Status:
UNKNOWN
Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A Weight Loss Trial
Lead Sponsor:
University of British Columbia
Conditions:
Obesity
Eligibility:
FEMALE
25-75 years
Phase:
NA
Brief Summary
The study is designed to compare short- and long-term changes in body weight (kg) and subjective well-being in adult females with obesity who have been randomized to receive one of two 6-month treatme...
Detailed Description
Rates of obesity continues to rise in Canada and worldwide, which is related to the presence and increased severity of multiple co-morbid illnesses as well as a reduction in overall quality and quanti...
Eligibility Criteria
Inclusion
- Female between the ages of 25 to 75
- BMI between 30 and 45
- Not currently participating in any other weight management programs
- Self-reports wanting to lose weight
- Willing to follow recommendations in the study protocol and attend weekly group intervention for 12 weeks and a 3-month follow-up group (one in-person group per month and one phone call per month)
- Ability to attend 4 assessment appointments over the course of the study period (at baseline, 3-months, 6-months, 12-months).
- Willing to be randomized into any of the two study arms and willing to adhere to guidelines and recommendations associated with the study arm they are randomized into
Exclusion
- Cannot commit to weekly group times. Participants must be available for at least one group time of each intervention arm in order to be eligible to participate.
- Participated in a weight loss intervention in the past six months
- Participants who are pregnant (or less than 6 months post partum) or planning to become pregnant in the next 12 months
- Weight loss of \> 5kg (\~11 lb) in the previous 6 months
- History of, or current, clinically diagnosed eating disorder or exhibiting clinical symptoms of an eating disorder but undiagnosed (EDE-Q ≥ 4.0 unless clinical judgement indicates otherwise)
- Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (as measured by the PAR-Q+) where a doctor's note is not provided
- Resting systolic blood pressure \>160 mmHg or resting diastolic blood pressure \>100 mmHg
- If any of the following medical conditions are present: Insulin dependent diabetes; Previous surgical procedure for weight loss; Major surgery within the previous 6 months; A history of heart problems (e.g., angina, bypass surgery, myocardial infarction) within the previous 6 months; Implanted cardiac defibrillator or pacemaker; Currently (or within the past 5 years) being treated for cancer; Inflammatory Bowel Disease (i.e., chronic inflammatory gastrointestinal disease such as Crohn's Disease or Ulcerative Colitis); Chronic Pain (e.g., fibromyalgia) that would prevent the participant from engaging in physical activity
- The participant is currently experiencing elevated symptoms of depression
- The participant is planning to move within the study period
- The participant consumes more than 14 alcoholic drinks per week or more than 3 drinks per day
Key Trial Info
Start Date :
November 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04487158
Start Date
November 22 2019
End Date
February 1 2021
Last Update
July 27 2020
Active Locations (1)
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1
University of British Columbia Okanagan
Kelowna, British Columbia, Canada, V1V2J8