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 |
| Protocol serial number | N/A |
| Sponsor | University Hospital Centre of Quebec (CHUQ) (Canada) |
| Funders | Foundation of Stars (Fondation des Etoiles) (Canada), Hospital Centre of Laval University (CHUL) (Centre Hospitalier de l'Universite Laval)(CHUL) (Canada) |
- 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
Scientific
2705 boul. Laurier
Local RC-9800
Quebec
G1V 4G2
Canada
| isabelle.marc@crchul.ulaval.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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) |
| Key secondary outcome measure(s) |
1. Gestational weight gain |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
G1V 4G2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
