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 IOMs 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