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Clinical Trial 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 treatment conditions: INSPIRE or Small Changes. The Small Changes approach is an evidence-based behavioural weight management program that uses relative and modest changes in nutrition and physical activity to produce a caloric deficit. The INSPIRE program is a modification of the Small Changes program that spends the first four weeks on improving well-being via psychological interventions.


Clinical Trial 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 quantity of life. Traditional behavioural interventions have demonstrated efficacy in producing initial weight loss; however, a continued challenge for these programs is long-term weight loss maintenance. The Small Changes program is an alternative approach to weight loss that encourages modest changes to nutrition and physical activity that are sustainable long-term. Although promising, this approach has failed to consistently demonstrate clinically significant weight loss. It has been suggested that psychological factors, such as low levels of subjective well-being (negative affect, positive affect, and life satisfaction), may work in opposition of an individual's weight management goals. Thus, the integration of psychological interventions with a Small Changes approach has the potential to improve well-being and weight loss concurrently. Based on previous research, psychological interventions may be effectively utilized if they are implemented at the beginning of an intervention where early changes in well-being promote greater adherence to health behaviour change. To date, no behavioural intervention that integrates psychological approaches at treatment outset has been evaluated. The primary aim of the study is to determine the feasibility, acceptability, and efficacy of a novel group-based integrative behavioural and psychological intervention (INSPIRE) on change in weight and subjective well-being outcomes compared to an evidence-based behavioural intervention for weight loss (Small Changes). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04487158
Study type Interventional
Source University of British Columbia
Contact
Status Active, not recruiting
Phase N/A
Start date November 22, 2019
Completion date February 2021

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