Food CravingsNCT00668993
Randomized Clinical Trial Investigating Efficacy of EFT (Emotional Freedom Technique) for Food Cravings
A study testing EFT - the Emotional Freedom technique in people with Food Cravings, run by Soul Medicine Institute at 1 site in Australia.
Trial summary
This pilot study will examine one issue only in weight loss - food cravings in overweight (i.e. BMI between 25-29.9) or obese (BMI greater than 30) consumers. Food craving is hypothesized to be an important intervening causal variable and the development of obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Cravings
- What is being tested?
- EFT - the Emotional Freedom technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2008to Feb 2009
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Criteria will consist of participants being:
- over 18 years old and under 60 years and not suffering any severe psychological impairment
- 2) not currently receiving treatment (psychological or medical) for their food cravings
- 3) agree to be contacted for follow-up testing.
- Women and men will be included
Who cannot join
- Active diagnoses from the SCID II and subjects taking 'heavy' psychotropic which can suppress feelings, cravings and sensitivity will be excluded.
- Known sufferers of diabetes (Type I and II) and hypoglycemia will be excluded due to any physiological aetiology (effects related) to food cravings.
- Pregnant women will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Emotional Freedom Technique (EFT) Versus a Waitlist for Food Cravings: A Randomized Clinical Trial
This pilot study will examine one issue only in weight loss - food cravings in overweight (i.e. BMI between 25-29.9) or obese (BMI greater than 30) consumers. Food craving is hypothesized to be an important intervening causal variable and the development of obesity.
This randomized clinical trial will explore whether a relatively under researched energy based therapeutic procedure, Emotional Freedom Techniques (EFT), can reduce food cravings in participants under laboratory-controlled conditions, and compare this to a waitlist group. The following foods will be tested: chocolate, salty foods (e.g. chips, crisps, salted nuts), sweet carbohydrate foods (eg. cakes, biscuits, soft/soda drinks), carbohydrate foods which are neither sweet nor salty such as white refined foods such as bread), and caffeinated items.
Read more
Research examining energy based procedures (e.g. EFT) combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. It is often referred to as "psychological acupuncture". Few adequately controlled studies have been conducted on EFT however acupuncture has been quite extensively studied, with hundreds of research reports published (see attached references).
Screening will occur over the telephone with one of the chosen self report questionnaires - the Food Craving Inventory (FCI; White et al., 2002). The FCI is a reliable and valid measure for the assessment of cravings for specific types of foods: High Fats, Sweets, Carbohydrates/Starches, and Fast Food Fats, all of which comprise the higher order construct of "food craving" or the FCI Total score (White et al., 2002). Higher numbers for each of the subscales reflect greater cravings for that food type with the highest score being 185. Scores of 93 or higher during the screen will be used to admit subjects to the next diagnostic interview phase of the trial. In addition, subjects will be asked their weight and height in order to ascertain their BMI and this will be confirmed in the diagnostic interview with a standardized weight machine.
The Structured Clinical Interview (SCID-II; Spitzer, Williams, Gibbon, \& First, 1990) has 12 groups of questions corresponding to12 personality disorders and will be used as a diagnostic tool in a face-to-face interview with subjects who are suitable from the telephone screen. The aim is to exclude any active diagnoses from the DSM-IV in order to obtain the purest non clinic sample possible. All subjects will be notified by letter of the outcome of their diagnostic interview and those unsuitable for the trial will be told they did not meet selection criteria. Suitable practitioners who would be able to provide individual support for the food cravings will be provided in written format. Subjects who meet a diagnostic category will be informed of this and appropriate referral will be offered.
Participants will be randomly assigned (using the NHMRC Clinical Trials Centre service) to a free group EFT treatment condition or a non treatment waitlist control condition of the same duration (4 weeks). This design ensures that potential treatment gains are neither due to the mere passage of time nor regression to the mean. To limit attrition from waitlist conditions, several contacts will be made with the waiting clients. Prescheduled phone contacts, for example, may maintain adherence to the waitlist condition.
Prior to treatment all subjects will be weighed and height measured for their BMI status and food craving outcome measures (pre, post and follow-up) will be measured using:
- SUDS rating (subjective) in daily food diaries (food diaries were chosen as a method that best measures real-life eating behaviour)
- Power of Food Scale (Didie, 2003)
- Food Craving Inventory (White et al., 2002)
Three aspects of eating behaviour will be measured using the Revised Restraint Scale (Herman \& Polivy, 1980). The items are summed for a total score that ranges from 0 to 40. High scores indicate chronic dieting in which the individual is constantly cycling on and off the diet, typically without any substantial weight loss. Dietary restraint appears to play a causal role in the development of eating disorders and obesity and loss of control over intake. Food cravings may trigger these eating behaviours.
The Symptom Assessment 45 (SA-45, Strategic Advantage, 1998) will be used to assess symptomatology across nine psychiatric domains and as measures of the outcome of the psychological intervention.
Demographic information will be collected in questionnaire format at the beginning of the study.
The EFT intervention will consist of 4 sessions (2 hours duration) with homework and will be based on standard delivery of EFT, as per founder Gary Craig's training for level 1 EFT certification ( see http://www.emofree.com/WorkShop/workshop-guidelines.htm#Level%201).
Read the detailed description
Participants will be recruited through community announcements in print advertisements, radio, and television. Inclusion and exclusion criteria will be highlighted in the advertising. Criteria will consist of: participants being (l) over 18 years old and under 60 years and not suffering any severe psychological impairment, (2) not currently receiving treatment (psychological or medical) for their food cravings, (3) agree to be contacted for follow-up testing. Women and men will be included, and (4) active diagnoses from the SCID II and subjects taking 'heavy' psychotropic (see attached list) which can suppress feelings, cravings and sensitivity will be excluded.
Known sufferers of diabetes (Type I and II) and hypoglycemia will be excluded due to any physiological aetiology (effects related) to food cravings.
Eligible applicants will be offered participation in the study through an informed consent procedure. Self report questionnaires will be issued as part of the study and a demographic questionnaire will be included in this. All identifying information will be destroyed once data has been analysed.
Unsuitable participants will be advised in letter form that they did not meet selection criteria, and a list of suitable practitioners will be included should they wish to address their food craving.The study will use a Research Assistant to screen participants, administer questionnaires and collate data. Separate qualified clinicians to the investigating researchers will be used to deliver the EFT treatment condition.
The treatments will be delivered in a number of appropriate venues. Analysis will examine pre versus post effects for each intervention to highlight any differences in self report, and a repeated measures ANOVA will examine the effect of time on all the self report scores.
The following questions will be addressed: does EFT reduce food cravings and weight more than no intervention? It is anticipated that because this is a pilot study, results may indicate positive direction for these questions only. Due to anecdotal suggestion that EFT has long lasting effects (see http://www.emofree.com/articles.aspx?id=19), it is hypothesised that food cravings will reduce significantly with the EFT intervention and remain consistent at follow-up points. It is expected that the waitlist condition will remain unaffected prior to any treatment condition. Increases in eating restraint and decreases in SUDS ratings and general psychopathology are expected with the EFT intervention post treatment and are expected to stay constant at 3-, 6- and 12-month follow-up. Gender and age will be examined.
A standard process will be used for informed consent, including a general information sheet for subjects and consent form indicating any areas of psychological risk, benefits of the study, self report questionnaire details and follow-up procedures. Detailed information about what constitutes a food craving will be given to all subjects as well as information about voluntary involvement and study withdrawal.
- Conditions
- Food Cravings
- Being tested
- EFT - the Emotional Freedom technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFT - the Emotional Freedom techniqueBehavioural
Also called EFT is often described as "psychological acupuncture"
EFT combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. It is often referred to as "psychological acupuncture". Few adequately controlled studies have been conducted on EFT however acupuncture has been quite extensively studied, with hundreds of research reports published
| Study group | Role | What they receive |
|---|---|---|
| A, B | Experimental | A is treatment group B is waitlist group Receives: Behavioral: EFT - the Emotional Freedom technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease or elimination of food craving
Measured: 6 and 12 months follow up
Secondary outcomes (1)
changes in weight
Measured: 6 and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food CravingsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soul Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Griffith University
- Investigators
- Peta Stapleton, PhD, Principal investigator, Griffith University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668993
- Sponsor's protocol ID
- SMI-GU-42708
- Status last verified
- Sep 2009
- First submitted
- 27 Apr 2008
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emotional Freedom Technique (EFT) Versus a Waitlist for Food Cravings: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00668993
- Acronym / sponsor ID
- SMI-GU-42708
- Conditions
- Food Cravings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soul Medicine InstituteUniversity, hospital or other
- Collaborators
- Griffith University
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Apr 2008 (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 pilot study will examine one issue only in weight loss - food cravings in overweight (i.e. BMI between 25-29.9) or obese (BMI greater than 30) consumers. Food craving is hypothesized to be an important intervening causal variable and the development of obesity.
This randomized clinical trial will explore whether a relatively under researched energy based therapeutic procedure, Emotional Freedom Techniques (EFT), can reduce food cravings in participants under laboratory-controlled conditions, and compare this to a waitlist group. The following foods will be tested: chocolate, salty foods (e.g. chips, crisps, salted nuts), sweet carbohydrate foods (eg. cakes, biscuits, soft/soda drinks), carbohydrate foods which are neither sweet nor salty such as white refined foods such as bread), and caffeinated items.
Research examining energy based procedures (e.g. EFT) combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. It is often referred to as "psychological acupuncture". Few adequately controlled studies have been conducted on EFT however acupuncture has been quite extensively studied, with hundreds of research reports published (see attached references).
Screening will occur over the telephone with one of the chosen self report questionnaires - the Food Craving Inventory (FCI; White et al., 2002). The FCI is a reliable and valid measure for the assessment of cravings for specific types of foods: High Fats, Sweets, Carbohydrates/Starches, and Fast Food Fats, all of which comprise the higher order construct of "food craving" or the FCI Total score (White et al., 2002). Higher numbers for each of the subscales reflect greater cravings for that food type with the highest score being 185. Scores of 93 or higher during the screen will be used to admit subjects to the next diagnostic interview phase of the trial. In addition, subjects will be asked their weight and height in order to ascertain their BMI and this will be confirmed in the diagnostic interview with a standardized weight machine.
The Structured Clinical Interview (SCID-II; Spitzer, Williams, Gibbon, \& First, 1990) has 12 groups of questions corresponding to12 personality disorders and will be used as a diagnostic tool in a face-to-face interview with subjects who are suitable from the telephone screen. The aim is to exclude any active diagnoses from the DSM-IV in order to obtain the purest non clinic sample possible. All subjects will be notified by letter of the outcome of their diagnostic interview and those unsuitable for the trial will be told they did not meet selection criteria. Suitable practitioners who would be able to provide individual support for the food cravings will be provided in written format. Subjects who meet a diagnostic category will be informed of this and appropriate referral will be offered.
Participants will be randomly assigned (using the NHMRC Clinical Trials Centre service) to a free group EFT treatment condition or a non treatment waitlist control condition of the same duration (4 weeks). This design ensures that potential treatment gains are neither due to the mere passage of time nor regression to the mean. To limit attrition from waitlist conditions, several contacts will be made with the waiting clients. Prescheduled phone contacts, for example, may maintain adherence to the waitlist condition.
Prior to treatment all subjects will be weighed and height measured for their BMI status and food craving outcome measures (pre, post and follow-up) will be measured using:
- SUDS rating (subjective) in daily food diaries (food diaries were chosen as a method that best measures real-life eating behaviour)
- Power of Food Scale (Didie, 2003)
- Food Craving Inventory (White et al., 2002)
Three aspects of eating behaviour will be measured using the Revised Restraint Scale (Herman \& Polivy, 1980). The items are summed for a total score that ranges from 0 to 40. High scores indicate chronic dieting in which the individual is constantly cycling on and off the diet, typically without any substantial weight loss. Dietary restraint appears to play a causal role in the development of eating disorders and obesity and loss of control over intake. Food cravings may trigger these eating behaviours.
The Symptom Assessment 45 (SA-45, Strategic Advantage, 1998) will be used to assess symptomatology across nine psychiatric domains and as measures of the outcome of the psychological intervention.
Demographic information will be collected in questionnaire format at the beginning of the study.
The EFT intervention will consist of 4 sessions (2 hours duration) with homework and will be based on standard delivery of EFT, as per founder Gary Craig's training for level 1 EFT certification ( see http://www.emofree.com/WorkShop/workshop-guidelines.htm#Level%201).
Detailed description
Participants will be recruited through community announcements in print advertisements, radio, and television. Inclusion and exclusion criteria will be highlighted in the advertising. Criteria will consist of: participants being (l) over 18 years old and under 60 years and not suffering any severe psychological impairment, (2) not currently receiving treatment (psychological or medical) for their food cravings, (3) agree to be contacted for follow-up testing. Women and men will be included, and (4) active diagnoses from the SCID II and subjects taking 'heavy' psychotropic (see attached list) which can suppress feelings, cravings and sensitivity will be excluded.
Known sufferers of diabetes (Type I and II) and hypoglycemia will be excluded due to any physiological aetiology (effects related) to food cravings.
Eligible applicants will be offered participation in the study through an informed consent procedure. Self report questionnaires will be issued as part of the study and a demographic questionnaire will be included in this. All identifying information will be destroyed once data has been analysed.
Unsuitable participants will be advised in letter form that they did not meet selection criteria, and a list of suitable practitioners will be included should they wish to address their food craving.The study will use a Research Assistant to screen participants, administer questionnaires and collate data. Separate qualified clinicians to the investigating researchers will be used to deliver the EFT treatment condition.
The treatments will be delivered in a number of appropriate venues. Analysis will examine pre versus post effects for each intervention to highlight any differences in self report, and a repeated measures ANOVA will examine the effect of time on all the self report scores.
The following questions will be addressed: does EFT reduce food cravings and weight more than no intervention? It is anticipated that because this is a pilot study, results may indicate positive direction for these questions only. Due to anecdotal suggestion that EFT has long lasting effects (see http://www.emofree.com/articles.aspx?id=19), it is hypothesised that food cravings will reduce significantly with the EFT intervention and remain consistent at follow-up points. It is expected that the waitlist condition will remain unaffected prior to any treatment condition. Increases in eating restraint and decreases in SUDS ratings and general psychopathology are expected with the EFT intervention post treatment and are expected to stay constant at 3-, 6- and 12-month follow-up. Gender and age will be examined.
A standard process will be used for informed consent, including a general information sheet for subjects and consent form indicating any areas of psychological risk, benefits of the study, self report questionnaire details and follow-up procedures. Detailed information about what constitutes a food craving will be given to all subjects as well as information about voluntary involvement and study withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, B | Experimental | Behavioral: EFT - the Emotional Freedom techniqueA is treatment group B is waitlist group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Criteria will consist of participants being:
- 2) not currently receiving treatment (psychological or medical) for their food cravings
- 3) agree to be contacted for follow-up testing.
- Women and men will be included
Key exclusion criteria (3 listed)
- Active diagnoses from the SCID II and subjects taking 'heavy' psychotropic which can suppress feelings, cravings and sensitivity will be excluded.
- Known sufferers of diabetes (Type I and II) and hypoglycemia will be excluded due to any physiological aetiology (effects related) to food cravings.
- Pregnant women will be excluded
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 |
|---|---|---|
| EFT - the Emotional Freedom techniqueAlso: EFT is often described as "psychological acupuncture"EFT combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. It is often referred to as "psychological acupuncture". Few adequately controlled studies have been conducted on EFT however acupuncture has been quite extensively studied, with hundreds of research reports published | Behavioural | A, B |
Primary outcome
Decrease or elimination of food craving
Time frame: 6 and 12 months follow up
1 secondary outcome
changes in weight
Time frame: 6 and 12 month follow up
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 22 Sep 2009.
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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.
Peta Stapleton, PhD principal investigator
Griffith 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 EFT - the Emotional Freedom technique in people with Food Cravings, run by Soul Medicine Institute at 1 site in Australia.
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 5 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: finished, as of the sponsor's last update on 22 Sep 2009. 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 Australia. 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?
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?
Decrease or elimination of food craving (time frame: 6 and 12 months follow up). 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 22 Sep 2009.