WillpowerSWGNCT02258477

A Pilot Study: Snacking, Willpower and Glucose Availability

A study testing Sequence 1, Sequence 2 and Sequence 3 in people with Willpower, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test whether there is a threshold of glucose that will result in improved ease of resistance to problem foods (tested by comparing three… Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Willpower
What is being tested?: Sequence 1, Sequence 2 and Sequence 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Oct 2014to Feb 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Females ages 18 - 65 years.
Self-identify as regular snackers, with a specific problem food, who have trouble with over-consuming this snack food.
Have intentionally lost weight in the last year and are seeking to maintain that weight loss or have unintentionally gained weight in the last year and are concerned about it.
Generally healthy.

Who cannot join

Pregnant or trying to become pregnant.
Diagnosis of type 1 or type 2 diabetes
Not willing or able to follow study guidelines (ie: consuming the study beverage daily for four weeks, or completing daily compliance logs)
Current smoker (or has stopped smoking within the last 6 months)
Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents, etc).
Current or history of eating disorder (anorexia, bulimia, or diagnosed binge eating disorder)
Current alcohol or drug abuse or dependence
Any medical condition for which daily snacking of such problem foods would be inadvisable (i.e.: a subject with hypertension advised to avoid sodium).

Trial locations and contacts

1 site in 1 country.

United States1 site

Anschutz Health and Wellness Center
Aurora, Colorado, 80045

Other trials in United States

About this study

Read the detailed description

Ingestion of 100 calories of glucose during individually pre-determined times of waning dietary self-control will result in improved ease of resistance to problem foods when compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)

Conditions: Willpower
Being tested: Sequence 1, Sequence 2, Sequence 3, Sequence 4
Medical subject headings: Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sequence 1Dietary supplement
100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
Sequence 2Dietary supplement
Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
Sequence 3Dietary supplement
50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
Sequence 4Dietary supplement
10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.

Study groups in NCT02258477
Study group	Role	What they receive
Sequence 1 (D-B-A-C)	Active comparator	100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4. Receives: Dietary Supplement: Sequence 1
Sequence 2 (A-D-C-B)	Active comparator	Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4. Receives: Dietary Supplement: Sequence 2
Sequence 3 (C-A-B-D)	Active comparator	50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4. Receives: Dietary Supplement: Sequence 3
Sequence 4 (B-C-D-A)	Active comparator	10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4. Receives: Dietary Supplement: Sequence 4

What is being measured

The primary outcome is the main question the study is designed to answer.

Responses to the Control of Eating Questionnaire
Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome.
Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).
Measured: 4 weeks

Secondary outcomes (2)

Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.
Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.
Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.
Measured: 4 weeks
Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.
Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Feb 2015

First posted7 Oct 2014 (estimated)
Study startOct 2014
Primary completionJan 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for WillpowerStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe 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
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02258477
Sponsor's protocol ID: 14-1485
Acronym: SWG
Status last verified: Feb 2016
First submitted: 2 Oct 2014
Last updated: 4 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hand GA, Shook RP, Paluch AE, Baruth M, Crowley EP, Jaggers JR, Prasad VK, Hurley TG, Hebert JR, O'Connor DP, Archer E, Burgess S, Blair SN. The energy balance study: the design and baseline results for a longitudinal study of energy balance. Res Q Exerc Sport. 2013 Sep;84(3):275-86. doi: 10.1080/02701367.2013.816224.
PubMed 24261006
Chang SH, Pollack LM, Colditz GA. Life Years Lost Associated with Obesity-Related Diseases for U.S. Non-Smoking Adults. PLoS One. 2013 Jun 18;8(6):e66550. doi: 10.1371/journal.pone.0066550. Print 2013.
PubMed 23823705
Dulloo AG. Explaining the failures of obesity therapy: willpower attenuation, target miscalculation or metabolic compensation? Int J Obes (Lond). 2012 Nov;36(11):1418-20. doi: 10.1038/ijo.2012.114. No abstract available.
PubMed 23147189
Masicampo EJ, Baumeister RF. Toward a physiology of dual-process reasoning and judgment: lemonade, willpower, and expensive rule-based analysis. Psychol Sci. 2008 Mar;19(3):255-60. doi: 10.1111/j.1467-9280.2008.02077.x.
PubMed 18315798
Littell, Ramon C., George A. Milliken, Walter W. Stroup, Russell D. Wolfinger, and O Schabenberger. 2006. SAS@ for Mixed Models, Second Edition. Cary, NC: SAS Institute.
Gailliot MT, Baumeister RF. The physiology of willpower: linking blood glucose to self-control. Pers Soc Psychol Rev. 2007 Nov;11(4):303-27. doi: 10.1177/1088868307303030.
PubMed 18453466
Hofmann W, Adriaanse M, Vohs KD, Baumeister RF. Dieting and the self-control of eating in everyday environments: an experience sampling study. Br J Health Psychol. 2014 Sep;19(3):523-39. doi: 10.1111/bjhp.12053. Epub 2013 Jun 10.
PubMed 23751109

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Willpower trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study: Snacking, Willpower and Glucose Availability
ClinicalTrials.gov ID: NCT02258477
Acronym / sponsor ID: SWG / 14-1485
Conditions: Willpower
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Johnson & Johnson
Study start: Oct 2014
Primary completion: Jan 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 7 Oct 2014 (estimated)
Results: Posted 4 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Sequence 1 (D-B-A-C)	Active comparator	Dietary Supplement: Sequence 1100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
Sequence 2 (A-D-C-B)	Active comparator	Dietary Supplement: Sequence 2Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
Sequence 3 (C-A-B-D)	Active comparator	Dietary Supplement: Sequence 350 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
Sequence 4 (B-C-D-A)	Active comparator	Dietary Supplement: Sequence 410 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Females ages 18 - 65 years.
Self-identify as regular snackers, with a specific problem food, who have trouble with over-consuming this snack food.
Have intentionally lost weight in the last year and are seeking to maintain that weight loss or have unintentionally gained weight in the last year and are concerned about it.
Generally healthy.

Key exclusion criteria (8 listed)

Pregnant or trying to become pregnant.
Diagnosis of type 1 or type 2 diabetes
Not willing or able to follow study guidelines (ie: consuming the study beverage daily for four weeks, or completing daily compliance logs)
Current smoker (or has stopped smoking within the last 6 months)
Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents, etc).

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
Sequence 1100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.	Dietary supplement	Sequence 1 (D-B-A-C)
Sequence 2Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.	Dietary supplement	Sequence 2 (A-D-C-B)
Sequence 350 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.	Dietary supplement	Sequence 3 (C-A-B-D)
Sequence 410 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.	Dietary supplement	Sequence 4 (B-C-D-A)

Primary outcome

Responses to the Control of Eating Questionnaire
Time frame: 4 weeks
Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome. Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).

2 secondary outcomes

Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.
Time frame: 4 weeks
Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.
Time frame: 4 weeks

Results and safety

Results posted to the registry on 4 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (D-B-A-C)	10	9
Sequence 2 (A-D-C-B)	9	8
Sequence 3 (C-A-B-D)	9	9
Sequence 4 (B-C-D-A)	9	9

Primary outcome: Responses to the Control of Eating Questionnaire

Time frame: 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Control n = 33	100 Calorie Glucose Beverage n = 33	50 Calorie Beverage n = 33	10 Calorie n = 33
Question 1: frequency of food cravings	4.5 (2.1)	5.2 (2.7)	5.1 (2.4)	5.2 (2.4)
Question 2: strength of cravings	4.6 (2.3)	5.0 (2.6)	4.8 (2.6)	5.1 (2.4)
Question 3: difficulty to resisit cravings	4.3 (2.5)	5.2 (2.8)	5.0 (2.6)	5.5 (2.7)
Question 4: frequency of eating due to cravings	4.2 (1.8)	4.8 (2.6)	5.1 (2.4)	4.9 (2.1)
Question 5: Freq of cravings for chocolate	3.6 (2.4)	4.0 (2.7)	3.9 (2.6)	4.6 (2.6)
Question 6: Freq of cravings for other sweet foods	3.8 (2.6)	4.5 (2.8)	4.5 (2.8)	4.6 (2.8)
Question 7: Freq of cravings for fruit	2.5 (1.7)	2.9 (2.0)	2.7 (1.8)	2.9 (1.6)
Question 8: Freq of cravings for savory foods	4.1 (2.1)	4.3 (2.3)	4.6 (2.3)	4.7 (2.4)

Population analysed: 33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the four-week study for each study participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Subjects	0 of 37 (0%)	9 of 37 (24.3%)	Not reported

Limitations and caveats (from the sponsor): The study questionnaire involved limitations as questions were subjective in terms of how subjects defined cravings and snacking behavior. Also, food diaries may not be fully accurate accounts of subjects' actual caloric intake and food consumption.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24261006Hand GA, Shook RP, Paluch AE, Baruth M, Crowley EP, Jaggers JR, Prasad VK, Hurley TG, Hebert JR, O'Connor DP, Archer E, Burgess S, Blair SN. The energy balance study: the design and baseline results for a longitudinal study of energy balance. Res Q Exerc Sport. 2013 Sep;84(3):275-86. doi: 10.1080/02701367.2013.816224.
Background: PubMed 23823705Chang SH, Pollack LM, Colditz GA. Life Years Lost Associated with Obesity-Related Diseases for U.S. Non-Smoking Adults. PLoS One. 2013 Jun 18;8(6):e66550. doi: 10.1371/journal.pone.0066550. Print 2013.
Background: PubMed 23147189Dulloo AG. Explaining the failures of obesity therapy: willpower attenuation, target miscalculation or metabolic compensation? Int J Obes (Lond). 2012 Nov;36(11):1418-20. doi: 10.1038/ijo.2012.114. No abstract available.
Background: PubMed 18315798Masicampo EJ, Baumeister RF. Toward a physiology of dual-process reasoning and judgment: lemonade, willpower, and expensive rule-based analysis. Psychol Sci. 2008 Mar;19(3):255-60. doi: 10.1111/j.1467-9280.2008.02077.x.
BackgroundLittell, Ramon C., George A. Milliken, Walter W. Stroup, Russell D. Wolfinger, and O Schabenberger. 2006. SAS@ for Mixed Models, Second Edition. Cary, NC: SAS Institute.
Results publication: PubMed 18453466Gailliot MT, Baumeister RF. The physiology of willpower: linking blood glucose to self-control. Pers Soc Psychol Rev. 2007 Nov;11(4):303-27. doi: 10.1177/1088868307303030.
Results publication: PubMed 23751109Hofmann W, Adriaanse M, Vohs KD, Baumeister RF. Dieting and the self-control of eating in everyday environments: an experience sampling study. Br J Health Psychol. 2014 Sep;19(3):523-39. doi: 10.1111/bjhp.12053. Epub 2013 Jun 10.

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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.

James O Hill, PhD principal investigator

Anschutz Health and Wellness Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sequence 1, Sequence 2 and Sequence 3 in people with Willpower, run by University of Colorado, Denver 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 4 inclusion and 8 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 4 Mar 2016. 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. 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?

Yes. Results are posted in the registry (first posted 4 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Responses to the Control of Eating Questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02258477, which also lists 7 linked publications.

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 4 Mar 2016.