Condition category
Pregnancy and Childbirth
Date applied
21/10/2014
Date assigned
12/11/2014
Last edited
17/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In 2012, it was found that 36% of Swedish pregnant women were overweight or obese at their first visit to their antenatal care clinic. Being overweight during pregnancy increases the risk of complications occurring both before and after childbirth and can lead to health problems in the longer term. Antenatal care is free of charge in Sweden and almost all pregnant women visit a midwife. Motivational Interviewing (MI) is a patient-centred counselling session. There is a lot of evidence to suggest that MI works well as getting people to change their behaviour patterns, but more evidence is needed on whether it can successfully promote good eating and exercise habits. Here, we want to see whether antenatal care MI sessions will promote good diet and exercise habits in pregnant woman. We will investigate whether MI prevents pregnant woman from becoming overweight or help them to lose any weight gained during pregnancy once their child is born.

Who can participate?
Women aged between 18-39, pregnant with their first child and with a BMI 27.0-33.9 kg/m2. They should also be living in Stockholm County and fluent in Swedish.

What does the study involve?
First of all, all participants are weighed and their diet and physical activity assessed. They are then randomly allocated into one of four groups. Those in group 1 attend four MI sessions during their pregnancy. Those in group 2 attend four MI sessions 3-5 months after they have given birth. Those in group 3 have two MI sessions during pregnancy and two MI sessions after they have given birth. Those in group 4 are in a control group and are given their usual standard of care. The MI sessions are given by suitably trained counsellors and focus on eating and exercise habits. Weight, dietary and exercise habits, blood pressure and general quality of life are assed for all participants 52 weeks after giving birth.

What are the possible benefits and risks of participating?
Possible benefits include improvements in health for both mothers and their children. There are no risks for participants.

Where is the study run from?
1. Stockholm County Council (Centre for Epidemiology and Community Medicine) (Sweden)
2. Karolinska Institutet (Child and Adolescent Public Health Epidemiology, Department of Public Health Sciences), Stockholm, (Sweden)

When is the study starting and how long is it expected to run for?
November 2014 to December 2020

Who is funding the study?
1. Stockholm County Council (Sweden)
2. Karolinska Institutet (Sweden)

Who is the main contact?
Professor Finn Rasmussen
finn.rasmussen@ki.se

Trial website

http://www.irisstudien.se/

Contact information

Type

Scientific

Primary contact

Prof Finn Rasmussen

ORCID ID

Contact details

Department of Public Health Sciences
Karolinska Institutet
Stockholm
171 77
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

IRIS: How and when is it most feasible and cost-effective to promote weight reduction after delivery in overweight
women by motivational interviewing? A randomised controlled trial

Acronym

IRIS

Study hypothesis

Motivational interviewing and feedback on dietary and physical activity habits can prevent postpartum weight retention among overweight/obese women and the effects differ depending on whether it is delivered during pregnancy, postpartum or both.

Ethics approval

Ethical Review Board in Stockholm, Sweden; 19/03/2014; ref: 2014/350-31/2

Study design

Randomised parallel controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

http://www.irisstudien.se/delta

Condition

Prevention of obesity and promotion of healthy eating and physical activity habits

Intervention

Motivational interviewing (MI) is a brief psychological counselling method characterized by an emphasis on promoting motivation for behavior change by helping a client to explore and resolve ambivalence about change.

Women in the intervention arms are offered four individual MI consultations with a counsellor with high proficiency in MI. The MI sessions are either offered i) during the second trimester of pregnancy, ii) 3-5 months postpartum, or iii) both during pregnancy and postpartum. The first MI session is face-to-face and initiated by a feedback on the dietary and physical activity assessment. The second and third sessions are held via telephone and the fourth session is conducted in person or via telephone depending on preference of the woman.

In contrast, women allocated to the control group receive antenatal care as usual together with general calls about basic nutrition and physical activity knowledge.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Postpartum weight retention 12 months after delivery. Weight and height are assessed by study staff the first MI session/general visit(approximately gestational week 15) by scale and height meter, and at follow-up 52 weeks postpartum. Weight is also measured at the routine visits in antenatal care (approximately gestational weeks 10-12, 25 and 37/38) and at delivery and data are assessed from medical records.

Secondary outcome measures

1. Dietary and physical activity habits. Diet is assessed at baseline (gestational week 11-13) and follow-up (1 year after delivery) by four-days food records using a web-based method. Physical activity is measured during seven consecutive days using an accelerometer at baseline, at the end of the second trimester, 5-6 months postpartum, and at follow-up (12 months after delivery).
2. Self-efficacy - measured by a questionnaire (an instrument developed by Kendall et al and back translated to Swedish) at baseline, at the end of the second trimester, 5-6 months postpartum, and at follow-up (12 months after delivery).
3. Blood pressure is registered in routine antenatal care (approximately gestational weeks 10-12) and data are drawn from medical records as well as at follow-up (12 months postpartum). Blood pressure will measured in a sitting position in the right arm after 5 minutes rest according to the antenatal care´s guidelines.
4. Body composition is assessed by bioelectric impedance at follow-up (12 months after delivery).
5. Gestational weight gain
6. Quality of life will be assessed for the health economic evaluation by a questionnaire (the SF-36 instrument) at baseline and follow-up (12 months after delivery).

Overall trial start date

01/11/2014

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Nulliparous or primiparous women at gestational week 8-11
2. Age 18-39 years
3. BMI 27.0-34.9 kg/m2
4. Fluent in Swedish

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

270 women

Participant exclusion criteria

1. Severe psychologic or somatic illness
2. Bariatric surgery patient
3. Alcohol or narcotic addiction
4. Insulin-dependent diabetes

Recruitment start date

01/11/2014

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Public Health Sciences
Stockholm
171 77
Sweden

Sponsor information

Organisation

Stockholm County Council (Sweden)

Sponsor details

Box 1497
Solna
171 29
Sweden

Sponsor type

Government

Website

http://www.sll.se/

Funders

Funder type

Government

Funder name

Stockholm County Council (Sweden)

Alternative name(s)

Stockholm County Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/08/2016: Inclusion criteria 3 was changed from 27.0-33.9 kg/m2 to BMI 27.0-34.9 kg/m2