Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000954628
Ethics application status
Approved
Date submitted
26/08/2014
Date registered
5/09/2014
Date last updated
3/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an “Intuitive Eating” weight management intervention programme
Scientific title
Effectiveness of an intuitive eating weight management programme for adult obese men and women on eating behaviours and health outcomes
Secondary ID [1] 285224 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/Obesity 292853 0
Condition category
Condition code
Diet and Nutrition 293154 293154 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 70 participants will be recruited. The research will be conducted within Waitemata District Health Board’s Nutrition and Dietetic Services’ outpatient service. Nutrition and Dietetics Service receive weight management referrals for patients from specialists and Waitemata District Health Board staff. All clients referred to the Nutrition and Dietetic Services’ outpatient service at North Shore and Waitakere Hospitals between June 2014 and March 2015 will be screened for eligibility.
Participants will be seen in a small group setting with approximately ten participants per group. Participants will be able to bring along a support person to each session. The group education sessions will consist of one x 1.5 hours per week over a four week period (total of four sessions). Sessions will be held in the early evening on the hospital grounds. The group sessions will be structured and use active learning principles. Participants will be given a programme plan and resource hand outs on topics covered during the sessions. Homework activities will be discussed and identified at the end of each session for the participant to complete during the upcoming week.
To identify changes in eating behaviours participants will complete Intuitive eating questionnaire (IES-2) and Dutch Eating Behaviour Questionnaire. To identify changes in food intake participants will complete a short questionnaire regarding food intake in relation to New Zealand Food and Nutrition Guidelines and also a 24 hour food recall. Anthropometric measurements (weight, height, BMI, waist and hip) will also be collected.

The groups will be facilitated by the researcher, a NZ Registered Dietitian trained in an intuitive eating approach and Cognitive Behaviour Therapy.

Post group education at 4, 8 and 12 weeks , participants will be seen by the Researcher/Dietitian for an approximately 30 minute individual session held in the Dietitian Outpatient Office. During the individual session the participant will reflect on the progress made in the preceding weeks relating to their behaviours, eating habits, changes they have made



Intervention code [1] 290099 0
Lifestyle
Intervention code [2] 290100 0
Behaviour
Comparator / control treatment
No treatment period of 1 to 3 months prior to group sessions
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293008 0
Change in Intuitive eating scale - 2
Timepoint [1] 293008 0
at baseline and 1-3 months post enrollment, end of group sessions, individual sessions and 28 weeks after enrolment
Primary outcome [2] 293009 0
Change in Dutch Eating Behaviour Questionnaire
Timepoint [2] 293009 0
at baseline and 1-3 months post enrollment, end of group sessions, individual sessions and 28 weeks after enrolment
Primary outcome [3] 293010 0
Change in dietary balance in comparison to NZ Food and Nutrition Guidelines. Will be assessed using Healthy Eating Questionnaire and 24 hr dietary recall
Timepoint [3] 293010 0
At baseline and 1-3 months post enrolment, end of group sessions, each individual session and 28 weeks after enrolment
Secondary outcome [1] 310138 0
Change in mean weight
Timepoint [1] 310138 0
At baseline and 1-3 months post enrolment, at end of group sessions, at each individual session and 28 weeks after enrolment
Secondary outcome [2] 310139 0
Change in mean BMI
Timepoint [2] 310139 0
At baseline and 1-3 months post enrolment, at end of group sessions, at each individual session and 28 weeks after enrolment
Secondary outcome [3] 310140 0
Change in Waist to Hip ratio
Timepoint [3] 310140 0
At baseline and 1-3 months post enrolment, at end of group sessions, at each individual session and 28 weeks after enrolment
Secondary outcome [4] 310141 0
Changes in perceived quality of life using Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)
Timepoint [4] 310141 0
At baseline and 1-3 months post enrolment, at end of group sessions, at each individual session and 28 weeks after enrolment
Secondary outcome [5] 310320 0
Adherence to treatment - attendance at group sessions and individual sessions
Timepoint [5] 310320 0
At all timepoints - all four group sessions and three individual sessions

Eligibility
Key inclusion criteria
Inclusion criteria
- Patient referred to Nutrition and Dietetic service for weight management
- Male or female
- greater than or equal to 18 years
- BMI greater than or equal to 30
- can attend evening group sessions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
- BMI < 30
- Age < 18 years
- Patients with learning difficulties, severe mental health conditions making attendance at group intervention inappropriate
- Waiting for acceptance for bariatric surgery
- Previous bariatric surgery
- On medications which affect weight and appetite

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/09/2014
Actual
3/09/2014
Date of last participant enrolment
Anticipated
Actual
27/08/2015
Date of last data collection
Anticipated
Actual
24/03/2016
Sample size
Target
70
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 6308 0
New Zealand
State/province [1] 6308 0
Auckland

Funding & Sponsors
Funding source category [1] 289837 0
Self funded/Unfunded
Name [1] 289837 0
Country [1] 289837 0
Primary sponsor type
Individual
Name
Franica Yovich
Address
Team Leader
Nutrition and Dietetics
Waitemata DHB
Private Bag 93-503
Takapuna
Auckland 0740
Country
New Zealand
Secondary sponsor category [1] 288580 0
Individual
Name [1] 288580 0
Associate Professor Rozanne Kruger
Address [1] 288580 0
Associate Professor in Dietetics and Human Nutrition
Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102 904
Albany
Auckland 0745
Country [1] 288580 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291570 0
Health and Disability Ethnics Committee
Ethics committee address [1] 291570 0
Ethics committee country [1] 291570 0
New Zealand
Date submitted for ethics approval [1] 291570 0
Approval date [1] 291570 0
17/07/2014
Ethics approval number [1] 291570 0
14/NTB/90

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50938 0
Miss Franica Yovich
Address 50938 0
Nutrition and Dietetics
Waitemata DHB
Private Bag 93-503
Takapuna
Auckland 0740
Country 50938 0
New Zealand
Phone 50938 0
+64212297058
Fax 50938 0
Email 50938 0
[email protected]
Contact person for public queries
Name 50939 0
Franica Yovich
Address 50939 0
Nutrition and Dietetics
Waitemata DHB
Private Bag 93-503
Takapuna
Auckland 0740
Country 50939 0
New Zealand
Phone 50939 0
+64212077431
Fax 50939 0
Email 50939 0
[email protected]
Contact person for scientific queries
Name 50940 0
Franica Yovich
Address 50940 0
Nutrition and Dietetics
Waitemata DHB
Private Bag 93-503
Takapuna
Auckland 0740
Country 50940 0
New Zealand
Phone 50940 0
+64212077431
Fax 50940 0
Email 50940 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.