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

ISRCTN	ISRCTN45084927
DOI	https://doi.org/10.1186/ISRCTN45084927
Secondary identifying numbers	N/A

Submission date: 18/02/2011
Registration date: 28/04/2011
Last edited: 28/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Isabelle Marc
Scientific

2705 boul. Laurier
Local RC-9800
Quebec
G1V 4G2
Canada

Email	isabelle.marc@crchul.ulaval.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	24/07/2009
Completion date	01/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	30
Key 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
Key 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
Date of first enrolment	24/07/2009
Date of final enrolment	01/09/2011

Locations

Countries of recruitment

Canada

Study participating centre

2705 boul. Laurier

Quebec
G1V 4G2
Canada

Sponsor information

University Hospital Centre of Quebec (CHUQ) (Canada)
University/education

Centre Hospitalier de l'Université Laval (CHUQ)
2705 boul. Laurier
Quebec
G1V 4G2
Canada

Email	isabelle.marc@crchul.ulaval.ca
"ROR"	https://ror.org/006a7pj43

Funders

Funder type

University/education

Foundation of Stars (Fondation des Etoiles) (Canada)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan