Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000331932
Ethics application status
Approved
Date submitted
28/03/2011
Date registered
29/03/2011
Date last updated
29/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Health In Pregnancy and Post Birth: The HIPP Study
Scientific title
A Randomised Controlled Trial of a Specialised Health Coaching Intervention to Prevent Excessive Gestational Weight Gain and Postpartum Weight Retention
Secondary ID [1] 253200 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
HIPPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 258730 0
Gestational weight gain 258731 0
Condition category
Condition code
Diet and Nutrition 258882 258882 0 0
Obesity
Reproductive Health and Childbirth 258883 258883 0 0
Childbirth and postnatal care
Mental Health 258885 258885 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health Coaching, Education Alone

Health Coaching: In addition to the usual care, women in this condition will take part in a Health Coaching intervention program. Our specialised Health Coaching intervention has two components: (1) one-on-one sessions with a Health Coach, and (2) educational group sessions lead by a Health Coach, with key topics the same as described below for the Education Alone group education sessions but with Health Coaching included as well. The two components will be run concurrently for the Intervention group.

- Initial meeting with Health Coach at 14-16 weeks gestation
- First Health Coaching session at 16-18 weeks gestation (face-to-face, 1 hour duration)
- First group education session (Intervention group only) at 20 weeks gestation
- Second group education session (Intervention group only) at 22 weeks gestation
- Second session with Health Coach at 24 weeks gestation (telephonic, 30 mins duration)
- Two brief follow-up sessions with Health Coach between 28-30 weeks (telephonic, 15 mins duration each)

Education Alone: Women in this condition will only receive two education group sessions run by an educator (not a Health Coach) that include the following key topics: dietary and physical activity guidelines in pregnancy; beliefs about pregnancy weight gain and body image; beliefs about postpartum weight loss and body image; mood changes during pregnancy; factors that protect a women against elevated depressive symptoms; and the negative consequence of postpartum weight retention for maternal and infant/child health.

- First group education session (Education Alone group only) at 20 weeks gestation
- Second group education session (Education Alone group only) at 22 weeks gestation
Intervention code [1] 257678 0
Prevention
Intervention code [2] 264130 0
Lifestyle
Intervention code [3] 264131 0
Behaviour
Comparator / control treatment
Usual care: Women in this condition will be case-managed by their obstetrician, midwife or GP as would normally happen. This is the pathway available to the majority of pregnant women in the state of Victoria. Women will be assessed at baseline for current and pre-pregnancy BMI by the research fellow appointed to the study and will have follow-up assessments at the same time as the intervention women.
Control group
Active

Outcomes
Primary outcome [1] 259739 0
Body Mass Index (BMI)
Timepoint [1] 259739 0
16-18 weeks gestation, 32 weeks gestation, at birth, 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [1] 266479 0
Readiness to Change (Readiness to Change 12-item measure, questionnaire)
Timepoint [1] 266479 0
16-18 weeks gestation, 32 weeks gestation, 6 weeks post partum, 6 months postpartum, 12 months postpartum
Secondary outcome [2] 266480 0
Motivation to change (12-item Change measure, questionnaire)
Timepoint [2] 266480 0
16-18 weeks gestation, 32 weeks gestation, 6 weeks post partum, 6 months postpartum, 12 months postpartum
Secondary outcome [3] 266481 0
General distress & psychopathology (Rosenberg Self Esteem Scale, State-Trait Anxiety Inventory, Beck Depression Inventory, Edinburgh Postnatal Depression Scale)
Timepoint [3] 266481 0
16-18 weeks gestation, 32 weeks gestation, 6 weeks post partum, 6 months postpartum, 12 months postpartum
Secondary outcome [4] 266482 0
Body dissatisfaction (Body Attitudes Questionnaire, Pregnancy Figure Rating Scales, Contour Drawing Rating Scales)
Timepoint [4] 266482 0
16-18 weeks gestation, 32 weeks gestation, 6 weeks post partum, 6 months postpartum, 12 months postpartum
Secondary outcome [5] 266483 0
Physical activity (Active Australia Survey)
Timepoint [5] 266483 0
16-18 weeks gestation, 32 weeks gestation, 6 weeks post partum, 6 months postpartum, 12 months postpartum
Secondary outcome [6] 266484 0
Food intake (National Nutrition Survey Food Frequency Questionnaire)
Timepoint [6] 266484 0
16-18 weeks gestation, 32 weeks gestation, 6 weeks post partum, 6 months postpartum, 12 months postpartum

Eligibility
Key inclusion criteria
Pregnant women who have a BMI >18.5 (American IOM cut-off for normal weight), are 18 years of age or older, English speaking, less than 18 weeks gestation
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of disordered eating or diabetes, non-English speaking, greater than 18 weeks gestation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A total of 264 women will be recruited; 132 women randomly assigned into the Health Coaching intervention, 132 women into the education alone group; an additional 132 women have been recruited in another active usual care control group which will be used as a comparison. Concealment of allocation of women to each group will be performed via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted blocks randomised treatment allocation schedule, produced by computer algorithm, will be used for this randomisation process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3484 0
Eastern metropolitan Melbourne

Funding & Sponsors
Funding source category [1] 258152 0
Government body
Name [1] 258152 0
National Health and Medical Research Council (NHMRC)
Country [1] 258152 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Burwood Highway, Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 257316 0
Individual
Name [1] 257316 0
Associate Professor Helen Skouteris
Address [1] 257316 0
School of Psychology
Deakin University
221 Burwood Highway, Burwood, Victoria 3125
Country [1] 257316 0
Australia
Secondary sponsor category [2] 263808 0
Individual
Name [2] 263808 0
Professor Marita McCabe
Address [2] 263808 0
School of Psychology
Deakin University
221 Burwood Highway, Burwood, Victoria 3125
Country [2] 263808 0
Australia
Other collaborator category [1] 251691 0
Individual
Name [1] 251691 0
Professor Jeannette Milgrom
Address [1] 251691 0
Department of Psychology
School of Behavioural Science
University of Melbourne
Melbourne VIC 3081
Country [1] 251691 0
Australia
Other collaborator category [2] 251692 0
Individual
Name [2] 251692 0
Professor Bridie Kent
Address [2] 251692 0
School of Nursing and Midwifery
Deakin University
221 Burwood Highway
Burwood VIC 3125
Australia
Country [2] 251692 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260132 0
Eastern Health HREC
Ethics committee address [1] 260132 0
Eastern Health Research and Ethics Committee
5 Arnold Street
Box Hill, Victoria 3128

PO Box 94, Box Hill, Victoria 3128
ethics@easternhealth.org.au
Ethics committee country [1] 260132 0
Australia
Date submitted for ethics approval [1] 260132 0
25/01/2011
Approval date [1] 260132 0
25/03/2011
Ethics approval number [1] 260132 0
E40/1011

Summary
Brief summary
The aim of this project is test the effects of an intervention we have designed that targets behavioural changes in relation to eating and physical activity as well as changes in psychological factors such as motivation, confidence, mood, and body image concerns, with the aim of maintaining healthy weight gain during pregnancy.
Trial website
TBA
Trial related presentations / publications
Skouteris, H., Hartley-Clark, L., McCabe, M., Milgrom, J., Kent, B., Herring, S., & Gale, J. (2010). Preventing excessive gestational weight gain: A systematic review of interventions. Obesity Reviews, 11, 757 – 768. ERA Ranking A*
Public notes

Contacts
Principal investigator
Name 31964 0
Address 31964 0
Country 31964 0
Phone 31964 0
Fax 31964 0
Email 31964 0
Contact person for public queries
Name 15211 0
Associate Professor Helen Skouteris
Address 15211 0
School of Psychology

Deakin University

221 Burwood Highway

Burwood Victoria 3125

Australia
Country 15211 0
Australia
Phone 15211 0
61 3 9251 7699
Fax 15211 0
61 3 9244 6858
Email 15211 0
helen.skouteris@deakin.edu.au
Contact person for scientific queries
Name 6139 0
Associate Professor Helen Skouteris
Address 6139 0
School of Psychology

Deakin University

221 Burwood Highway

Burwood Victoria 3125

Australia
Country 6139 0
Australia
Phone 6139 0
61 3 9251 7699
Fax 6139 0
61 3 9244 6858
Email 6139 0
helen.skouteris@deakin.edu.au

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
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Documents added automatically
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