How and when is it most feasible to promote weight reduction after delivery in overweight women by motivational interviewing?

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN76738493
• Date of registration: 12/11/2014
• Prospective Registration: No
• Primary sponsor: Stockholm County Council (Sweden)
• Public title: How and when is it most feasible to promote weight reduction after delivery in overweight women by motivational interviewing?
• 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
• Date of first enrolment: 01/11/2014
• Target sample size: 270
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN76738493
• Study type: Interventional
• Study design: Randomised parallel controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Finn Rasmussen

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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.

Primary Outcome(s)

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(s)

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).

Secondary ID(s)

N/A

Source(s) of Monetary Support

Stockholm County Council (Sweden)