NCT04487158

Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A Weight Loss Trial

Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A 12 Month Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 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).

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Small Changes	The Small Changes program is an evidence-based 6-month weight-management program. The program runs weekly for 3 months followed by by-weekly contact for 3-months (1x in-person group and 1x phone call). This program uses behaviour change strategies to help with weight loss. The Small Changes approach is different from traditional dieting programs because it encourages modest changes to diet and physical activity which are not overly taxing to maintain. Participants are asked to reduce their nutritional intake by 200-400 calories per day. You will also be asked to increase their daily step count by 2000-3000 steps. Weekly intervention topics include: Monitoring, Nutrition, Physical Activity, Breaking the Chain, External Cues, Mindful Eating, Body Image, Stress, Sleep, Social Support, Social Eating, and the Stoplight Guide.
BEHAVIORAL	INSPIRE	The INSPIRE program is a modification to the Small Changes program. It combines elements of positive psychology and behaviour change to help with weight loss. The first four weeks of the program are oriented towards improving well-being and include topics such as values, self-compassion/mindfulness, character strengths, and gratitude. The remaining 8 weeks mirrors the Small Changes program in making modest changes to diet and physical activity to achieve weight loss. Participants are asked to reduce their nutritional intake by 200-400 calories per day. Participants will also be asked to increase their daily step count by 2000-3000 steps.

Timeline

• Start date: 2019-11-22
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2020-07-27
• Last updated: 2020-07-27

Locations

1 site across 1 country: Canada