NCT00668993

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. 1.SUDS rating (subjective) in daily food diaries (food diaries were chosen as a method that best measures real-life eating behaviour)
  2. 2.Power of Food Scale (Didie, 2003)
  3. 3.Food Craving Inventory (White et al., 2002)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

10 months

First QC Date

April 27, 2008

Last Update Submit

September 19, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Decrease or elimination of food craving

    6 and 12 months follow up

Secondary Outcomes (1)

  • changes in weight

    6 and 12 month follow up

Study Arms (1)

A, B

EXPERIMENTAL

A is treatment group B is waitlist group

Behavioral: EFT - the Emotional Freedom technique

Interventions

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

Also known as: EFT is often described as "psychological acupuncture"
A, B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Criteria will consist of participants being:
  • l) over 18 years old and under 60 years and not suffering any severe psychological impairment
  • \) not currently receiving treatment (psychological or medical) for their food cravings
  • \) agree to be contacted for follow-up testing.
  • Women and men will be included

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine

Meadowbrook, Queensland, 4131, Australia

Location

Study Officials

  • Peta Stapleton, PhD

    Griffith University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2008

First Posted

April 29, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations