NCT02420145

Brief Summary

The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to no specific intervention on weight-related outcomes, well-being, and health behaviour in 60 females with abdominal obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

April 9, 2015

Last Update Submit

September 22, 2015

Conditions

Obesity, Abdominal

Outcome Measures

Primary Outcomes (1)

  • Waist circumference

    Week 12

Secondary Outcomes (17)

  • BMI

    Week 12

  • Body weight

    Week 12

  • Quality of life

    Week 12

  • Self esteem

    Week 12

  • Body awareness

    Week 12

  • +12 more secondary outcomes

Study Arms (2)

Yoga

EXPERIMENTAL

This group will participate in 12 weeks of yoga

Behavioral: Yoga

Waitlist

NO INTERVENTION

No intervention

Interventions

YogaBEHAVIORAL

12 weeks of yoga, twice weekly for 90 minutes plus a whole-day workshop

Yoga

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Waist circumference at least 88cm
  • Body mass index at least 25
  • Sedentary
  • Physical and mental ability to participate in the yoga intervention
  • Willingness to participate in at least 18 of 24 yoga sessions and the whole-day workshop

You may not qualify if:

  • Dementia
  • Psychosis
  • Severe hypertension (diastolic blood pressure more than 120mmHg)
  • Type 1 diabetes or insulin-dependent 2 diabetes
  • Coronary artery disease
  • Myocardial infarction
  • Lung embolism
  • Stroke
  • Regular physical activity or yoga practice
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Essen, 45276, Germany

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Yoga

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 17, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

DE(1)