, participants will repeat the acute laboratory stressor (i.e., speech and math tasks) and buffet, and additionally complete questionnaires about their experience in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation only | Active comparator | Behavioral: Pavlovian ConditioningCondition 1: 7-dose control - Progressive Muscle Relaxation only |
| Pairs Progressive Muscle Relaxation with fruit | Experimental | Behavioral: Pavlovian ConditioningCondition 2: 5-dose - Pairs Progressive Muscle Relaxation with fruit 5 consecutive days; Condition 3: 7-dose - Pairs Progressive Muscle Relaxation with fruit 7 consecutive days; Condition 4: 9-dose - Pairs Progressive Muscle Relaxation with fruit 9 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 18 or older
- fluent in English
- access to an internet-connected device
- reporting a neutral taste and moderate novelty for at least one fruit
- reporting household size-adjusted income less than or equal to 200% of the federal poverty threshold
Key exclusion criteria (3 listed)
- on a diet that would compel them to refrain from eating food in the laboratory buffet
- allergy to any foods presented in the buffet
- selecting a fruit as one or more of top three choices of foods that would make them feel better if stressed
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 |
|---|---|---|
| Pavlovian ConditioningImagining a stressful event, engaging in progressive muscle relaxation, and eating fruit | Behavioural | Pairs Progressive Muscle Relaxation with fruit, Progressive Muscle Relaxation only |
Primary outcome
Healthy Eating Index
Time frame: 14 days after last dose
The Healthy Eating Index was developed by the USDA to capture diet quality. The total score is able to capture both the healthiness of fruits and the unhealthiness of classic comfort foods that are high in calories, fat, and sugar.
2 secondary outcomes
Calorie intake
Time frame: 14 days after last dose
Acceptability/Credibility
Time frame: 14 days after last dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pavlovian Conditioning in people with 7-dose Control - Progressive Muscle Relaxation Only and 5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days, run by University of California, Los Angeles.
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 8 inclusion and 3 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: withdrawn, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Healthy Eating Index (time frame: 14 days after last dose). 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 Mar 2024.