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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00668993

Registration number

NCT00668993

Ethics application status

Date submitted

27/04/2008

Date registered

29/04/2008

Date last updated

22/09/2009

Titles & IDs

Public title

Randomized Clinical Trial Investigating Efficacy of EFT (Emotional Freedom Technique) for Food Cravings

Scientific title

The Emotional Freedom Technique (EFT) Versus a Waitlist for Food Cravings: A Randomized Clinical Trial

Secondary ID [1]

SMI-GU-42708

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Food Cravings

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

BEHAVIORAL - EFT - the Emotional Freedom technique

Experimental: A, B - A is treatment group B is waitlist group

BEHAVIORAL: EFT - the Emotional Freedom technique
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

Intervention code [1]

BEHAVIORAL

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Decrease or elimination of food craving

Timepoint [1]

6 and 12 months follow up

Secondary outcome [1]

changes in weight

Timepoint [1]

6 and 12 month follow up

Eligibility

Key inclusion criteria

* 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

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

* 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment

Single group

Other design features

Phase

Not applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/04/2008

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/02/2009

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

School of Medicine - Meadowbrook

Recruitment postcode(s) [1]

4131 - Meadowbrook

Funding & Sponsors

Primary sponsor type

Other

Name

Soul Medicine Institute

Address

Country

Other collaborator category [1]

Other

Name [1]

Griffith University

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

Brief 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.

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:

1. SUDS rating (subjective) in daily food diaries (food diaries were chosen as a method that best measures real-life eating behaviour)
2. Power of Food Scale (Didie, 2003)
3. 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).

Trial website

https://clinicaltrials.gov/study/NCT00668993

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Peta Stapleton, PhD

Address

Griffith University

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00668993

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00668993