Preventing overweight and obesity in women through mindful eating, dance and yoga exercises
| ISRCTN | ISRCTN87234794 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87234794 |
| Secondary identifying numbers | YDME |
- Submission date
- 27/02/2023
- Registration date
- 27/02/2023
- Last edited
- 30/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Many current treatment options for managing overweight and obesity consist of rather strict diet and exercise regimes that are difficult to implement as a lifelong routine. Therefore, alternative initiatives such as mindful eating and pleasure-oriented physical activity with more focus on implementation and enjoyment are needed to reverse the obesity epidemic. Mindful eating is an approach focusing on inner hunger and satiety (fullness) signals. YogaDance is a new exercise approach combining elements of yoga and dance. The aim of this study is to investigate the individual and combined effects of mindful eating and YogaDance.
Who can participate?
Healthy, inactive women with overweight or obesity
What does the study involve?
Participants were randomly allocated to one of four groups for 8 weeks: mindful eating alone, YogaDance alone, the combination of mindful eating and YogaDance, or control. The combined mindful eating and YogaDance intervention group followed three weekly YogaDance classes and a mindful eating workshop every second week (in total four workshops) for a total period of 8 weeks. The mindful eating intervention group only attended the four mindful eating workshops and the YogaDance intervention group only followed the three weekly YogaDance classes. The control group did not participate in the YogaDance classes nor the mindful eating workshops. Fat mass, body weight, waist circumference, other physiological outcomes, behavioral and quality of life are measured.
What are the possible benefits and risks of participating?
Benefits include weight loss as well as improved eating behavior and quality of life.
Where is the study run from?
University of Copenhagen (Denmark)
When is the study starting and how long is it expected to run for?
February 2021 to April 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Christian Ritz, ritz@sdu.dk
Contact information
Scientific
National Institute of Public Health
Studiestraede 6
Copenhagen K
DK-1455
Denmark
 ORCID ID |
0000-0002-5095-0624 |
|---|---|
| Phone | +45 (0)65509696 |
| ritz@sdu.dk |
Study information
| Study design | Parallel-arm open-label randomized controlled superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Fitness/sport facility |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effects of mindful eating and YogaDance among overweight and obese women – an exploratory randomized controlled trial |
| Study objectives | The aim of this study was to explore the effect of combining mindful eating and the novel YogaDance approach in overweight and obese women. The hypothesis was that the combination would lead to a reduction in total body fat mass (compared to a control group). |
| Ethics approval(s) | Approved 01/07/2021, Ethics Committee of the capital region of Denmark (De Videnskabsetiske Komiteer, Region Hovedstaden, Borgervaenget 3, st., 2100 Copenhagen OE, Denmark; +45 (0)38 66 63 95; vek@regionh.dk), ref: H-21013705 |
| Health condition(s) or problem(s) studied | Prevention of overweight and obesity in women |
| Intervention | Participants were allocated by block randomization to one of three intervention groups (mindful eating alone, YogaDance alone, or mindful eating and YogaDance combined) or the control group in a 1:1:1:1 ratio. This trial design enabled the assessment of the two approaches mindful eating and YogaDance separately as well as jointly. The combined mindful eating and YogaDance intervention group followed three weekly YogaDance classes and a mindful eating workshop every second week (in total four workshops) for a total period of 8 weeks. This training intensity was selected to ensure participant adherence and meet the recommendations by WHO for physical activity for adults (i.e., 150 minutes at moderate intensity or 75 minutes at high intensity per week). The mindful eating intervention group only attended the four mindful eating workshops and the YogaDance intervention group only followed the three weekly YogaDance classes. The control group did not participate in the YogaDance classes nor the mindful eating workshops. |
| Intervention type | Other |
| Primary outcome measure | Fat mass is measured using a dual-energy x-ray absorptiometry (DXA) scanner (Lunar iDXA with CoreScan module, GE Healthcare, Denmark) at baseline and again at end of the study after 8 weeks |
| Secondary outcome measures | Measured at baseline and after the intervention was completed (at 8 weeks): 1. Body weight measured using a calibrated digital scale (Tanita WB-110MA) 2. BMI defined as body weight divided by height squared 3. Waist circumference measured using a non-elastic band 4. Fat percent measured using a DXA scanner 5. Fat-free mass measured using a DXA scanner 6. Visceral fat measured using a DXA scanner 7. Bone mineral density measured using a DXA scanner 8. Blood pressure measured using a validated automatic blood pressure monitor (UA-787 Plus) 9. Quality of life measured using the WHO-QOL-100 questionnaire 10. Eating behavior measured using a Danish version of the IES-2 questionnaire 11. Energy intake measured using 3-day dietary records 12. Physical activity measured using the International Physical Activity Questionnaires (IPAQ) |
| Overall study start date | 10/02/2021 |
| Completion date | 10/04/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 61 |
| Key inclusion criteria | 1. Women between 18 and 65 years of age 2. Body mass index (BMI) between 25-35 kg/m² and/or a waist circumference of ≥80 cm 3. Healthy 4. Have an inactive lifestyle, defined as <2.5 hours of light physical activity per week or <1 hour of moderate to hard physical activity per week |
| Key exclusion criteria | 1. Pregnant, breastfeeding or plan to become pregnant within the study period 2. Self-reported severe disease (including cancer, cardiovascular disease [CVD], type 1 or 2 diabetes, osteoporosis) 3. Self-reported eating disorder (e.g., anorexia, bulimia, orthorexia, binge eating disorder) 4. Following a very restrictive diet (i.e. excluding several food items) 5. Participation in other studies |
| Date of first enrolment | 01/11/2021 |
| Date of final enrolment | 31/01/2022 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Rolighedsvej 26
Frederiksberg C
DK-1958
Denmark
Sponsor information
University/education
Department of Nutrition and Exercise
Rolighedsvej 26
Frederiksberg C
DK-1958
Denmark
| Phone | +45 (0)35333671 |
|---|---|
| fma@nexs.ku.dk | |
| Website | https://www.nexs.ku.dk |
"ROR" |
https://ror.org/035b05819 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed nutrition or public health journal in March-June 2023. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Sofie Hauerberg Henninger (sofiehenninger@gmail.com) and Anna Yde Fibieger (annafibieger@gmail.com). Pseudo-anonymized individual-level data will be available upon presenting of a statistical analysis plan or study protocol. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/03/2023 | 30/03/2023 | Yes | No |
Editorial Notes
30/03/2023: Publication reference added.
27/02/2023: Trial's existence confirmed by the Ethics Committee of the capital region of Denmark.
