Condition category
Pregnancy and Childbirth
Date applied
18/02/2011
Date assigned
28/04/2011
Last edited
28/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Isabelle Marc

ORCID ID

Contact details

2705 boul. Laurier
Local RC-9800
Quebec
G1V 4G2
Canada
isabelle.marc@crchul.ulaval.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Hypnotherapy for adherence to nutritional and physical activity recommendations during pregnancy in obese pregnant women: feasibility of an intervention, a randomised controlled trial

Acronym

Study hypothesis

Obesity exposes mother and foetus to higher risks of perinatal complications. Institute of Medicine (IOM) recently suggested that obese women gain between 5 and 9 kg during pregnancy. Almost 30% of pregnant women are overweight and 60% of them had a gestational weight gain (GWG) that did not meet IOM’s recommendations. Weight gain during pregnancy over the recommended values exposes the mother and her infant to higher risks for perinatal adverse outcomes independently of the body mass index (BMI), such as diabetes or large for gestational age infants. Lifestyle interventions might improve nutritional habits and the practice of physical activity during pregnancy. Psychological interventions have to be targeted to elicit effective responses to intervention programs. Cerebral structures act as a network to influence feeding behaviour and appetite control. A hypnotherapy intervention was thus developed to enhance motivation and adherence to healthy lifestyle habits (i.e. healthy nutrition and physical activity) during pregnancy in obese pregnant women.

Hypnotherapy is a promising tool for inducing changes in attitudes and perceptions in the management of eating disorders. By increasing self-esteem, self-efficacy and resilience, it may assist pregnant obese women with integrating healthy behaviours in a meaningful way in order to achieve successful perinatal outcomes. We hypothesised that a standardised hypnotherapy intervention for obese women during pregnancy will enhance motivation and adherence to nutritional and physical recommendations.

Ethics approval

Ethics Committee of the Clinical Research, University Hospital Centre of Quebec ((Comite d'ethique de la recherche clinique du Centre Hospitalier Universitaire de Quebec) approved on 22nd April 2009, reference number:129.05.07(5-09-03-04)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gestational obesity

Intervention

If the woman is randomised in the hypnosis group, she will receive four sessions of hypnotherapy (weeks 16, 18, 20 and 24). She is also given the option to attend two additional hypnotherapy sessions at weeks 27 and 32. Each session is delivered individually, lasting between 30 to 40 min in duration and is provided by one experienced hypnotherapist who reliably mastered all key elements of the intervention after training and observation. The intervention protocol is standardised in a manual for all six sessions. A written script is read to the participants.

If the woman is randomised in the control group, she does not receive any hypnotherapy session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Physical activity level as assessed by the Pregnancy Physical Activity Questionnaire (PPAQ) in the previous month (baseline, 25-26 weeks of gestation, and 35-36 weeks of gestation)
2. Total energy intake as assessed by a food frequency questionnaire in the previous month (baseline, 25-26 weeks of gestation, and 35-36 weeks of gestation)

Secondary outcome measures

1. Gestational weight gain
2. Birth weight
3. Adherence to the programme
4. Satisfaction with the programme

Overall trial start date

24/07/2009

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women, aged more than or equal to 18 years, with an intra-uterine pregnancy of < 15 weeks of gestation
2. Single foetus
3. Body mass index > 29 kg.m-2
4. Signature of consent form for the study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30

Participant exclusion criteria

1. Women with an antenatal diagnosis of chronic hypertension, diabetes or renal insufficiency
2. Women taking antidepressants
3. Women who received a verbal notification from their physicians about a medical or obstetrical contraindication for exercise

Recruitment start date

24/07/2009

Recruitment end date

01/09/2011

Locations

Countries of recruitment

Canada

Trial participating centre

2705 boul. Laurier
Quebec
G1V 4G2
Canada

Sponsor information

Organisation

University Hospital Centre of Quebec (CHUQ) (Canada)

Sponsor details

Centre Hospitalier de l'Université Laval (CHUQ)
2705 boul. Laurier
Quebec
G1V 4G2
Canada
isabelle.marc@crchul.ulaval.ca

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Foundation of Stars (Fondation des Etoiles) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hospital Centre of Laval University (CHUL) (Centre Hospitalier de l'Universite Laval)(CHUL) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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